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

NCT ID: NCT00078611

Last Updated: 2016-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 462 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2005-03-31

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

natalizumab

Intervention Type: DRUG

Other Intervention Names

Antegren

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elan Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Harmony Clinical Research

Oro Valley, Arizona, United States

Advanced Clinical Therapeutics

Tucson, Arizona, United States

Advanced Clinical Research Institute

Anaheim, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Digestive Diseases Foundation

Los Angeles, California, United States

David Geffen School of Medicine at UCLA, Division of Digestive Diseases

Los Angeles, California, United States

Community Clinical Trials

Orange, California, United States

UCSF / Mt. Zion IBD Center

San Francisco, California, United States

Shared Medical Research Foundation

Tarzana, California, United States

Lynn Institute of the Rockies

Colorado Springs, Colorado, United States

Rocky Mountain Gastroenterology

Golden, Colorado, United States

Arapahoe Gastroenterology

Littleton, Colorado, United States

Center for Medical Research, LLC

Manchester, Connecticut, United States

Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo

Washington D.C., District of Columbia, United States

Malcolm Randall VA Medical Center

Gainesville, Florida, United States

Borland Groover Clinic

Jacksonville, Florida, United States

Miami Research Associates, Inc.

Miami, Florida, United States

Waterside Clinical Research Services, Inc.

West Palm Beach, Florida, United States

Shafran Gastroenterology Center

Winterpark, Florida, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

University of Chicago Hospitals

Chicago, Illinois, United States

Outpatient Clinical Research Facility

Indianapolis, Indiana, United States

Indianapolis Gastroenterology Research Foundation

Indianapolis, Indiana, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

University of Louisville

Louisville, Kentucky, United States

Drug Research Service, Inc.

Metairie, Louisiana, United States

Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Long Island Clinical Research Associates, LLP

Great Neck, New York, United States

New York Center for Clinical Research

Lake Success, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Rochester Institute for Digestive Diseases and Sciences, Inc.

Rochester, New York, United States

Asheville Gastroenterology Associates

Asheville, North Carolina, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Charlotte Gastroenterology & Hepatology, PLLC.

Charlotte, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Consultants for Clinical Research, Inc.

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Oklahoma Gastroenterology Associates

Tulsa, Oklahoma, United States

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Allegheny Center for Digestive Health

Pittsburgh, Pennsylvania, United States

Gastroenterology Associates

Providence, Rhode Island, United States

Medical University of South Carolina - Digestive Disease Center

Charleston, South Carolina, United States

Southeastern Clinical Research

Chattanooga, Tennessee, United States

Gastroenterology Center of the Midsouth, P.C.

Memphis, Tennessee, United States

Summit Research Solutions

Memphis, Tennessee, United States

Nashville Medical Research Institute

Nashville, Tennessee, United States

Austin Gastroenterology, PA

Austin, Texas, United States

Atilla Ertan, MD, PA

Houston, Texas, United States

Gastroenterology Clinic of San Antonio, P.A.

San Antonio, Texas, United States

Wasatch Clinical Research

Salt Lake City, Utah, United States

UVA Health System

Charlottesville, Virginia, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Internal Medicine Associates

Danville, Virginia, United States

McGuire DVAMC GI (111N)

Richmond, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Tacoma Digestive Disease Research Center

Tacoma, Washington, United States

Aurora Helath Care

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

University of Calgary

Calgary, Alberta, Canada

GI Research

Edmonton, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Liver and Intestinal Research Centre

Vancouver, British Columbia, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

Health Sciences Center

Winnipeg, Manitoba, Canada

Queen Elizabeth II Science Center

Halifax, Nova Scotia, Canada

McMaster University Medical Centre

Hamilton, Ontario, Canada

Sunnybrook & Women's College Health Sciences Center

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Montreal General Hospital

Montreal, Quebec, Canada

Chauq Hopital Du St. Sacrement

Québec, Quebec, Canada

Countries

United States; Canada

Other Identifiers

ELN100226-CD307

Identifier Type: -

Identifier Source: org_study_id