Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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 treatment on clinical remission at 52 weeks.

Key facts

Study ID

NCT00783692

Run by

Millennium Pharmaceuticals, Inc.

People needed

1116

Starts

2008-12-01

Expected to finish

2012-05-01

Last updated by the study team

2014-07-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Apex Clinical Trials — Birmingham, Alabama, United States
• Gastrointestinal Bioscience — Los Angeles, California, United States
• Paramount Medical Specialty — Montebello, California, United States
• Capital Gastroenterology Consultants Medical Group — Sacramento, California, United States
• Clinical Applications Laboratories Inc. — San Diego, California, United States
• Desta Digestive Disease Medical Center — San Diego, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Rocky Mountain Clinical Research, LLC — Golden, Colorado, United States
• Gastroenterology of the Rockies — Lafayette, Colorado, United States
• Arapahoe Gastroenterology Associates P.C. — Littleton, Colorado, United States
• South Denver Gastroenterology — Lone Tree, Colorado, United States
• Lynn Institute of Pueblo — Pueblo, Colorado, United States
• Connecticut Gastroenterology Institute — Bristol, Connecticut, United States
• Gastroenterology Center of Connecticut, P.C. — Hamden, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• University of Florida, Jacksonville — Jacksonville, Florida, United States
• East Coast Institute for Research — Jacksonville, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Center for Advanced Gastroenterology — Maitland, Florida, United States
• Osler Clinical Research — Melbourne, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• United Medical Research Institute — New Smyrna Beach, Florida, United States
• Compass Research LLC — Orlando, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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