Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease (GEMINI II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00783692
First received: October 31, 2008
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active CD comprises two phases:

  • The Induction Phase, designed to establish the efficacy and safety of vedolizumab (MLN0002) for the induction of clinical response and remission
  • The Maintenance Phase, designed to establish the efficacy and safety of vedolizumab(MLN0002) for the maintenance of clinical response and remission.

Condition Intervention Phase
Crohn's Disease
Drug: vedolizumab
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Proportion of patients in clinical remission [ Time Frame: Week 6 & 52 ] [ Designated as safety issue: No ]
  • Proportion of patients with enhanced clinical response [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]
    A greater than or equal to 100-point decrease in Crohn's Disease Activity Index (CDAI) score from baseline (Week 0)


Secondary Outcome Measures:
  • Proportion of patients with enhanced clinical response [ Time Frame: Week 6 & 52 ] [ Designated as safety issue: No ]

Enrollment: 1116
Study Start Date: December 2008
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
  • 1 arm for Induction Phase
  • 2 arms for Maintenance Phase
Drug: vedolizumab
Vedolizumab (MLN0002) is given at weeks 0, 2, 6 and then at 4-week intervals, or 8-week intervals for up to one year.
Other Name: MLN0002
Placebo Comparator: 2

Placebo add-on Comparator

  • 1 arm for Induction Phase
  • 1 arm for Maintenance Phase
Other: Placebo
The placebo infusion (IV) will be composed of normal saline. This is given at weeks 0, 2, 6 and then at 4-weekly intervals for up to one year.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 protocol
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783692

