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An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease (GEMINI LTS)

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ClinicalTrials.gov Identifier: NCT00790933
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Ulcerative Colitis
Crohn's Disease
Intervention Drug: Vedolizumab
Enrollment 2243
Recruitment Details Participants took part in study at 298 sites in North America, Western/Northern Europe, Central Europe, Eastern Europe, Asia, Australia and Africa from 22 May 2009 to 31 October 2017.
Pre-assignment Details Participants with a diagnosis of ulcerative colitis and Crohn's disease who participated in previous studies: C13004 (NCT00619489), C13006 (NCT00783718), C13007 (NCT00783692) and C13011 (NCT01224171) and DeNovo participants were enrolled into 1 treatment group, vedolizumab 300 mg, 30-minute intravenous (IV) infusion, every 4 weeks (Q4W).
Arm/Group Title Vedolizumab 300 mg (C13006) Vedolizumab 300 mg (C13007) Vedolizumab 300 mg (C13011) Vedolizumab 300 mg (C13004) Vedolizumab 300 mg (C13008 De Novo Participants)
Hide Arm/Group Description Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab every 8 weeks (Q8W), IV infusion up to Week 52. Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52. Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78. Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn's disease (CD) or ulcerative colitis (UC) not treated in a previous study.
Period Title: Overall Study
Started 675 726 384 37 421
Completed 237 246 115 23 145
Not Completed 438 480 269 14 276
Reason Not Completed
Adverse Event             94             119             65             5             69
Protocol Violation(s)             8             18             7             0             12
Lack of Efficacy             192             176             130             1             121
Study Terminated by Sponsor             0             0             1             0             0
Withdrawal by Subject             123             120             52             6             50
Lost to Follow-up             13             31             10             1             15
Reason Not Specified             8             16             4             1             9
Arm/Group Title Vedolizumab 300 mg (C13006) Vedolizumab 300 mg (C13007) Vedolizumab 300 mg (C13011) Vedolizumab 300 mg (C13004) Vedolizumab 300 mg (C13008 De Novo Participants) Total
Hide Arm/Group Description Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab Q8W, IV infusion up to Week 52. Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52. Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78. Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn's disease (CD) or ulcerative colitis (UC) not treated in a previous study. Total of all reporting groups
Overall Number of Baseline Participants 675 726 384 37 421 2243
Hide Baseline Analysis Population Description
Safety population was defined as all participants who received any amount of vedolizumab in this study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
41.2  (13.27) 37.3  (12.26) 38.3  (12.87) 43.9  (14.24) 39.3  (14.23) 39.1  (13.19)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
<65
646
  95.7%
710
  97.8%
376
  97.9%
35
  94.6%
400
  95.0%
2167
  96.6%
>=65
29
   4.3%
16
   2.2%
8
   2.1%
2
   5.4%
21
   5.0%
76
   3.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
Female
280
  41.5%
384
  52.9%
216
  56.3%
20
  54.1%
215
  51.1%
1115
  49.7%
Male
395
  58.5%
342
  47.1%
168
  43.8%
17
  45.9%
206
  48.9%
1128
  50.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
Hispanic or Latino
29
   4.3%
12
   1.7%
7
   1.8%
0
   0.0%
19
   4.5%
67
   3.0%
Not Hispanic or Latino
631
  93.5%
700
  96.4%
372
  96.9%
36
  97.3%
400
  95.0%
2139
  95.4%
Unknown or Not Reported
15
   2.2%
14
   1.9%
5
   1.3%
1
   2.7%
2
   0.5%
37
   1.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
White
557
  82.5%
641
  88.3%
349
  90.9%
36
  97.3%
398
  94.5%
1981
  88.3%
Black
10
   1.5%
17
   2.3%
7
   1.8%
0
   0.0%
8
   1.9%
42
   1.9%
Native Hawaiian or Other Pacific Islander
2
   0.3%
0
   0.0%
1
   0.3%
0
   0.0%
0
   0.0%
3
   0.1%
Asian
98
  14.5%
66
   9.1%
14
   3.6%
0
   0.0%
9
   2.1%
187
   8.3%
American Indian or Alaskan Native
2
   0.3%
0
   0.0%
0
   0.0%
1
   2.7%
0
   0.0%
3
   0.1%
Other
6
   0.9%
2
   0.3%
11
   2.9%
0
   0.0%
5
   1.2%
24
   1.1%
Not Reported
0
   0.0%
0
   0.0%
2
   0.5%
0
   0.0%
1
   0.2%
3
   0.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Australia Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
41
   6.1%
30
   4.1%
8
   2.1%
0
   0.0%
21
   5.0%
100
   4.5%
Hong Kong Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
1
   0.1%
2
   0.3%
0
   0.0%
0
   0.0%
0
   0.0%
3
   0.1%
India Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
39
   5.8%
24
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
63
   2.8%
Malaysia Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
8
   1.2%
6
   0.8%
3
   0.8%
0
   0.0%
0
   0.0%
17
   0.8%
New Zealand Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
9
   1.3%
8
   1.1%
