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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01224171 |
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Date of registration:
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18/10/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
GEMINI III |
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Scientific title:
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A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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416 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01224171 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Puerto Rico
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Millennium Pharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18 to 80
- Diagnosis of moderately to severely active Crohn's disease
- Crohn's Disease involvement of the ileum and/or colon
- Demonstrated, over the previous 5 year period, an inadequate response to, loss of
response to, or intolerance of at least one conventional therapy as defined by the
protocol
- May be receiving a therapeutic dose of conventional therapies for inflammatory bowel
disease (IBD) as defined by the protocol
Exclusion Criteria
- Evidence of abdominal abscess at the initial screening visit
- Extensive colonic resection, subtotal or total colectomy
- History of >3 small bowel resections or diagnosis of short bowel syndrome
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- Have received non permitted therapies within either 30 or 60 days, depending on the
medication, as stated in the protocol
- Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
- Active or latent tuberculosis
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: vedolizumab
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Other: Placebo
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Primary Outcome(s)
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Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFa) Antagonist Failure Subpopulation
[Time Frame: Week 6]
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Secondary Outcome(s)
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Percentage of Participants in Clinical Remission at Week 10 in the Overall Population
[Time Frame: Week 10]
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Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFa Antagonist Failure Subpopulation
[Time Frame: Baseline and Week 6]
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Percentage of Participants in Clinical Remission at Week 6 in the Overall Population
[Time Frame: Week 6]
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Number of Participants With Adverse Events (AEs)
[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.]
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Percentage of Participants With Sustained Clinical Remission in the Overall Population
[Time Frame: Week 6 and Week 10]
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Percentage of Participants With Sustained Clinical Remission in the TNFa Antagonist Failure Population
[Time Frame: Week 6 and Week 10]
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Percentage of Participants in Clinical Remission at Week 10 in the TNFa Antagonist Failure Subpopulation
[Time Frame: Week 10]
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Secondary ID(s)
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C13011
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2009-016488-12
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NL34356.078.10
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U1111-1158-2581
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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