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A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Phase 3
18 Years
80 Years
Not Enrolling
Crohn's Disease

Thank you

Trial Information

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Inclusion Criteria:

- 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

- May be receiving a therapeutic dose of conventional therapies for IBD as defined by
the protocol

Exclusion Criteria

- 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; HIV infection

- Active or latent tuberculosis

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Proportion of patients in clinical remission in the tumor necrosis factor alpha antagonist therapy subpopulation

Outcome Time Frame:

Week 6

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

April 2012

Related Keywords:

  • Crohn's Disease
  • Crohn Disease



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Mayo Clinic Rochester, Minnesota  55905
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
University of Washington School of Medicine Seattle, Washington  98195
Wisconsin Center for Advanced Research Milwaukee, Wisconsin  53207
University of Florida Gainesville, Florida  32610-0277
University of Rochester Rochester, New York  14642
University of Chicago Medical Center Chicago, Illinois  60637
University of Louisville Louisville, Kentucky  40202
Washington University St. Louis, Missouri  63110
Atlanta Gastroenterology Associates Atlanta, Georgia  
University of Kentucky Medical Center Lexington, Kentucky  40536-0093
New York Presbyterian Hospital New York, New York  10021
University of North Carolina at Chapel Hill Chapel Hill, North Carolina  27599
University of Virginia Health System Charlottesville, Virginia  22903
University Of Miami Miller School Of Medicine Miami, Florida  33010
Gastroenterology Clinic Of San Antonio San Antonio, Texas  78229
Options Health Research Tulsa, Oklahoma  74104
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Gastroenterology Associates of Central Georgia Macon, Georgia  31201
Cotton O'Neil Digestive Health Center Topeka, Kansas  66606
Gastroenterology Associates Baton Rouge, Louisiana  70809
Center for Digestive Health Troy, Michigan  48098
Long Island Clinical Research Associates Great Neck, New York  11021
Consultants for Clinical Research Inc. Cincinnati, Ohio  45219
The Oregon Clinic-West Hills Gastroenterology Portland, Oregon  97225
Consultants in Gastroenterology Columbia, South Carolina  29203
Digestive Health Specialists of Tyler Tyler, Texas  75701
Gastroenterology Center of Connecticut P.C. Hamden, Connecticut  65180
Atlanta Gastroenterology Specialist PC Suwanee, Georgia  30024
Gastroenterology Research of New Orleans Hammond, Louisiana  70403
Metropolitan Gastroenterology Group P.C. Chevy Chase, Maryland  20815
Mid-Atlantic Medical Research Center Hollywood, Maryland  20636
Massachusetts General Hospital Crohn's and Colitis Center Boston, Massachusetts  02114
Huron Gastroenterology Associates Ypsilanti, Michigan  48197
Minnesota Gastroenterology P.A. Plymouth, Minnesota  55446
Charlotte Gastroenterology and Hepatology P.L.L.C Charlotte, North Carolina  28207
Gastroenterology Center of the MidSouth PC Germantown, Tennessee  38138