1
   0.3%
0
   0.0%
8
   1.9%
26
   1.2%
Singapore Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
1
   0.1%
1
   0.1%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.1%
South Africa Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
13
   1.9%
15
   2.1%
8
   2.1%
0
   0.0%
0
   0.0%
36
   1.6%
Korea, Republic Of Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
34
   5.0%
18
   2.5%
7
   1.8%
0
   0.0%
0
   0.0%
59
   2.6%
Taiwan, Province Of China Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
1
   0.1%
3
   0.4%
0
   0.0%
0
   0.0%
0
   0.0%
4
   0.2%
Czech Republic Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
34
   5.0%
67
   9.2%
36
   9.4%
0
   0.0%
69
  16.4%
206
   9.2%
Greece Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
5
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
   0.2%
Hungary Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
12
   1.8%
47
   6.5%
22
   5.7%
0
   0.0%
17
   4.0%
98
   4.4%
Poland Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
53
   7.9%
20
   2.8%
9
   2.3%
0
   0.0%
0
   0.0%
82
   3.7%
Romania Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
0
   0.0%
4
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
4
   0.2%
Serbia Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
0
   0.0%
2
   0.3%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.1%
Slovakia Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
0
   0.0%
14
   1.9%
17
   4.4%
0
   0.0%
0
   0.0%
31
   1.4%
Bulgaria Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
5
   0.7%
6
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
11
   0.5%
Estonia Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
9
   1.3%
5
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
14
   0.6%
Israel Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
2
   0.3%
12
   1.7%
21
   5.5%
0
   0.0%
21
   5.0%
56
   2.5%
Latvia Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
0
   0.0%
1
   0.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.0%
Russia Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
46
   6.8%
24
   3.3%
0
   0.0%
15
  40.5%
0
   0.0%
85
   3.8%
Turkey Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
6
   0.9%
3
   0.4%
0
   0.0%
0
   0.0%
0
   0.0%
9
   0.4%
Ukraine Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
0
   0.0%
9
   1.2%
0
   0.0%
0
   0.0%
0
   0.0%
9
   0.4%
Canada Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
73
  10.8%
98
  13.5%
75
  19.5%
22
  59.5%
87
  20.7%
355
  15.8%
United States Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
169
  25.0%
166
  22.9%
109
  28.4%
0
   0.0%
147
  34.9%
591
  26.3%
Austria Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
13
   1.9%
9
   1.2%
3
   0.8%
0
   0.0%
0
   0.0%
25
   1.1%
Belgium Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
48
   7.1%
48
   6.6%
33
   8.6%
0
   0.0%
46
  10.9%
175
   7.8%
Denmark Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
2
   0.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.1%
France Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
11
   1.6%
25
   3.4%
10
   2.6%
0
   0.0%
0
   0.0%
46
   2.1%
Germany Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
10
   1.5%
25
   3.4%
4
   1.0%
0
   0.0%
5
   1.2%
44
   2.0%
Iceland Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
3
   0.4%
3
   0.4%
0
   0.0%
0
   0.0%
0
   0.0%
6
   0.3%
Ireland Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
1
   0.1%
1
   0.1%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.1%
Italy Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
12
   1.8%
7
   1.0%
4
   1.0%
0
   0.0%
0
   0.0%
23
   1.0%
Netherlands Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
2
   0.3%
5
   0.7%
12
   3.1%
0
   0.0%
0
   0.0%
19
   0.8%
Norway Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
7
   1.0%
5
   0.7%
2
   0.5%
0
   0.0%
0
   0.0%
14
   0.6%
Spain Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
1
   0.1%
4
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
5
   0.2%
Sweden Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
0
   0.0%
5
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
5
   0.2%
Switzerland Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
2
   0.3%
4
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
6
   0.3%
United Kingdom Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
2
   0.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.1%
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 675 participants 726 participants 384 participants 37 participants 421 participants 2243 participants
74.10  (17.934) 71.70  (19.600) 71.29  (18.951) 77.66  (18.907) 75.45  (18.814) 73.15  (18.900)
BMI   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 675 participants 726 participants 384 participants 37 participants 0 participants 1822 participants
25.39  (5.391) 24.61  (6.039) 24.56  (5.783) 27.11  (6.523) 24.94  (5.779)
[1]
Measure Description: Body Mass Index = weight (kg)/[height (m)^2]. BMI was not calculated for de novo participants as height was not collected for these participants. BMI data was available for only 1822 participants.
