A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
Interventional
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Proportion of patients in clinical remission
Week 6 & 52
No
Medical Monitor
Study Director
Millennium Pharmaceuticals, Inc.
United States: Food and Drug Administration
C13007
NCT00783692
December 2008
May 2012
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Mayo Clinic | Rochester, Minnesota 55905 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Boston Medical Center | Boston, Massachusetts 02118 |
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Northwest Gastroenterology Associates | Bellevue, Washington 98004 |
Wisconsin Center for Advanced Research | Milwaukee, Wisconsin 53207 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Hunter Holmes McGuire VA Medical Center | Richmond, Virginia 23249 |
University of Colorado Health Sciences Center | Denver, Colorado 80262 |
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 |
University of Florida, Jacksonville | Jacksonville, Florida 32209 |
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 |
St. Louis Center for Clinical Research | St. Louis, Missouri 63128 |
Truman Medical Center | Kansas City, Missouri 64108 |
University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
University of Virginia Health System | Charlottesville, Virginia 22903 |
Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157 |
University Of Miami Miller School Of Medicine | Miami, Florida 33010 |
University of South Florida | Tampa, Florida 33612 |
South Denver Gastroenterology | Englewood, Colorado |
Alamo Medical Research | San Antonio, Texas 78215 |
Borland-Groover Clinic | Jacksonville, Florida 32256 |
Minnesota Gastroenterology, P.A. | Plymouth, Minnesota 55446 |
Austin Gastroenterology, Pa | Austin, Texas 78705 |
Gastroenterology Clinic Of San Antonio | San Antonio, Texas 78229 |
Options Health Research | Tulsa, Oklahoma 74104 |
Gastroenterology Center of the MidSouth, PC | Germantown, Tennessee 37138 |
Internal Medicine Specialists | Orlando, Florida 32806 |
Apex Clinical Trials | Birmingham, Alabama 35234 |
Gastrointestinal Bioscience | Los Angeles, California 90067 |
Paramount Medical Specialty | Montebello, California 90640 |
Capital Gastroenterology Consultants Medical Group | Sacramento, California 95815 |
Clinical Applications Laboratories Inc. | San Diego, California 92103 |
Desta Digestive Disease Medical Center | San Diego, California 92114 |
Rocky Mountain Clinical Research, LLC | Golden, Colorado 80401 |
Gastroenterology of the Rockies | Lafayette, Colorado 80026 |
Arapahoe Gastroenterology Associates P.C. | Littleton, Colorado 80120 |
Lynn Institute of Pueblo | Pueblo, Colorado 81007 |
Connecticut Gastroenterology Institute | Bristol, Connecticut 06010 |
Gastroenterology Center of Connecticut, P.C. | Hamden, Connecticut 06518 |
East Coast Institute for Research | Jacksonville, Florida 32223 |
Center for Advanced Gastroenterology | Maitland, Florida 32751 |
Osler Clinical Research | Melbourne, Florida 32901 |
United Medical Research Institute | New Smyrna Beach, Florida 32168 |
Compass Research LLC | Orlando, Florida 32806 |
West Wind'r Research & Development, LLC | Tampa, Florida 33607 |
Shafran Gastroenterology Center | Winter Park, Florida 32789 |
Southeast Regional Research Group | Columbus, Georgia 31904 |
Atlanta Center for Gastroenterology, P.C. | Decatur, Georgia 30033 |
Gastroenterology Associates of Central Georgia | Macon, Georgia 31201 |
Digestive Research Associates | Newnan, Georgia 30263 |
St. Joseph's/Candler Health System | Savannah, Georgia 31405 |
DLW Research System | Snellville, Georgia 30039 |
Carle Clinic Association P.C. | Urbana, Illinois 58150 |
Indianapolis Gastroenterology & Hepatology, Inc.- ARC | Indianapolis, Indiana 46237 |
Iowa Digestive Disease Center | Clive, Iowa 50325 |
Digestive & Liver Consultants | Clive, Iowa 50325 |
University Of Kansas | Kansas City, Kansas 66160 |
Cotton O'Neil Digestive Health Center | Topeka, Kansas 66606 |
Gastroenterology Associates | Baton Rouge, Louisiana 70809 |
Metropolitan Gastroenterology Group, P.C. | Chevy Chase, Maryland 20815 |
Shah Associates | Prince Frederick, Maryland 20678 |
The Center for Clinical Studies | Dearborn, Michigan 48124 |
Center for Digestive Health | Troy, Michigan 48098 |
Gastroenterology Associates of Western Michigan, P.L.C. | Wyoming, Michigan 49519 |
Digestive Health Specialists | Tupelo, Mississippi 38801 |
Center for Digestive and Liver Diseases, Inc. | Mexico, Missouri 65265 |
Affiliates in Gastroenterology PA | Morristown, New Jersey 07960 |
University of Medicine and Dentistry of New Jersey-NJMS | New Brunswick, New Jersey 08903 |
The Gastroenterology Group of South Jersey | Vineland, New Jersey 08360 |
Hepatobiliary Associates of New York | Bayside, New York 11358 |
Digestive Health Physician | Cheektowaga, New York 14225 |
Long Island Clinical Research Associates | Great Neck, New York 11021 |
Long Island Gastroenterology Group, P.C. | Merrick, New York 11566 |
Present Chapman Marion Steinlauf MD PC | New York, New York 10028 |
Kim, Chung MD (Private Practice) | Pittsford, New York 14534 |
Long Island Digestive Disease Consultants | Setauket, New York 11733 |
SUNY Stony Brook University Medical Center | Stonybrook, New York 11794 |
Syracuse Gastroenterological Associates | Syracuse, New York 13210 |
Asheville Gastroenterology Associates, P.A. | Asheville, North Carolina 28801 |
Charlotte Gastroentology and Hepatology, P.L.L.C | Charlotte, North Carolina 28207 |
Northwest Piedmont Clinical Research, Inc. | Elkin, North Carolina 28621 |
Burke Research Associates | Morganton, North Carolina 28655 |
Consultants for Clinical Research Inc. | Cincinnati, Ohio 45219 |
Dayton Science Institute | Dayton, Ohio 45415 |
The Oregon Clinic-West Hills Gastroenterology | Portland, Oregon 97225 |
University of Pittsburgh Medical Center - Cancer Centers | Pittsburgh, Pennsylvania 15213 |
Medical University Of SC CAR | Charleston, South Carolina 29425 |
Consultants in Gastroenterology | Columbia, South Carolina 29203 |
Bayou City Research, Ltd. | Houston, Texas 77024 |
Gastroenterology Consultants | Houston, Texas 77034 |
Jacon Medical Research Associates | Houston, Texas 77090 |
Digestive Health Center | Pasadena, Texas 77504 |
Stone Oak Research Foundation | San Antonio, Texas 78258 |
Digestive Health Specialists of Tyler | Tyler, Texas 75701 |
Granite Peaks Gastroenterology | Sandy, Utah 84094 |
Gastroenterology Associates of Northern Virginia | Fairfax, Virginia 22031 |
Digestive and Liver Disease Specialist Ltd. | Norfolk, Virginia 23502 |
Puget Sound Medical Research | Edmonds, Washington 98026 |
Pharmaseek, LLC | Madison, Wisconsin 53717 |