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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

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 and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

Inclusion Criteria:

1. Age 18 to 80

2. Diagnosis of moderately to severely active Crohn's disease

3. CD involvement of the ileum and/or colon

4. 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

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

Exclusion Criteria

1. Evidence of abdominal abscess at the initial screening visit

2. Extensive colonic resection, subtotal or total colectomy

3. History of >3 small bowel resections or diagnosis of short bowel syndrome

4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine

5. Have received non permitted IBD therapies within either 30 or 60 days, depending on
the medication, as stated in the protocol

6. Chronic hepatitis B or C infection

7. Active or latent tuberculosis

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Proportion of patients in clinical remission

Outcome Time Frame:

Week 6 & 52

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:

December 2008

Completion Date:

May 2012

Related Keywords:

  • Crohn's Disease
  • Crohn Disease



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
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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
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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
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Rocky Mountain Clinical Research, LLC Golden, Colorado  80401
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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
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Compass Research LLC Orlando, Florida  32806
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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
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Affiliates in Gastroenterology PA Morristown, New Jersey  07960
University of Medicine and Dentistry of New Jersey-NJMS New Brunswick, New Jersey  08903
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Hepatobiliary Associates of New York Bayside, New York  11358
Digestive Health Physician Cheektowaga, New York  14225
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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
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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