[2]
Measure Analysis Population Description: BMI was not calculated for de novo participants due to no collection of height information.
1.Primary Outcome
Title Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time Frame From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
Arm/Group Title Vedolizumab 300 mg (UC) Vedolizumab 300 mg (CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004 and C13006 with a diagnosis of Ulcerative colitis (UC).
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13007 and C13011 with a diagnosis of Crohn's disease.
Overall Number of Participants Analyzed 894 1349
Measure Type: Number
Unit of Measure: percentage of participants
TEAEs 93 96
SAEs 31 41
2.Primary Outcome
Title Number of Participants With Markedly Abnormal Safety Laboratory Findings
Hide Description A laboratory value was considered a marked abnormality if it met the predefined criteria or parameters and the on-treatment value was more extreme than the Baseline value for the following parameters: hemoglobin <= 70 g/L, absolute lymphocyte count <0.5 X 10^9/L, leukocytes <2.0 X 10^9/L (absolute value), platelets <75.0 X 10^9/L, absolute neutrophil Count <1.0 X 10^9/L, prothrombin time >1.25 x upper limit of normal (ULN), alanine aminotransferase (ALT) >3.0 x ULN, aspartate aminotransferase (AST) >3.0 x ULN, bilirubin >2.0 x ULN, amylase >2.0 x ULN, lipase >2.0 x ULN.
Time Frame From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
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Hide Analysis Population Description
The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
Arm/Group Title Vedolizumab 300 mg (UC) Vedolizumab 300 mg (CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004 and C13006 with a diagnosis of Ulcerative colitis (UC).
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13007 and C13011 with a diagnosis of Crohn's disease.
Overall Number of Participants Analyzed 894 1349
Measure Type: Number
Unit of Measure: participants
Hemoglobin <= 70 g/L 16 11
Absolute Lymphocyte Count <0.5 X 10^9/L 28 56
Leukocytes <2.0 X 10^9/L (Absolute Value) 1 3
Platelets <75.0 X 10^9/L 2 5
Absolute Neutrophil Count <1.0 X 10^9/L 9 9
Prothrombin Time >1.25 x ULN 42 37
ALT >3.0 x ULN 30 47
AST >3.0 x ULN 35 34
Bilirubin >2.0 x ULN 12 14
Amylase >2.0 x ULN 16 36
Lipase >2.0 x ULN 27 41
3.Primary Outcome
Title Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements
Hide Description Vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure, and temperature) measurements were collected throughout the study. Any clinically significant mean change in vital signs over time as assessed by the investigator was reported as a TEAE.
Time Frame From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
Arm/Group Title Vedolizumab 300 mg (UC) Vedolizumab 300 mg (CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004 and C13006 with a diagnosis of Ulcerative colitis (UC).
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13007 and C13011 with a diagnosis of Crohn's disease.
Overall Number of Participants Analyzed 894 1349
Measure Type: Number
Unit of Measure: percentage of participants
0 0
4.Primary Outcome
Title Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings
Hide Description A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs.
Time Frame From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
Arm/Group Title Vedolizumab 300 mg (UC) Vedolizumab 300 mg (CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004 and C13006 with a diagnosis of Ulcerative colitis (UC).
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13007 and C13011 with a diagnosis of Crohn's disease.
Overall Number of Participants Analyzed 894 1349
Measure Type: Number
Unit of Measure: participants
7 7
5.Primary Outcome
Title Time to Major Inflammatory Bowel Disease (IBD) - Related Events
Hide Description IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis and Crohn's disease.
Time Frame Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years)
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Hide Analysis Population Description
Efficacy population included participants who received at least one dose of vedolizumab and had at least one postbaseline disease activity measurement.
Arm/Group Title Vedolizumab 300 mg
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks.
