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Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease (GEMINI III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01224171
Recruitment Status : Completed
First Posted : October 19, 2010
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Drug: vedolizumab
Other: Placebo
Enrollment 416
Recruitment Details Participants with moderately to severely active Crohn's Disease took part in the study at 107 sites worldwide from 24 November 2010 to 12 April 2012. Approximately 75% of participants were to have previously failed tumor necrosis factor alpha (TNFα) antagonist therapy and approximately 25% were to have been naïve to TNFα antagonist therapy.
Pre-assignment Details Participants were randomized 1:1 to receive either 300 mg vedolizumab or placebo. Randomization to treatment assignment was stratified by the presence or absence of previous failure of TNFα antagonist therapy or naïve to TNFα antagonist therapy, concomitant use of oral corticosteroids and concomitant use of immunomodulators.
Arm/Group Title Placebo Vedolizumab
Hide Arm/Group Description Participants received placebo intravenous infusion at Weeks 0, 2 and 6. Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Period Title: Overall Study
Started 207 209
TNFα Antagonist Failure Population 157 [1] 158 [1]
Completed 192 [2] 196 [2]
Not Completed 15 13
Reason Not Completed
Adverse Event             8             4
Protocol Violation             0             1
Lack of Efficacy             5             1
Withdrawal of Consent             2             4
Lost to Follow-up             0             3
[1]
Previously failed (inadequate response, loss of response, or intolerance) TNFα antagonist therapy
[2]
Completed study is defined as patients who completed the Week 10 assessments.
Arm/Group Title Placebo Vedolizumab Total
Hide Arm/Group Description Participants received placebo intravenous infusion at Weeks 0, 2 and 6. Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6. Total of all reporting groups
Overall Number of Baseline Participants 207 209 416
Hide Baseline Analysis Population Description
The Overall Intent-to-treat (ITT) Population consisted of all randomized participants who received any amount of blinded study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 209 participants 416 participants
37.1  (13.15) 38.6  (12.14) 37.9  (12.66)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
< 35 years 105 88 193
≥ 35 years 102 121 223
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
< 65 years 202 206 408
≥ 65 years 5 3 8
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
Female
118
  57.0%
118
  56.5%
236
  56.7%
Male
89
  43.0%
91
  43.5%
180
  43.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
Hispanic or Latino
4
   1.9%
4
   1.9%
8
   1.9%
Not Hispanic or Latino
199
  96.1%
204
  97.6%
403
  96.9%
Unknown or Not Reported
4
   1.9%
1
   0.5%
5
   1.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
White 186 188 374
Black 5 4 9
Asian 9 9 18
Other 7 6 13
Not Reported 0 2 2
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 207 participants 209 participants 416 participants
71.3  (19.22) 69.5  (17.76) 70.4  (18.50)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 207 participants 209 participants 416 participants
24.6  (6.13) 24.0  (5.13) 24.3  (5.65)
Geographic Region  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
North America 95 102 197
Western/Northern Europe 37 38 75
Central Europe 46 41 87
Eastern Europe 15 10 25
Asia/Australia/Africa 14 18 32
Duration of Crohn's Disease (CD)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 209 participants 416 participants
10.0  (7.98) 10.6  (8.75) 10.3  (8.37)
Duration of Crohn's Disease - Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
< 1 year 12 11 23
≥ 1 to < 3 years 25 28 53
≥ 3 to < 7 years 52 52 104
≥ 7 years 118 118 236
Baseline Disease Activity – Crohn’s Disease Activity Index (CDAI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 207 participants 209 participants 416 participants
301.3  (54.97) 313.9  (53.17) 307.7  (54.38)
[1]
Measure Description: Baseline disease activity represents the baseline CDAI score. The CDAI is a numerical calculation derived from the sum of products from a list of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to ~600 points with lower scores indicating disease remission and higher scores indicating disease worsening.
Baseline Disease Activity – Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
CDAI ≤ 330 148 132 280
CDAI > 330 59 77 136
C-reactive Protein (CRP)  
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 207 participants 209 participants 416 participants
18.5  (21.98) 19.0  (23.17) 18.8  (22.56)
CRP - Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
≤ 2.87 mg/L 41 46 87
> 2.87 to ≤ 5 mg/L 19 14 33
> 5 to ≤ 10 mg/L 42 48 90
> 10 mg/L 105 101 206
Fecal Calprotectin   [1] 
Mean (Standard Deviation)
Unit of measure:  μg/g
Number Analyzed 207 participants 209 participants 416 participants
1426.5  (2357.76) 1148.1  (1878.58) 1288.0  (2134.79)
[1]
Measure Description: Number of participants for whom baseline fecal calprotectin data were available were 206 and 204, respectively.
Fecal Calprotectin - Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
≤ 250 μg/g 47 52 99
> 250 to ≤ 500 μg/g 35 35 70
> 500 μg/g 124 117 241
Missing 1 5 6
Disease Localization  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
Ileum only 29 33 62
Colon only 52 48 100
Ileocolonic (both ileum and colon) 126 128 254
History of Prior Surgery for Crohn's Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
Yes 89 92 181
No 118 117 235
Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
Current Smoker 58 65 123
Never Smoked 102 93 195
Former Smoker 47 51 98
History of Fistulizing Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
Yes 77 71 148
No 130 138 268
Draining Fistula at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
Yes 25 25 50
All Closed 0 1 1
No Fistula 182 183 365
Extraintestinal Manifestations at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 209 participants 416 participants
Yes 130 116 246
No 77 93 170
1.Primary Outcome
Title Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
Hide Description

Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.

Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
TNFα Antagonist Failure Intent-to-treat (ITT) subpopulation which consisted of all randomized participants who received any amount of blinded study drug who met the TNFα antagonist failure criterion.
Arm/Group Title Placebo Vedolizumab
Hide Arm/Group Description:
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Overall Number of Participants Analyzed 157 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.1
(7.0 to 17.2)
15.2
(9.6 to 20.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vedolizumab
Comments Clinical remission was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level with stratification according to concomitant use of oral corticosteroids and concomitant use of immunomodulators (6-mercaptopurine [6-MP], azathioprine, or methotrexate) for the TNFα antagonist failure subpopulation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4332
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-4.5 to 10.5
Estimation Comments Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo
2.Secondary Outcome
Title Percentage of Participants in Clinical Remission at Week 6 in the Overall Population
Hide Description

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.

Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Overall ITT population, consisting of all randomized participants who received any amount of blinded study drug.
Arm/Group Title Placebo Vedolizumab
Hide Arm/Group Description:
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Overall Number of Participants Analyzed 207 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.1
(7.6 to 16.5)
19.1
(13.8 to 24.5)
3.Secondary Outcome
Title Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation
Hide Description

Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.

Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
TNFα Antagonist Failure Intent-to-treat (ITT) Subpopulation
Arm/Group Title Placebo Vedolizumab
Hide Arm/Group Description:
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Overall Number of Participants Analyzed 157 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.1
(7.0 to 17.2)
26.6
(19.7 to 33.5)
4.Secondary Outcome
Title Percentage of Participants in Clinical Remission at Week 10 in the Overall Population
Hide Description

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.

Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Overall ITT population
Arm/Group Title Placebo Vedolizumab
Hide Arm/Group Description:
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Overall Number of Participants Analyzed 207 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.0
(8.5 to 17.6)
28.7
(22.6 to 34.8)
5.Secondary Outcome
Title Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population
Hide Description

Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.

Time Frame Week 6 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
TNFα Antagonist Failure ITT Subpopulation
Arm/Group Title Placebo Vedolizumab
Hide Arm/Group Description:
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Overall Number of Participants Analyzed 157 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.3
(4.0 to 12.6)
12.0
(7.0 to 17.1)
6.Secondary Outcome
Title Percentage of Participants With Sustained Clinical Remission in the Overall Population
Hide Description

Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.

