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

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.

Key facts

Study ID

NCT01224171

Run by

Millennium Pharmaceuticals, Inc.

People needed

416

Starts

2010-11-01

Expected to finish

2012-04-01

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
• Crohn's Disease 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 one conventional therapy as defined by the protocol
• 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
• 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 therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
• Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
• Active or latent tuberculosis

Where it is running

• Gastroenterology of the Rockies — Lafayette, Colorado, United States
• Gastroenterology Center of Connecticut P.C. — Hamden, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Shafran Gastroenterology Center — Winter Park, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Gastroenterology Associates of Central Georgia — Macon, Georgia, United States
• Atlanta Gastroenterology Specialist PC — Suwanee, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Cotton O'Neil Digestive Health Center — Topeka, Kansas, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• University Of Louisville — Louisville, Kentucky, United States
• Gastroenterology Associates — Baton Rouge, Louisiana, United States
• Gastroenterology Research of New Orleans — Hammond, Louisiana, United States
• Metropolitan Gastroenterology Group P.C. — Chevy Chase, Maryland, United States
• Mid-Atlantic Medical Research Center — Hollywood, Maryland, United States
• Massachusetts General Hospital Crohn's and Colitis Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Center for Digestive Health — Troy, Michigan, United States
• Huron Gastroenterology Associates — Ypsilanti, Michigan, United States
• Minnesota Gastroenterology P.A. — Plymouth, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Long Island Clinical Research Associates — Great Neck, New York, United States

Full record on ClinicalTrials.gov

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