Overall Number of Participants Analyzed 2142
Median (95% Confidence Interval)
Unit of Measure: weeks
IBD-related events, UC Number Analyzed 845 participants
NA [1] 
(NA to NA)
IBD-related events, CD Number Analyzed 1297 participants
NA [1] 
(NA to NA)
[1]
Median was not estimable due to the low number of participants with events.
6.Primary Outcome
Title Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28
Hide Description The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 38 67 76 52 62 71 127 134 150 161
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 125.34  (34.895) 129.12  (34.289) 124.37  (31.632) 122.33  (31.114) 127.56  (33.718) 127.11  (30.537) 123.88  (31.620) 124.35  (33.310) 131.44  (27.715) 132.14  (32.245)
Change at Week 28 60.00  (41.165) 62.71  (34.600) 62.53  (35.072) 57.17  (38.851) 57.52  (42.561) 51.48  (34.576) 41.71  (36.508) 40.49  (39.733) 42.90  (32.581) 30.84  (34.614)
7.Primary Outcome
Title Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52
Hide Description The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
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Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 32 65 70 49 56 63 107 117 132 134
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 123.53  (36.160) 131.17  (33.675) 125.03  (32.560) 120.29  (30.894) 129.46  (34.799) 128.69  (30.461) 125.30  (30.075) 125.31  (34.140) 130.63  (28.446) 132.71  (33.108)
Change at Week 52 66.84  (41.733) 59.89  (33.170) 61.06  (37.386) 59.31  (34.837) 58.87  (40.707) 52.30  (29.385) 44.31  (37.923) 47.38  (37.687) 47.07  (30.463) 37.33  (40.232)
8.Primary Outcome
Title Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76
Hide Description The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 29 63 63 45 55 58 91 106 118 113
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 123.66  (36.115) 131.31  (33.726) 123.87  (31.752) 120.00  (29.667) 128.47  (34.724) 129.06  (31.694) 124.89  (31.629) 125.89  (34.478) 130.75  (28.587) 132.46  (33.245)
Change at Week 76 65.53  (40.584) 59.88  (35.290) 64.27  (32.443) 59.91  (34.449) 55.05  (47.181) 52.85  (36.486) 47.43  (35.811) 46.32  (36.397) 50.59  (30.794) 40.14  (39.305)
9.Primary Outcome
Title Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100
Hide Description The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 27 58 58 45 49 55 84 96 112 104
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 124.70  (37.614) 130.90  (34.361) 124.52  (30.033) 120.89  (29.745) 129.53  (35.261) 128.25  (32.333) 123.50  (29.662) 128.35  (33.793) 132.41  (28.538) 132.48  (32.305)
Change at Week 100 61.83  (41.505) 62.46  (32.502) 62.83  (34.475) 57.04  (38.448) 58.53  (45.644) 53.40  (32.651) 49.89  (36.806) 46.95  (34.691) 52.50  (32.267) 38.52  (36.982)
10.Primary Outcome
Title Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124
Hide Description The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 27 58 54 43 47 48 80 82 95 97
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 127.33  (36.470) 130.83  (34.399) 123.65  (30.180) 119.77  (29.963) 132.36  (34.573) 130.01  (33.454) 122.91  (29.869) 129.08  (33.576) 132.75  (28.131) 131.56  (31.567)
Change at Week 124 63.94  (44.480) 60.94  (37.769) 63.71  (34.542) 61.91  (36.288) 53.91  (44.023) 53.74  (34.514) 46.62  (38.435) 47.60  (40.634) 54.47  (29.636) 40.35  (41.543)
11.Primary Outcome
Title Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148
Hide Description The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
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Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 27 54 53 41 43 46 76 83 93 92
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 127.33  (36.470) 131.95  (34.649) 123.02  (29.685) 119.07  (30.344) 132.23  (35.877) 130.25  (34.108) 122.01  (28.967) 128.66  (34.624) 133.36  (28.616) 132.38  (32.172)