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Apex Clinical Trials
Birmingham, Alabama, United States, 35234
United States, California
Gastrointestinal Bioscience
Los Angeles, California, United States, 90067
Paramount Medical Specialty
Montebello, California, United States, 90640
Capital Gastroenterology Consultants Medical Group
Sacramento, California, United States, 95815
Clinical Applications Laboratories Inc.
San Diego, California, United States, 92103
Desta Digestive Disease Medical Center
San Diego, California, United States, 92114
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
Rocky Mountain Clinical Research, LLC
Golden, Colorado, United States, 80401
Gastroenterology of the Rockies
Lafayette, Colorado, United States, 80026
Arapahoe Gastroenterology Associates P.C.
Littleton, Colorado, United States, 80120
South Denver Gastroenterology
Lone Tree, Colorado, United States, 80124
Lynn Institute of Pueblo
Pueblo, Colorado, United States, 81007
United States, Connecticut
Connecticut Gastroenterology Institute
Bristol, Connecticut, United States, 06010
Gastroenterology Center of Connecticut, P.C.
Hamden, Connecticut, United States, 06518
United States, Florida
University of Florida
Gainesville, Florida, United States, 32608
University of Florida, Jacksonville
Jacksonville, Florida, United States, 32209
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
East Coast Institute for Research
Jacksonville, Florida, United States, 32223
Center for Advanced Gastroenterology
Maitland, Florida, United States, 32751
Osler Clinical Research
Melbourne, Florida, United States, 32901
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
United Medical Research Institute
New Smyrna Beach, Florida, United States, 32168
Internal Medicine Specialists
Orlando, Florida, United States, 32806
Compass Research LLC
Orlando, Florida, United States, 32806
West Wind'r Research & Development, LLC
Tampa, Florida, United States, 33607
University of South Florida
Tampa, Florida, United States, 33606
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
Southeast Regional Research Group
Columbus, Georgia, United States, 31904
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, United States, 30033
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States, 31201
Digestive Research Associates
Newnan, Georgia, United States, 30263
St. Joseph's/Candler Health System
Savannah, Georgia, United States, 31405
DLW Research System
Snellville, Georgia, United States, 30039
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Carle Clinic Association P.C.
Urbana, Illinois, United States, 58150
United States, Indiana
Indianapolis Gastroenterology & Hepatology, Inc.- ARC
Indianapolis, Indiana, United States, 46237
United States, Iowa
Iowa Digestive Disease Center
Clive, Iowa, United States, 50325
Digestive & Liver Consultants
Clive, Iowa, United States, 50325
United States, Kansas
University Of Kansas
Kansas City, Kansas, United States, 66160
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States, 66606
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
University Of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Gastroenterology Associates
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Metropolitan Gastroenterology Group, P.C.
Chevy Chase, Maryland, United States, 20815
Shah Associates
Prince Frederick, Maryland, United States, 20678
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
The Center for Clinical Studies
Dearborn, Michigan, United States, 48124
Center for Digestive Health
Troy, Michigan, United States, 48098
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, United States, 49519
United States, Minnesota
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, United States, 55486
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
Digestive Health Specialists
Tupelo, Mississippi, United States, 38801
United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
Center for Digestive and Liver Diseases, Inc.
Mexico, Missouri, United States, 65265
St. Louis Center for Clinical Research
St. Louis, Missouri, United States, 63128
Washington University
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Affiliates in Gastroenterology PA
Morristown, New Jersey, United States, 07960
University of Medicine and Dentistry of New Jersey-NJMS
New Brunswick, New Jersey, United States, 08903
The Gastroenterology Group of South Jersey
Vineland, New Jersey, United States, 08360
United States, New York
Hepatobiliary Associates of New York
Bayside, New York, United States, 11358
Digestive Health Physician
Cheektowaga, New York, United States, 14225
Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
Long Island Gastroenterology Group, P.C.
Merrick, New York, United States, 11566
Present Chapman Marion Steinlauf MD PC
New York, New York, United States, 10028
New York Presbyterian Hospital
New York, New York, United States, 10021
Kim, Chung MD (Private Practice)
Pittsford, New York, United States, 14534
University of Rochester
Rochester, New York, United States, 14642
Long Island Digestive Disease Consultants
Setauket, New York, United States, 11733
SUNY Stony Brook University Medical Center
Stonybrook, New York, United States, 11794
Syracuse Gastroenterological Associates
Syracuse, New York, United States, 13210
United States, North Carolina
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States, 28801
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Charlotte Gastroentology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States, 28207
Northwest Piedmont Clinical Research, Inc.
Elkin, North Carolina, United States, 28621
Burke Research Associates
Morganton, North Carolina, United States, 28655
Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Dayton Science Institute
Dayton, Ohio, United States, 45415
United States, Oklahoma
Options Health Research
Tulsa, Oklahoma, United States, 74104
United States, Oregon
The Oregon Clinic-West Hills Gastroenterology
Portland, Oregon, United States, 97225
United States, Pennsylvania
University of Pittsburgh Medical Center - Cancer Centers
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University Of SC CAR
Charleston, South Carolina, United States, 29425
Consultants in Gastroenterology
Columbia, South Carolina, United States, 29203
United States, Tennessee
Gastroenterology Center of the MidSouth, PC
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Austin Gastroenterology, PA
Austin, Texas, United States, 78705
Bayou City Research, Ltd.
Houston, Texas, United States, 77024
Gastroenterology Consultants
Houston, Texas, United States, 77034
Jacon Medical Research Associates
Houston, Texas, United States, 77090
Digestive Health Center
Pasadena, Texas, United States, 77504
Gastroenterology Clinic of San Antonio
San Antonio, Texas, United States, 78229
Alamo Medical Research
San Antonio, Texas, United States, 78215
Stone Oak Research Foundation
San Antonio, Texas, United States, 78258
Digestive Health Specialists of Tyler
Tyler, Texas, United States, 75701
United States, Utah
Granite Peaks Gastroenterology
Sandy, Utah, United States, 84094
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, United States, 22031
Digestive and Liver Disease Specialist Ltd.
Norfolk, Virginia, United States, 23502
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
United States, Washington
Northwest Gastroenterology Associates
Bellevue, Washington, United States, 98004
Puget Sound Medical Research
Edmonds, Washington, United States, 98026
United States, Wisconsin
Pharmaseek, LLC
Madison, Wisconsin, United States, 53717
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
GI Research
Edmonton, Alberta, Canada, T5H4B9
Zeidler Ledcor Center-Univerisity of Alberta
Edmonton, Alberta, Canada, T6G2X8
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Puerto Rico
Pharmaseek, LLC
Ponce, Puerto Rico, 716
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided by Millennium Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00783692     History of Changes
Other Study ID Numbers: C13007
Study First Received: October 31, 2008
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 17, 2014