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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:  NCT00783692
Date of registration: 31/10/2008
Prospective Registration: Yes
Primary sponsor: Millennium Pharmaceuticals, Inc.
Public title: Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease GEMINI II
Scientific title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
Date of first enrolment: December 2008
Target sample size: 1116
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00783692
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:

1. Age 18 to 80

2. Diagnosis of moderately to severely active Crohn's disease (CD)

3. CD involvement of the ileum and/or colon

4. Demonstrated, over the previous 5 year period, an inadequate response to, loss of
response to, or intolerance of at least 1 of the following agents, within
protocol-specified parameters:

1. Immunomodulators

2. Tumor necrosis factor-alpha (TNFa) antagonists

3. Corticosteroids

5. May be receiving a therapeutic dose of conventional therapies for irritable bowel
disease (IBD) defined by the protocol

Exclusion Criteria

1. Evidence of abdominal abscess at the initial screening visit, other than a minimum of
10 aphthous ulcerations involving a minimum of 10 contiguous cm of intestine

2. Extensive colonic resection, subtotal or total colectomy

3. History of >3 small bowel resections or diagnosis of short bowel syndrome

4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine

5. Have received non permitted IBD therapies within either 30 or 60 days, depending on
the medication, as stated in the protocol

6. Chronic hepatitis B or C infection

7. 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)
Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 [Time Frame: Week 6]
Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 [Time Frame: Baseline and Week 6]
Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 [Time Frame: Week 52]
Secondary Outcome(s)
Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6 [Time Frame: Baseline and Week 6]
Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52 [Time Frame: Week 52]
Maintenance Phase: Percentage of Participants With Durable Clinical Remission [Time Frame: Assessed every 4 weeks from Week 6 to Week 50, and at Week 52]
Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52 [Time Frame: Baseline and Week 52]
Secondary ID(s)
09/H1102/65
2008-002783-33
C13007
C13007CTIL
CTRI/2009/091/000135
NL25208.096.08
NMRR-08-1047-2202
U1111-1157-7675
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/NCT00783692
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