Change at Week 148 60.66  (41.786) 62.72  (33.786) 65.81  (33.232) 60.41  (36.074) 54.53  (48.036) 56.08  (32.954) 52.30  (39.123) 49.40  (36.880) 54.50  (32.874) 42.13  (40.030)
12.Primary Outcome
Title Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172
Hide Description The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
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Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 24 53 49 37 43 43 71 76 89 80
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 130.25  (36.650) 132.93  (34.216) 123.47  (30.141) 120.49  (30.221) 131.60  (36.013) 132.31  (33.860) 120.70  (27.535) 127.42  (34.779) 133.34  (28.981) 131.69  (32.229)
Change at Week 172 58.67  (42.513) 62.20  (33.187) 62.16  (33.969) 65.43  (35.350) 54.91  (40.758) 53.92  (33.132) 51.55  (40.714) 47.97  (35.121) 56.02  (33.863) 41.18  (40.805)
13.Primary Outcome
Title Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196
Hide Description The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 27 50 46 37 41 41 66 71 62 51
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 127.33  (36.470) 135.33  (33.596) 122.00  (30.129) 119.35  (31.651) 130.39  (36.410) 132.16  (34.217) 121.15  (28.703) 126.44  (34.826) 136.55  (27.551) 137.27  (30.844)
Change at Week 196 63.19  (38.061) 59.13  (33.318) 68.89  (34.578) 64.81  (36.563) 58.90  (46.107) 55.67  (32.453) 52.22  (42.363) 49.41  (35.662) 49.05  (30.390) 36.35  (41.424)
14.Primary Outcome
Title Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248
Hide Description The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 21 38 36 32 32 31 38 45 3 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 116.05  (31.747) 133.61  (32.538) 120.28  (30.875) 116.63  (32.888) 131.81  (35.906) 129.37  (31.455) 122.00  (27.231) 125.93  (35.080) 127.00  (63.930) 128.00  (35.749)
Change at Week 248 76.21  (38.693) 57.52  (31.841) 69.56  (38.680) 65.72  (34.776) 54.97  (41.658) 58.76  (35.250) 51.39  (45.950) 53.04  (38.830) 73.00  (48.446) 72.00  (32.156)
15.Primary Outcome
Title Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300
Hide Description The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable (NA) for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Overall Number of Participants Analyzed 7 14 13 9 8 16 4 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 100.71  (21.831) 137.50  (30.478) 120.38  (24.401) 119.67  (33.463) 134.88  (36.957) 121.38  (30.133) 120.25  (19.085) 162.50  (47.376)
Change at Week 300 94.29  (38.612) 55.43  (41.694) 67.54  (27.823) 69.00  (41.192) 53.00  (41.542) 72.00  (35.219) 73.50  (12.342) 2.00  (5.657)
16.Primary Outcome
Title Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352
Hide Description The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352
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Hide Analysis Population Description
ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Overall Number of Participants Analyzed 1 1 3 1 2 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 89.00 [1]   (NA) 120.00 [2]   (NA) 118.00  (32.047) 70.00 [2]   (NA) 137.00  (28.284) 126.00 [2]   (NA)
Change at Week 352 123.00 [2]   (NA) 86.00 [2]   (NA) 66.00  (33.181) 131.00 [2]   (NA) 37.50  (28.991) 84.00 [2]   (NA)
[1]
Standard deviation (SD) was not calculated for 1 participant.
[2]
SD was not calculated for 1 participant.
17.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 38 67 76 52 62 71 127 136 151 162
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 39.57  (8.599) 41.15  (8.313) 40.05  (7.634) 37.05  (7.522) 37.87  (8.113) 39.09  (7.771) 37.92  (8.355) 36.81  (8.274) 40.06  (8.631) 39.20  (7.306)
Change at Week 28 10.20  (8.792) 8.22  (9.015) 8.89  (7.110) 9.85  (8.789) 12.46  (8.900) 9.60  (7.620) 6.48  (8.514) 7.74  (9.310) 7.07  (8.752) 5.67  (7.695)
18.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 38 67 76 52 62 71 127 136 151 162
