Status:
COMPLETED
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on cli...
Detailed Description
This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active ulcerative colitis comprises two phases: * The Induction Phase, designed to est...
Eligibility Criteria
Inclusion
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Diagnosis of moderately to severely active ulcerative colitis
- Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance at least 1 of the following agents:
- Immunomodulators
- Tumor necrosis factor-alpha (TNFα) antagonists
- Corticosteroids
- May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol
Exclusion
- Evidence of abdominal abscess at the initial screening visit
- Extensive colonic resection, subtotal or total colectomy
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
- Chronic hepatitis B or C infection
- Active or latent tuberculosis
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
895 Patients enrolled
Trial Details
Trial ID
NCT00783718
Start Date
January 1 2009
End Date
March 1 2012
Last Update
July 18 2014
Active Locations (105)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Apex Clinical Trials
Birmingham, Alabama, United States, 35234
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
Gastrointestinal Bioscience
Los Angeles, California, United States, 90067