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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01224171
Date of registration: 18/10/2010
Prospective Registration: Yes
Primary sponsor: Millennium Pharmaceuticals, Inc.
Public title: Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease GEMINI III
Scientific title: 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
Date of first enrolment: November 2010
Target sample size: 416
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01224171
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Canada Puerto Rico United States
Contacts
Name:     Medical Monitor
Address: 
Telephone:
Email:
Affiliation:  Millennium Pharmaceuticals, Inc.
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: vedolizumab
Other: Placebo
Primary Outcome(s)
Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFa) Antagonist Failure Subpopulation [Time Frame: Week 6]
Secondary Outcome(s)
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.]
Percentage of Participants in Clinical Remission at Week 10 in the Overall Population [Time Frame: Week 10]
Percentage of Participants in Clinical Remission at Week 10 in the TNFa Antagonist Failure Subpopulation [Time Frame: Week 10]
Percentage of Participants in Clinical Remission at Week 6 in the Overall Population [Time Frame: Week 6]
Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFa Antagonist Failure Subpopulation [Time Frame: Baseline and Week 6]
Percentage of Participants With Sustained Clinical Remission in the Overall Population [Time Frame: Week 6 and Week 10]
Percentage of Participants With Sustained Clinical Remission in the TNFa Antagonist Failure Population [Time Frame: Week 6 and Week 10]
Secondary ID(s)
2009-016488-12
C13011
NL34356.078.10
U1111-1158-2581
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 21/07/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01224171
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