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 39.98  (11.349) 40.70  (11.226) 38.28  (11.039) 35.49  (11.139) 38.53  (10.631) 37.70  (12.423) 36.60  (11.545) 38.04  (12.567) 40.87  (11.385) 39.29  (11.535)
Change at Week 28 8.36  (13.096) 11.10  (11.098) 11.52  (12.464) 13.35  (11.857) 10.88  (12.396) 10.94  (12.386) 7.48  (12.061) 6.34  (13.161) 6.48  (10.809) 3.72  (12.377)
19.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 32 64 69 49 56 63 107 118 133 135
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 39.94  (8.930) 41.72  (8.314) 40.12  (7.694) 36.75  (7.510) 37.82  (8.301) 39.23  (7.807) 37.87  (7.992) 37.40  (8.171) 40.51  (8.454) 39.27  (7.469)
Change at Week 52 9.55  (10.155) 8.57  (7.889) 9.77  (6.766) 9.43  (9.088) 12.97  (9.147) 9.98  (7.824) 7.48  (8.800) 8.97  (8.743) 8.37  (8.401) 6.72  (7.842)
20.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 32 64 69 49 56 63 107 118 133 135
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 39.33  (11.878) 41.18  (11.150) 38.29  (11.062) 35.43  (11.445) 39.45  (9.910) 38.98  (11.963) 36.80  (11.052) 38.54  (12.379) 40.32  (11.333) 39.16  (11.518)
Change at Week 52 10.27  (12.895) 10.40  (10.777) 12.18  (11.506) 12.68  (11.843) 10.54  (11.719) 8.40  (11.598) 8.27  (11.770) 7.86  (13.129) 6.71  (10.363) 6.23  (12.306)
21.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 29 63 63 45 55 58 90 106 120 114
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 39.79  (8.801) 41.33  (8.517) 40.07  (7.625) 37.03  (7.675) 37.92  (8.353) 39.59  (7.809) 37.53  (8.286) 37.47  (8.147) 40.73  (8.552) 39.25  (7.667)
Change at Week 76 9.69  (9.714) 8.97  (8.891) 10.54  (6.416) 10.48  (7.797) 11.98  (9.496) 10.28  (7.651) 7.77  (8.397) 8.82  (8.501) 9.73  (8.461) 7.31  (8.436)
22.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 29 63 63 45 55 58 90 106 120 114
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 39.41  (11.201) 41.30  (10.710) 38.26  (10.974) 35.50  (11.582) 38.86  (10.046) 38.52  (12.244) 36.68  (11.947) 39.03  (12.679) 40.32  (11.673) 39.16  (11.712)
Change at Week 76 9.64  (14.272) 8.52  (11.462) 10.51  (12.334) 12.92  (13.174) 8.02  (14.020) 9.13  (13.719) 8.27  (12.720) 8.26  (12.809) 7.77  (10.989) 7.16  (13.144)
23.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 27 58 58 45 49 54 84 96 114 105
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 41.26  (8.825) 41.03  (8.260) 40.29  (7.480) 36.97  (7.677) 38.11  (8.169) 39.59  (7.989) 37.26  (7.974) 37.90  (8.297) 41.13  (8.579) 39.28  (7.458)
Change at Week 100 10.28  (8.418) 9.41  (7.934) 9.42  (7.556) 11.18  (8.322) 12.97  (9.396) 10.78  (8.926) 8.47  (8.096) 9.45  (8.747) 9.70  (8.869) 7.40  (8.473)
24.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 27 58 58 45 49 54 84 96 114 105
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 39.56  (11.833) 41.10  (11.140) 38.21  (10.885) 35.61  (11.568) 38.76  (10.215) 37.41  (11.857) 36.61  (11.894) 39.43  (12.474) 40.39  (11.559) 39.04  (11.604)
Change at Week 100 8.80  (14.395) 9.87  (10.552) 10.82  (12.303) 10.64  (13.629) 8.94  (13.798) 9.98  (11.450) 8.25  (12.562) 7.93  (11.053) 7.66  (10.685) 6.94  (13.189)
25.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 27 58 54 43 47 48 80 83 97 98
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 41.75  (7.947) 41.08  (8.219) 39.88  (7.332) 37.00  (7.854) 38.58  (8.078) 39.31  (8.279) 37.09  (8.044) 38.36  (8.240) 41.10  (8.747) 39.01  (7.363)
Change at Week 124 10.12  (9.685) 7.91  (9.483) 10.15  (8.551) 11.79  (8.053) 12.87  (8.803) 11.01  (8.319) 8.36  (7.495) 7.77  (9.228) 10.56  (8.804) 9.27  (8.274)
26.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 27 58 54 43 47 48 80 83 97 98
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 40.34  (12.065) 40.81  (11.132) 37.85  (11.106) 35.29  (11.668) 38.59  (9.956) 38.33  (12.409) 39.04  (12.421) 36.64  (11.938) 40.87  (11.156) 38.90  (11.427)
