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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Proportion of patients in clinical remission in the tumor necrosis factor alpha antagonist therapy subpopulation
Week 6
No
Medical Monitor
Study Director
Millennium Pharmaceuticals, Inc.
United States: Food and Drug Administration
C13011
NCT01224171
November 2010
April 2012
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
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 |
Gastroenterology of the Rockies | Lafayette, Colorado 80026 |
Shafran Gastroenterology Center | Winter Park, Florida 32789 |
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 |