Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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 clinical remission at 52 weeks.

Key facts

Study ID

NCT00783718

Run by

Millennium Pharmaceuticals, Inc.

People needed

895

Starts

2009-01-01

Expected to finish

2012-03-01

Last updated by the study team

2014-07-18

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Apex Clinical Trials — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center — Los Angeles, California, 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
• Gastroenterology of the Rockies — Lafayette, Colorado, United States
• Rocky Mountain Gastroenterology Associates P.L.L.C. — Lakewood, 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
• 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
• 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 South Florida — Tampa, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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