Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT00105300
- Lead Sponsor
- Abbott
- Brief Summary
The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450)
- Normal lab parameters
- Are willing to give informed consent
- Have previously used and either were intolerant to or lost response to infliximab
- History of certain types of cancer
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Induction of clinical remission (CDAI score < 150 at Week 4)
- Secondary Outcome Measures
Name Time Method Changes in IBDQ scores at Week 4 Clinical response measured as Decrease in Baseline CDAI score >= 70 points at Week 4 Decrease in Baseline CDAI score >= 100 points at Week 4
Trial Locations
- Locations (56)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
SMC-Trauma Research
🇺🇸Englewood, Colorado, United States
Gastroenterology Associates of Cleveland
🇺🇸Mayfield Heights, Ohio, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
NY Center for Clinical Research
🇺🇸Lake Success, New York, United States
Clinical Research of West Florida, Inc
🇺🇸Clearwater, Florida, United States
Glen Gordon, MD
🇺🇸Mexico, Missouri, United States
Asheville Gastroenterology Associates
🇺🇸Ashville, North Carolina, United States
Charm City Research
🇺🇸Towson, Maryland, United States
Minnesota Gastroenterology P.A.
🇺🇸Plymouth, Minnesota, United States
Winnipeg Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Austin Gastroenterology
🇺🇸Austin, Texas, United States
Drug Research Services, Inc.
🇺🇸Metairie, Louisiana, United States
Regional Gastroenterologist Associates of Lancaster
🇺🇸Lancaster, Pennsylvania, United States
Internal Medicine Associates
🇺🇸Danville, Virginia, United States
University of Kentucky Medical Center Division of Digestive Diseases
🇺🇸Lexington, Kentucky, United States
Capitol Gastroenterology Consultants Medical Group, Inc.
🇺🇸Roseville, California, United States
Long Island Clinical Research Assoc. LLP
🇺🇸Great Neck, New York, United States
St. Louis Center for Clinical Research
🇺🇸St. Louis, Missouri, United States
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Hopital Claude Claude Huriez Hospital
🇫🇷Lille, Cedex, France
Gastroenterology Center of the Mid South
🇺🇸Memphis, Tennessee, United States
Digestive and Liver Disease
🇺🇸Norfolk, Virginia, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Toronto Digestive Disease Assoc. Inc
🇨🇦Toronto, Ontario, Canada
Sharp Rees-Stealy Medical Group
🇺🇸San Diego, California, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Outpatient Clinical Research Facility University of Indianapolis
🇺🇸Indianapolis, Indiana, United States
Mayo Clinic Research
🇺🇸Rochester, Minnesota, United States
Discovery Research International, LLC
🇺🇸Milwaukee, Wisconsin, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
Mount Sinai School of Medicine IBD Research Center
🇺🇸New York, New York, United States
Gastrointestinal and Liver Disease Consultants
🇺🇸Dayton, Ohio, United States
Spokane Digestive Disease Center
🇺🇸Spokane, Washington, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
V.A. Medical Center
🇺🇸Gainesville, Florida, United States
Pinnacle Trials, Inc.
🇺🇸Atlanta, Georgia, United States
Atlanta Gastroenterology Assoc.
🇺🇸Atlanta, Georgia, United States
Gastrointestinal Associated, P.A.
🇺🇸Jackson, Mississippi, United States
Ntouch Research
🇺🇸Peoria, Illinois, United States
Atlantic Gastroenterology Associates, LLC
🇺🇸Egg Harbor Township, New Jersey, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
Heritage Medical Research Clinic Health Sciences Centre University of Calgary
🇨🇦Calgary, Alberta, Canada
Columbia Gastro Associates
🇺🇸Columbia, South Carolina, United States
Liver and Intestinal Disease Research Center
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
The Oregon Clinic, PC Gastroenterology Division
🇺🇸Portland, Oregon, United States
Gastrointestinal Associates
🇺🇸Knoxville, Tennessee, United States
Imelda Ziekenhuis
🇧🇪Bonheiden, Belgium
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada