A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
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
1 other identifier
interventional
462
2 countries
75
Brief Summary
The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2004
Shorter than P25 for phase_3
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2004
CompletedStudy Start
First participant enrolled
March 1, 2004
CompletedFirst Posted
Study publicly available on registry
March 8, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedJune 16, 2016
March 1, 2012
1 year
March 1, 2004
June 14, 2016
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Biogenlead
- Elan Pharmaceuticalscollaborator
Study Sites (75)
Harmony Clinical Research
Oro Valley, Arizona, 85739, United States
Advanced Clinical Therapeutics
Tucson, Arizona, 85712, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Digestive Diseases Foundation
Los Angeles, California, 90067, United States
David Geffen School of Medicine at UCLA, Division of Digestive Diseases
Los Angeles, California, 90092-7019, 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 D.C., 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
Outpatient Clinical Research Facility
Indianapolis, Indiana, 46202-5250, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46227, 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
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
Consultants for Clinical Research, Inc.
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Oklahoma Gastroenterology Associates
Tulsa, Oklahoma, 74104, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Allegheny Center for Digestive Health
Pittsburgh, Pennsylvania, 15212, United States
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
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
GI Research
Edmonton, Alberta, T5H 4B9, Canada
University of Alberta
Edmonton, Alberta, T6G 2C8, Canada
Liver and Intestinal Research Centre
Vancouver, British Columbia, V5Z 1H2, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Health Sciences Center
Winnipeg, Manitoba, R3A 1R9, Canada
Queen Elizabeth II Science Center
Halifax, Nova Scotia, B3H 1V7, Canada
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5, Canada
Sunnybrook & Women's College Health Sciences Center
Toronto, Ontario, M4N 3M5, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Chauq Hopital Du St. Sacrement
Québec, Quebec, G1S 4L8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2004
First Posted
March 8, 2004
Study Start
March 1, 2004
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
June 16, 2016
Record last verified: 2012-03