Status:
COMPLETED
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Crohn's Disease
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 and remission at 6 weeks and to determine the effect of vedolizumab maintenance tr...
Detailed Description
Study C13007 comprised 2 randomized, double-blind, placebo-controlled studies conducted under 1 protocol which, operationally, consisted of 2 phases. * The Induction Phase, designed to establish the ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age 18 to 80
- Diagnosis of moderately to severely active Crohn's disease (CD)
- CD 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 1 of the following agents, within protocol-specified parameters:
- Immunomodulators
- Tumor necrosis factor-alpha (TNFα) antagonists
- Corticosteroids
- May be receiving a therapeutic dose of conventional therapies for irritable bowel disease (IBD) defined by the protocol
- Exclusion Criteria
- 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
- 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 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
1116 Patients enrolled
Trial Details
Trial ID
NCT00783692
Start Date
December 1 2008
End Date
May 1 2012
Last Update
July 21 2014
Active Locations (114)
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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
Gastrointestinal Bioscience
Los Angeles, California, United States, 90067
4
Paramount Medical Specialty
Montebello, California, United States, 90640