Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease (GEMINI III)
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ClinicalTrials.gov Identifier: NCT01224171 |
Recruitment Status :
Completed
First Posted : October 19, 2010
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
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Sponsor:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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.
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Baseline Characteristics
Arm/Group Title | Placebo | Vedolizumab | Total | |
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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 | |
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The Overall Intent-to-treat (ITT) Population consisted of all randomized participants who received any amount of blinded study drug.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 207 participants | 209 participants | 416 participants | |
Female |
118 57.0%
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118 56.5%
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236 56.7%
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Male |
89 43.0%
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91 43.5%
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180 43.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 207 participants | 209 participants | 416 participants | |
Hispanic or Latino |
4 1.9%
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4 1.9%
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8 1.9%
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Not Hispanic or Latino |
199 96.1%
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204 97.6%
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403 96.9%
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Unknown or Not Reported |
4 1.9%
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1 0.5%
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5 1.2%
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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 |
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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 |
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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 |
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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 |
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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.
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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 |
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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 |
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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.
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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 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
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):
Responsible Party: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01224171 |
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 |