A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00078611
Recruitment Status : Completed
First Posted : March 8, 2004
Last Update Posted : June 16, 2016
Elan Pharmaceuticals
Information provided by (Responsible Party):

Brief Summary:
The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: natalizumab Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Antegren(TM) (Natalizumab) in Subjects With Moderately to Severely Active Crohn's Disease With Elevated C-Reactive Protein
Study Start Date : March 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Natalizumab
U.S. FDA Resources

Intervention Details:
    Drug: natalizumab
    Other Name: Antegren

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Males and females 18 years of age or older
  • Diagnosis of Crohn's disease for at least 6 months
  • Females must not be pregnant or breastfeeding
  • Must not have previously taken natalizumab
  • Use of some other Crohn's disease medications is permitted, but will be closely supervised

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00078611

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United States, Arizona
Harmony Clinical Research
Oro Valley, Arizona, United States, 85739
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Digestive Diseases Foundation
Los Angeles, California, United States, 90067
David Geffen School of Medicine at UCLA, Division of Digestive Diseases
Los Angeles, California, United States, 90092-7019
Community Clinical Trials
Orange, California, United States, 92868
UCSF / Mt. Zion IBD Center
San Francisco, California, United States, 94115
Shared Medical Research Foundation
Tarzana, California, United States, 91356
United States, Colorado
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States, 80909
Rocky Mountain Gastroenterology
Golden, Colorado, United States, 80215
Arapahoe Gastroenterology
LIttleton, Colorado, United States, 80120
United States, Connecticut
Center for Medical Research, LLC
Manchester, Connecticut, United States, 06040
United States, District of Columbia
Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo
Washington, District of Columbia, United States, 20010
United States, Florida
Malcolm Randall VA Medical Center
Gainesville, Florida, United States, 32608
Borland Groover Clinic
Jacksonville, Florida, United States, 32256
Miami Research Associates, Inc.
Miami, Florida, United States, 33173
Waterside Clinical Research Services, Inc.
West Palm Beach, Florida, United States, 33407
Shafran Gastroenterology Center
Winterpark, Florida, United States, 32789
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
University of Chicago Hospitals
Chicago, Illinois, United States, 60637
United States, Indiana
Outpatient Clinical Research Facility
Indianapolis, Indiana, United States, 46202-5250
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States, 46227
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Drug Research Service, Inc.
Metairie, Louisiana, United States, 70001
United States, Maryland
Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, Minnesota
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, United States, 55446
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States, 11021
New York Center for Clinical Research
Lake Success, New York, United States, 11042
Mount Sinai School of Medicine
New York, New York, United States, 10028
Rochester Institute for Digestive Diseases and Sciences, Inc.
Rochester, New York, United States, 14607
United States, North Carolina
Asheville Gastroenterology Associates
Asheville, North Carolina, United States, 28801
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Charlotte Gastroenterology & Hepatology, PLLC.
Charlotte, North Carolina, United States, 28207
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27012
United States, Ohio
Consultants for Clinical Research, Inc.
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Oklahoma Gastroenterology Associates
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Allegheny Center for Digestive Health
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Gastroenterology Associates
Providence, Rhode Island, United States, 02904
United States, South Carolina
Medical University of South Carolina - Digestive Disease Center
Charleston, South Carolina, United States, 29425
United States, Tennessee
Southeastern Clinical Research
Chattanooga, Tennessee, United States, 37403
Gastroenterology Center of the Midsouth, P.C.
Memphis, Tennessee, United States, 38120
Summit Research Solutions
Memphis, Tennessee, United States, 38120
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37205
United States, Texas
Austin Gastroenterology, PA
Austin, Texas, United States, 78745
Atilla Ertan, MD, PA
Houston, Texas, United States, 77030
Gastroenterology Clinic of San Antonio, P.A.
San Antonio, Texas, United States, 78229
United States, Utah
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
United States, Virginia
UVA Health System
Charlottesville, Virginia, United States, 22908
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Internal Medicine Associates
Danville, Virginia, United States, 24541
McGuire DVAMC GI (111N)
Richmond, Virginia, United States, 23249
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Tacoma Digestive Disease Research Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
Aurora Helath Care
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
GI Research
Edmonton, Alberta, Canada, T5H 4B9
University of Alberta
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
Liver and Intestinal Research Centre
Vancouver, British Columbia, Canada, V5Z 1H2
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Health Sciences Center
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Queen Elizabeth II Science Center
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Sunnybrook & Women's College Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Chauq Hopital Du St. Sacrement
Quebec, Canada, G1S 4L8
Sponsors and Collaborators
Elan Pharmaceuticals

Responsible Party: Biogen Identifier: NCT00078611     History of Changes
Other Study ID Numbers: ELN100226-CD307
First Posted: March 8, 2004    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: March 2012

Keywords provided by Biogen:
Crohn's disease
Inflammatory Bowel Disease
Regional Enteritis

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunologic Factors
Physiological Effects of Drugs