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

Information source: Elan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Antegren(TM) (natalizumab) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Elan Pharmaceuticals


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


- 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


Locations and Contacts

Chauq Hopital Du St. Sacrement, Quebec G1S 4L8, Canada

University of Calgary, Calgary, Alberta T2N 4N1, Canada

GI Research, Edmonton, Alberta T5H 4B9, Canada

University of Alberta, Edmonton, Alberta T6G 2C8, Canada

Harmony Clinical Research, Oro Valley, Arizona 85739, United States

Advanced Clinical Therapeutics, Tucson, Arizona 85712, United States

Liver and Intestinal Research Centre, Vancouver, British Columbia V5Z 1H2, Canada

St. Paul's Hospital, Vancouver, British Columbia V6Z 1Y6, Canada

Advanced Clinical Research Institute, Anaheim, California 92801, United States

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

David Geffen School of Medicine at UCLA, Division of Digestive Diseases, Los Angeles, California 90092-7019, United States

Digestive Diseases Foundation, Los Angeles, California 90067, United States

Community Clinical Trials, Orange, California 92868, United States

UCSF / Mt. Zion IBD Center, San Francisco, California 94115, United States

Shared Medical Research Foundation, Tarzana, California 91356, United States

Lynn Institute of the Rockies, Colorado Springs, Colorado 80909, United States

Rocky Mountain Gastroenterology, Golden, Colorado 80215, United States

Arapahoe Gastroenterology, LIttleton, Colorado 80120, United States

Center for Medical Research, LLC, Manchester, Connecticut 06040, United States

Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo, Washington, District of Columbia 20010, United States

Malcolm Randall VA Medical Center, Gainesville, Florida 32608, United States

Borland Groover Clinic, Jacksonville, Florida 32256, United States

Miami Research Associates, Inc., Miami, Florida 33173, United States

Waterside Clinical Research Services, Inc., West Palm Beach, Florida 33407, United States

Shafran Gastroenterology Center, Winterpark, Florida 32789, United States

Atlanta Gastroenterology Associates, Atlanta, Georgia 30342, United States

University of Chicago Hospitals, Chicago, Illinois 60637, United States

Indianapolis Gastroenterology Research Foundation, Indianapolis, Indiana 46227, United States

Outpatient Clinical Research Facility, Indianapolis, Indiana 46202-5250, United States

University of Kentucky Medical Center, Lexington, Kentucky 40536, United States

University of Louisville, Louisville, Kentucky 40202, United States

Drug Research Service, Inc., Metairie, Louisiana 70001, United States

Health Sciences Center, Winnipeg, Manitoba R3A 1R9, Canada

Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research, Chevy Chase, Maryland 20815, United States

Minnesota Gastroenterology, P.A., Plymouth, Minnesota 55446, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

Long Island Clinical Research Associates, LLP, Great Neck, New York 11021, United States

New York Center for Clinical Research, Lake Success, New York 11042, United States

Mount Sinai School of Medicine, New York, New York 10028, United States

Rochester Institute for Digestive Diseases and Sciences, Inc., Rochester, New York 14607, United States

Asheville Gastroenterology Associates, Asheville, North Carolina 28801, United States

University of North Carolina, Chapel Hill, North Carolina 27599, United States

Charlotte Gastroenterology & Hepatology, PLLC., Charlotte, North Carolina 28207, United States

Wake Research Associates, Raleigh, North Carolina 27612, United States

Wake Forest University School of Medicine, Winston-Salem, North Carolina 27012, United States

Queen Elizabeth II Science Center, Halifax, Nova Scotia B3H 1V7, Canada

Consultants for Clinical Research, Inc., Cincinnati, Ohio 45219, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

Lynn Health Science Institute, Oklahoma City, Oklahoma 73112, United States

Oklahoma Foundation for Digestive Research, Oklahoma City, Oklahoma 73104, United States

Oklahoma Gastroenterology Associates, Tulsa, Oklahoma 74104, United States

McMaster University Medical Centre, Hamilton, Ontario L8N 3Z5, Canada

Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada

Sunnybrook & Women's College Health Sciences Center, Toronto, Ontario M4N 3M5, Canada

Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States

Allegheny Center for Digestive Health, Pittsburgh, Pennsylvania 15212, United States

Montreal General Hospital, Montreal, Quebec H3G 1A4, Canada

Gastroenterology Associates, Providence, Rhode Island 02904, United States

Medical University of South Carolina - Digestive Disease Center, Charleston, South Carolina 29425, United States

Southeastern Clinical Research, Chattanooga, Tennessee 37403, United States

Gastroenterology Center of the Midsouth, P.C., Memphis, Tennessee 38120, United States

Summit Research Solutions, Memphis, Tennessee 38120, United States

Nashville Medical Research Institute, Nashville, Tennessee 37205, United States

Austin Gastroenterology, PA, Austin, Texas 78745, United States

Atilla Ertan, MD, PA, Houston, Texas 77030, United States

Gastroenterology Clinic of San Antonio, P.A., San Antonio, Texas 78229, United States

Wasatch Clinical Research, Salt Lake City, Utah 84107, United States

UVA Health System, Charlottesville, Virginia 22908, United States

Gastroenterology Associates of Tidewater, Chesapeake, Virginia 23320, United States

Internal Medicine Associates, Danville, Virginia 24541, United States

McGuire DVAMC GI (111N), Richmond, Virginia 23249, United States

Virginia Mason Medical Center, Seattle, Washington 98101, United States

Tacoma Digestive Disease Research Center, Tacoma, Washington 98405, United States

Aurora Helath Care, Milwaukee, Wisconsin 53215, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: March 2004
Last updated: March 6, 2012

Page last updated: August 23, 2015

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