A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT00078611
- Lead Sponsor
- Biogen
- Brief Summary
The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.
- Detailed Description
Natalizumab is a humanized monoclonal antibody currently being investigated as a potential treatment for Crohn's disease. It is believed to work by preventing white blood cells from moving from the blood stream into the bowel tissue. These cells are thought to cause damage to the bowel, leading to the symptoms of Crohn's disease. Elan Pharmaceuticals is currently sponsoring an international study evaluating the safety and efficacy of natalizumab in individuals with moderately to severely active Crohn's disease. Individuals with Crohn's disease will be randomly assigned to receive either placebo (an inactive solution) or natalizumab by intravenous infusion (this means putting it directly into a vein in the arm). There will be a one out of two chance of receiving natalizumab and a one out of two chance of receiving placebo. Participants in the study will receive several infusions of natalizumab or placebo at 4-week intervals. Eligible participants will then have the opportunity to enroll into an extension study that will allow all participants to receive natalizumab. For those patients who do not enroll into the extension study, the total participation in this study will last for approximately 22 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 462
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (75)
Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo
πΊπΈWashington, District of Columbia, United States
University of Calgary
π¨π¦Calgary, Alberta, Canada
University of Alberta
π¨π¦Edmonton, Alberta, Canada
Advanced Clinical Therapeutics
πΊπΈTucson, Arizona, United States
Harmony Clinical Research
πΊπΈOro Valley, Arizona, United States
Borland Groover Clinic
πΊπΈJacksonville, Florida, United States
Rocky Mountain Gastroenterology
πΊπΈGolden, Colorado, United States
Waterside Clinical Research Services, Inc.
πΊπΈWest Palm Beach, Florida, United States
Gastroenterology Associates
πΊπΈProvidence, Rhode Island, United States
Austin Gastroenterology, PA
πΊπΈAustin, Texas, United States
GI Research
π¨π¦Edmonton, Alberta, Canada
Health Sciences Center
π¨π¦Winnipeg, Manitoba, Canada
Queen Elizabeth II Science Center
π¨π¦Halifax, Nova Scotia, Canada
Sunnybrook & Women's College Health Sciences Center
π¨π¦Toronto, Ontario, Canada
Mount Sinai Hospital
π¨π¦Toronto, Ontario, Canada
McMaster University Medical Centre
π¨π¦Hamilton, Ontario, Canada
Montreal General Hospital
π¨π¦Montreal, Quebec, Canada
Chauq Hopital Du St. Sacrement
π¨π¦Quebec, Canada
Cedars-Sinai Medical Center
πΊπΈLos Angeles, California, United States
David Geffen School of Medicine at UCLA, Division of Digestive Diseases
πΊπΈLos Angeles, California, United States
UCSF / Mt. Zion IBD Center
πΊπΈSan Francisco, California, United States
Miami Research Associates, Inc.
πΊπΈMiami, Florida, United States
University of Chicago Hospitals
πΊπΈChicago, Illinois, United States
Indianapolis Gastroenterology Research Foundation
πΊπΈIndianapolis, Indiana, United States
Oklahoma Foundation for Digestive Research
πΊπΈOklahoma City, Oklahoma, United States
Lynn Health Science Institute
πΊπΈOklahoma City, Oklahoma, United States
Allegheny Center for Digestive Health
πΊπΈPittsburgh, Pennsylvania, United States
Nashville Medical Research Institute
πΊπΈNashville, Tennessee, United States
Atilla Ertan, MD, PA
πΊπΈHouston, Texas, United States
Gastroenterology Clinic of San Antonio, P.A.
πΊπΈSan Antonio, Texas, United States
Wasatch Clinical Research
πΊπΈSalt Lake City, Utah, United States
Virginia Mason Medical Center
πΊπΈSeattle, Washington, United States
Digestive Diseases Foundation
πΊπΈLos Angeles, California, United States
Atlanta Gastroenterology Associates
πΊπΈAtlanta, Georgia, United States
Arapahoe Gastroenterology
πΊπΈLIttleton, Colorado, United States
Center for Medical Research, LLC
πΊπΈManchester, Connecticut, United States
Advanced Clinical Research Institute
πΊπΈAnaheim, California, United States
Lynn Institute of the Rockies
πΊπΈColorado Springs, Colorado, United States
Long Island Clinical Research Associates, LLP
πΊπΈGreat Neck, New York, United States
Cleveland Clinic Foundation
πΊπΈCleveland, Ohio, United States
Drug Research Service, Inc.
πΊπΈMetairie, Louisiana, United States
Minnesota Gastroenterology, P.A.
πΊπΈPlymouth, Minnesota, United States
New York Center for Clinical Research
πΊπΈLake Success, New York, United States
Rochester Institute for Digestive Diseases and Sciences, Inc.
πΊπΈRochester, New York, United States
Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research
πΊπΈChevy Chase, Maryland, United States
Shafran Gastroenterology Center
πΊπΈWinterpark, Florida, United States
Charlotte Gastroenterology & Hepatology, PLLC.
πΊπΈCharlotte, North Carolina, United States
Asheville Gastroenterology Associates
πΊπΈAsheville, North Carolina, United States
Mount Sinai School of Medicine
πΊπΈNew York, New York, United States
Oklahoma Gastroenterology Associates
πΊπΈTulsa, Oklahoma, United States
Southeastern Clinical Research
πΊπΈChattanooga, Tennessee, United States
Gastroenterology Center of the Midsouth, P.C.
πΊπΈMemphis, Tennessee, United States
Summit Research Solutions
πΊπΈMemphis, Tennessee, United States
UVA Health System
πΊπΈCharlottesville, Virginia, United States
Gastroenterology Associates of Tidewater
πΊπΈChesapeake, Virginia, United States
McGuire DVAMC GI (111N)
πΊπΈRichmond, Virginia, United States
Tacoma Digestive Disease Research Center
πΊπΈTacoma, Washington, United States
Liver and Intestinal Research Centre
π¨π¦Vancouver, British Columbia, Canada
St. Paul's Hospital
π¨π¦Vancouver, British Columbia, Canada
Community Clinical Trials
πΊπΈOrange, California, United States
Shared Medical Research Foundation
πΊπΈTarzana, California, United States
Outpatient Clinical Research Facility
πΊπΈIndianapolis, Indiana, United States
University of Kentucky Medical Center
πΊπΈLexington, Kentucky, United States
Consultants for Clinical Research, Inc.
πΊπΈCincinnati, Ohio, United States
Milton S. Hershey Medical Center
πΊπΈHershey, Pennsylvania, United States
Malcolm Randall VA Medical Center
πΊπΈGainesville, Florida, United States
Internal Medicine Associates
πΊπΈDanville, Virginia, United States
Wake Research Associates
πΊπΈRaleigh, North Carolina, United States
University of Louisville
πΊπΈLouisville, Kentucky, United States
Wake Forest University School of Medicine
πΊπΈWinston-Salem, North Carolina, United States
Mayo Clinic
πΊπΈRochester, Minnesota, United States
University of North Carolina
πΊπΈChapel Hill, North Carolina, United States
Medical University of South Carolina - Digestive Disease Center
πΊπΈCharleston, South Carolina, United States
Aurora Helath Care
πΊπΈMilwaukee, Wisconsin, United States
Medical College of Wisconsin
πΊπΈMilwaukee, Wisconsin, United States