Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
NCT ID: NCT00105300
Last Updated: 2006-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2004-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Adalimumab
Eligibility Criteria
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Inclusion Criteria
* Normal lab parameters
* Are willing to give informed consent
* Have previously used and either were intolerant to or lost response to infliximab
Exclusion Criteria
* Diagnosis of ulcerative colitis
* Pregnant female or breast feeding subjects
* Known obstructive strictures
* Surgical bowel resection in the past 6 months
* History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis)
* History of poorly controlled medical conditions
* Specific doses and durations of Crohn's medications
* Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab
18 Years
75 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Principal Investigators
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Global Medical Information 1-800-633-9110
Role: STUDY_DIRECTOR
Abbott
Locations
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Clinical Research Associates
Huntsville, Alabama, United States
Capitol Gastroenterology Consultants Medical Group, Inc.
Roseville, California, United States
Medical Associates Research Group
San Diego, California, United States
Sharp Rees-Stealy Medical Group
San Diego, California, United States
SMC-Trauma Research
Englewood, Colorado, United States
Clinical Research of West Florida, Inc
Clearwater, Florida, United States
V.A. Medical Center
Gainesville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Pinnacle Trials, Inc.
Atlanta, Georgia, United States
Atlanta Gastroenterology Assoc.
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Ntouch Research
Peoria, Illinois, United States
Outpatient Clinical Research Facility University of Indianapolis
Indianapolis, Indiana, United States
University of Kentucky Medical Center Division of Digestive Diseases
Lexington, Kentucky, United States
Drug Research Services, Inc.
Metairie, Louisiana, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Charm City Research
Towson, Maryland, United States
Minnesota Gastroenterology P.A.
Plymouth, Minnesota, United States
Mayo Clinic Research
Rochester, Minnesota, United States
Gastrointestinal Associated, P.A.
Jackson, Mississippi, United States
Glen Gordon, MD
Mexico, Missouri, United States
St. Louis Center for Clinical Research
St Louis, Missouri, United States
Atlantic Gastroenterology Associates, LLC
Egg Harbor, New Jersey, United States
Long Island Clinical Research Assoc. LLP
Great Neck, New York, United States
NY Center for Clinical Research
Lake Success, New York, United States
Mount Sinai School of Medicine IBD Research Center
New York, New York, United States
Asheville Gastroenterology Associates
Ashville, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Gastrointestinal and Liver Disease Consultants
Dayton, Ohio, United States
Gastroenterology Associates of Cleveland
Mayfield Heights, Ohio, United States
The Oregon Clinic, PC Gastroenterology Division
Portland, Oregon, United States
Regional Gastroenterologist Associates of Lancaster
Lancaster, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Columbia Gastro Associates
Columbia, South Carolina, United States
Gastrointestinal Associates
Knoxville, Tennessee, United States
Gastroenterology Center of the Mid South
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Austin Gastroenterology
Austin, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Internal Medicine Associates
Danville, Virginia, United States
Digestive and Liver Disease
Norfolk, Virginia, United States
Spokane Digestive Disease Center
Spokane, Washington, United States
Discovery Research International, LLC
Milwaukee, Wisconsin, United States
Imelda Ziekenhuis
Bonheiden, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
Heritage Medical Research Clinic Health Sciences Centre University of Calgary
Calgary, Alberta, Canada
Liver and Intestinal Disease Research Center
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Toronto Digestive Disease Assoc. Inc
Toronto, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Hopital Claude Claude Huriez Hospital
Lille, Cedex, France
Countries
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References
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Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel JF, Panaccione R, D'Haens G, Li J, Rosenfeld MR, Kent JD, Pollack PF. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):829-38. doi: 10.7326/0003-4819-146-12-200706190-00159. Epub 2007 Apr 30.
Other Identifiers
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M04-691
Identifier Type: -
Identifier Source: org_study_id