Time Frame Week 6 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Overall ITT population
Arm/Group Title Placebo Vedolizumab
Hide Arm/Group Description:
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Overall Number of Participants Analyzed 207 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.2
(4.5 to 12.0)
15.3
(10.4 to 20.2)
7.Secondary Outcome
Title Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation
Hide Description

Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from Baseline.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percent deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.

Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
TNFα Antagonist Failure ITT Subpopulation
Arm/Group Title Placebo Vedolizumab
Hide Arm/Group Description:
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Overall Number of Participants Analyzed 157 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.3
(15.8 to 28.8)
39.2
(31.6 to 46.9)
8.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description

An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML).

Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?

Time Frame From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.
Hide Outcome Measure Data
Hide Analysis Population Description
Overall Safety Population
Arm/Group Title Placebo Vedolizumab
Hide Arm/Group Description:
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Overall Number of Participants Analyzed 207 209
Measure Type: Number
Unit of Measure: participants
Any adverse event 124 117
Drug-related adverse event 34 34
Adverse event resulting in study discontinuation 8 4
Serious adverse event 16 13
Serious infection adverse event 0 2
Drug-related serious adverse event 1 1
Serious adverse event resulting in discontinuation 5 4
Death 0 0
Time Frame From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Placebo Vedolizumab
Hide Arm/Group Description Participants received placebo intravenous infusion at Weeks 0, 2 and 6. Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
All-Cause Mortality
Placebo Vedolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vedolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   16/207 (7.73%)   13/209 (6.22%) 
Blood and lymphatic system disorders     
Anaemia  1  0/207 (0.00%)  1/209 (0.48%) 
Gastrointestinal disorders     
Crohn’s disease  1  11/207 (5.31%)  2/209 (0.96%) 
Abdominal pain  1  1/207 (0.48%)  1/209 (0.48%) 
Pancreatitis  1  0/207 (0.00%)  1/209 (0.48%) 
Small intestinal obstruction  1  0/207 (0.00%)  1/209 (0.48%) 
Gastric ulcer  1  0/207 (0.00%)  1/209 (0.48%) 
Gastritis  1  0/207 (0.00%)  1/209 (0.48%) 
General disorders     
General physical health deterioration  1  1/207 (0.48%)  0/209 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute  1  0/207 (0.00%)  1/209 (0.48%) 
Infections and infestations     
Anal abscess  1  0/207 (0.00%)  1/209 (0.48%) 
Urinary tract infection  1  0/207 (0.00%)  1/209 (0.48%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  0/207 (0.00%)  1/209 (0.48%) 
Dehydration  1  1/207 (0.48%)  0/209 (0.00%) 
Musculoskeletal and connective tissue disorders     
Joint effusion  1  0/207 (0.00%)  1/209 (0.48%) 
Polyarthritis  1  1/207 (0.48%)  0/209 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ependymoma  1  0/207 (0.00%)  1/209 (0.48%) 
Nervous system disorders     
Demyelination  1  1/207 (0.48%)  0/209 (0.00%) 
Skin and subcutaneous tissue disorders     
Urticaria  1  1/207 (0.48%)  0/209 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Vedolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   29/207 (14.01%)   25/209 (11.96%) 
Gastrointestinal disorders     
Nausea  1  5/207 (2.42%)  12/209 (5.74%) 
General disorders     
Pyrexia  1  13/207 (6.28%)  7/209 (3.35%) 
Nervous system disorders     
Headache  1  15/207 (7.25%)  11/209 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Millennium Pharmaceuticals Inc.
Phone: 800-778-2860
EMail: clinicaltrialregistry@tpna.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01224171     History of Changes
Other Study ID Numbers: C13011
U1111-1158-2581 ( Registry Identifier: WHO )
2009-016488-12 ( EudraCT Number )
NL34356.078.10 ( Registry Identifier: CCMO )
First Submitted: October 18, 2010
First Posted: October 19, 2010
Results First Submitted: June 19, 2014
Results First Posted: July 21, 2014
Last Update Posted: July 21, 2014