Change at Week 124 9.53  (16.289) 10.02  (10.734) 9.70  (12.781) 11.35  (12.681) 9.20  (12.521) 10.38  (13.230) 8.50  (12.808) 8.78  (13.283) 7.73  (11.048) 6.26  (13.274)
27.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 27 58 53 40 43 46 76 82 20 24
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 41.75  (7.947) 41.33  (8.438) 39.86  (7.312) 36.68  (8.055) 39.22  (7.511) 39.21  (8.303) 36.94  (8.087) 37.99  (8.430) 43.32  (10.405) 38.77  (7.024)
Change at Week 148 9.08  (9.090) 9.35  (8.228) 10.34  (6.524) 12.15  (9.941) 12.54  (9.695) 11.26  (7.231) 9.37  (8.223) 8.94  (8.442) 9.81  (8.727) 10.39  (6.824)
28.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 27 54 53 40 43 46 76 82 20 24
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 40.34  (12.065) 41.20  (11.115) 37.48  (11.101) 35.05  (11.782) 38.56  (10.221) 39.21  (12.368) 36.71  (12.021) 39.36  (12.612) 42.40  (8.427) 41.67  (10.953)
Change at Week 148 6.89  (14.522) 9.79  (11.176) 11.09  (12.299) 10.47  (12.517) 9.27  (11.720) 9.81  (12.524) 8.91  (12.680) 8.26  (12.835) 6.44  (12.279) 6.85  (12.118)
29.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 25 53 49 37 43 43 71 75 91 81
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 42.23  (8.073) 41.52  (8.401) 40.23  (6.713) 37.29  (8.057) 38.82  (8.231) 39.16  (8.177) 36.92  (8.023) 37.85  (8.538) 41.12  (9.029) 39.30  (7.264)
Change at Week 172 10.08  (8.996) 9.20  (8.324) 9.68  (6.804) 11.83  (8.042) 13.21  (9.194) 10.88  (7.837) 9.61  (8.461) 9.07  (7.519) 10.47  (8.921) 8.55  (8.546)
30.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 25 53 49 37 43 43 71 75 91 81
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 40.79  (12.254) 41.49  (11.015) 37.00  (10.963) 35.47  (11.757) 38.77  (10.268) 39.83  (12.249) 36.64  (11.938) 39.01  (12.258) 40.98  (11.479) 38.85  (11.972)
Change at Week 172 7.43  (12.227) 10.37  (10.420) 9.57  (12.850) 12.84  (12.281) 9.12  (14.244) 8.45  (13.317) 8.78  (13.283) 7.52  (12.609) 8.66  (10.767) 7.48  (12.329)
31.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Overall Number of Participants Analyzed 16 33 29 31 27 33 19 21
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 40.72  (7.823) 40.83  (8.135) 40.52  (7.242) 35.64  (7.862) 36.65  (9.250) 39.33  (8.136) 39.53  (7.830) 38.40  (9.680)
Change at Week 196 11.82  (9.370) 9.98  (7.569) 9.31  (5.771) 12.35  (8.867) 14.10  (10.616) 11.75  (8.261) 6.94  (8.667) 9.83  (8.111)
32.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Overall Number of Participants Analyzed 16 33 29 31 27 33 19 21
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 39.46  (13.424) 42.74  (10.517) 40.40  (9.771) 36.17  (12.536) 39.07  (10.804) 37.63  (12.199) 40.11  (10.932) 40.05  (13.807)
Change at Week 196 9.37  (12.087) 9.43  (9.349) 9.79  (11.516) 12.62  (14.386) 10.05  (15.471) 9.26  (12.732) 8.59  (14.645) 9.75  (14.824)
33.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 21 38 36 32 32 31 38 45 3 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 39.99  (7.219) 40.71  (7.605) 39.33  (6.820) 37.54  (8.054) 38.32  (8.047) 40.28  (8.878) 37.95  (8.232) 37.77  (8.654) 39.17  (13.987) 38.79  (7.735)
Change at Week 248 11.22  (10.562) 9.95  (8.355) 11.43  (8.047) 11.70  (6.541) 13.88  (8.511) 9.98  (9.027) 9.32  (9.261) 10.50  (8.803) 15.98  (7.868) 9.88  (6.977)
34.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 21 38 36 32 32 31 38 45 3 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 38.00  (12.537) 41.76  (10.579) 38.01  (10.876) 34.26  (12.252) 38.06  (10.300) 38.04  (11.320) 36.41  (13.568) 36.77  (12.333) 38.65  (18.372) 31.20  (4.603)
Change at Week 248 11.99  (13.421) 6.13  (9.986) 10.41  (13.081) 12.70  (12.140) 9.84  (11.433) 10.61  (11.204) 7.37  (16.473) 10.61  (12.188) 7.64  (18.599) 15.98  (13.355)
35.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Overall Number of Participants Analyzed 7 14 13 9 8 16 4 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 36.89  (5.913) 38.84  (7.720) 39.22  (5.469) 36.56  (8.514) 34.80  (8.431) 39.97  (6.626) 41.04  (12.016) 34.80  (10.515)
Change at Week 300 12.03  (10.338) 10.58  (8.335) 11.15  (6.497) 15.47  (9.920) 14.42  (6.749) 10.69  (6.448) 9.10  (9.330) 6.41  (9.023)
36.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Overall Number of Participants Analyzed 7 14 13 9 8 16 4 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 34.53  (12.530) 43.55  (9.074) 35.77  (8.585) 33.38  (11.168) 39.40  (11.144) 35.79  (12.157) 31.35  (13.760) 46.99  (7.729)
Change at Week 300 21.86  (13.935) 4.82  (10.738) 9.82  (11.463) 13.46  (15.324) 6.31  (11.916) 14.79  (15.281) 19.87  (6.588) -3.67  (20.577)
37.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Overall Number of Participants Analyzed 1 1 3 1 2 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 35.68 [1]   (NA) 38.32 [1]   (NA) 44.36  (0.920) 31.07 [1]   (NA) 37.14  (3.711) 33.67 [1]   (NA)
Change at Week 352 17.97 [1]   (NA) 17.87 [1]   (NA) 5.06  (5.188) 24.06 [1]   (NA) 11.18  (2.116) 18.02 [1]   (NA)
[1]
SD was not calculated for 1 participant.
38.Primary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352
Hide Description The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352
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Hide Analysis Population Description
ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Overall Number of Participants Analyzed 1 1 3 1 2 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 42.19 [1]   (NA) 35.34 [1]   (NA) 32.72  (7.252) 22.18 [1]   (NA) 39.80  (14.563) 42.98 [1]   (NA)
Change at Week 352 17.40 [1]   (NA) 19.87 [1]   (NA) 14.14  (10.114) 25.04 [1]   (NA) 8.65  (7.463) 13.08 [1]   (NA)
[1]
SD was not calculated for 1 participant.
39.Primary Outcome
Title Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28
Hide Description EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 38 67 76 52 62 71 126 136 151 162
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 7.42  (1.328) 7.21  (1.354) 7.54  (1.399) 8.00  (1.559) 7.77  (1.442) 7.73  (1.434) 7.67  (1.475) 7.85  (1.525) 7.30  (1.360) 7.48  (1.420)
Change at Week 28 -1.29  (1.873) -1.03  (1.705) -1.44  (1.568) -1.65  (1.867) -1.82  (1.675) -1.46  (1.510) -0.75  (1.648) -0.90  (1.634) -0.96  (1.380) -0.69  (1.493)
40.Primary Outcome
Title Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28
Hide Description EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 38 67 75 52 62 70 125 135 149 157
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 58.4  (20.96) 62.1  (16.54) 53.5  (17.30) 51.5  (17.57) 52.2  (18.72) 52.3  (18.39) 53.2  (18.02) 51.3  (19.09) 56.4  (19.64) 55.6  (16.72)
Change at Week 28 22.7  (24.11) 20.0  (18.75) 25.1  (22.09) 23.8  (23.79) 27.6  (22.58) 23.7  (22.51) 16.8  (22.55) 19.9  (22.44) 17.1  (21.75) 13.4  (19.48)
41.Primary Outcome
Title Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52
Hide Description EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
Arm/Group Title Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Hide Arm/Group Description:
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.

In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
Overall Number of Participants Analyzed 32 65 70 48 56 63 107 118 133 135
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 7.50  (1.368) 7.17  (1.318) 7.54  (1.390) 8.08  (1.499) 7.75  (1.468) 7.65  (1.358) 7.62  (1.398) 7.74  (1.538) 7.33  (1.386) 7.49  (1.429)
Change at Week 52 -1.59  (1.775) -1.00  (1.571) -1.43  (1.556) -1.60  (1.673) -1.77  (1.640) -1.46  (1.457) -0.87  (1.666) -1.15  (1.703) -0.95  (1.551) -0.85  (1.637)
42.Primary Outcome
Title Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52
Hide Description EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time Frame Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
Hide Outcome Measure Data