Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab
1 other identifier
interventional
300
4 countries
56
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 11, 2005
CompletedFirst Posted
Study publicly available on registry
March 14, 2005
CompletedAugust 15, 2006
August 1, 2006
March 11, 2005
August 13, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
Induction of clinical remission (CDAI score < 150 at Week 4)
Secondary Outcomes (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
Changes in IBDQ scores at Week 4
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (56)
Clinical Research Associates
Huntsville, Alabama, 35801, United States
Capitol Gastroenterology Consultants Medical Group, Inc.
Roseville, California, 95661, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Sharp Rees-Stealy Medical Group
San Diego, California, 92123, United States
SMC-Trauma Research
Englewood, Colorado, 80113, United States
Clinical Research of West Florida, Inc
Clearwater, Florida, 33765, United States
V.A. Medical Center
Gainesville, Florida, 32608, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Pinnacle Trials, Inc.
Atlanta, Georgia, 30329, United States
Atlanta Gastroenterology Assoc.
Atlanta, Georgia, 30342, United States
The University of Chicago
Chicago, Illinois, 60673, United States
Ntouch Research
Peoria, Illinois, 60602, United States
Outpatient Clinical Research Facility University of Indianapolis
Indianapolis, Indiana, 462025250, United States
University of Kentucky Medical Center Division of Digestive Diseases
Lexington, Kentucky, 40536, United States
Drug Research Services, Inc.
Metairie, Louisiana, 70001, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Charm City Research
Towson, Maryland, 21204, United States
Minnesota Gastroenterology P.A.
Plymouth, Minnesota, 55446, United States
Mayo Clinic Research
Rochester, Minnesota, 559050002, United States
Gastrointestinal Associated, P.A.
Jackson, Mississippi, 39202, United States
Glen Gordon, MD
Mexico, Missouri, 65265, United States
St. Louis Center for Clinical Research
St Louis, Missouri, 63128, United States
Atlantic Gastroenterology Associates, LLC
Egg Harbor, New Jersey, 08234, United States
Long Island Clinical Research Assoc. LLP
Great Neck, New York, 11021, United States
NY Center for Clinical Research
Lake Success, New York, 11042, United States
Mount Sinai School of Medicine IBD Research Center
New York, New York, 10029, United States
Asheville Gastroenterology Associates
Ashville, North Carolina, 28801, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Gastrointestinal and Liver Disease Consultants
Dayton, Ohio, 45440, United States
Gastroenterology Associates of Cleveland
Mayfield Heights, Ohio, 44124, United States
The Oregon Clinic, PC Gastroenterology Division
Portland, Oregon, 97220, United States
Regional Gastroenterologist Associates of Lancaster
Lancaster, Pennsylvania, 17604, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261, United States
Columbia Gastro Associates
Columbia, South Carolina, 29204, United States
Gastrointestinal Associates
Knoxville, Tennessee, 37909, United States
Gastroenterology Center of the Mid South
Memphis, Tennessee, 38120, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Austin Gastroenterology
Austin, Texas, 78745, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
Internal Medicine Associates
Danville, Virginia, 25451, United States
Digestive and Liver Disease
Norfolk, Virginia, 23205, United States
Spokane Digestive Disease Center
Spokane, Washington, 99204, United States
Discovery Research International, LLC
Milwaukee, Wisconsin, 53207, United States
Imelda Ziekenhuis
Bonheiden, 2820, Belgium
UZ Gasthuisberg
Leuven, Belgium
Heritage Medical Research Clinic Health Sciences Centre University of Calgary
Calgary, Alberta, T2N 4N1, Canada
Liver and Intestinal Disease Research Center
Vancouver, British Columbia, V5Z 1H2, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Toronto Digestive Disease Assoc. Inc
Toronto, Ontario, M3N 2V7, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Hopital Claude Claude Huriez Hospital
Lille, Cedex, 59037, France
Related Publications (1)
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.
PMID: 17470824DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Medical Information 1-800-633-9110
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 11, 2005
First Posted
March 14, 2005
Study Start
October 1, 2004
Last Updated
August 15, 2006
Record last verified: 2006-08