A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
1 other identifier
interventional
300
1 country
43
Brief Summary
Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
43 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
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 4, 2003
CompletedFirst Posted
Study publicly available on registry
March 6, 2003
CompletedAugust 15, 2006
August 1, 2006
March 4, 2003
August 11, 2006
Conditions
Outcome Measures
Primary Outcomes (2)
comparison of the induction of clinical remission
(achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Crohn's disease
- CDAI score at baseline of between 220 and 450
- Normal laboratory parameters
- Willing and able to give informed consent
You may not qualify if:
- Diagnosis of ulcerative colitis
- Women cannot be pregnant or breastfeeding
- No previous use of infliximab or other anti-TNF antagonists
- No previous history of tuberculosis or listeria infection
- No previous history of cancer other than successfully treated skin cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (43)
Gastroenterology Associates of the East Bay
Berkeley, California, 94705, United States
Long Beach Gastroenterology Assoc.
Long Beach, California, 90806, United States
Sharp Rees-Stealy Medical Group
San Diego, California, 92123, United States
Gastroenterology Assoc. of Fairfield Co.
Bridgeport, Connecticut, 06606, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Atlanta Gastroenterology Assoc.
Atlanta, Georgia, 30342, United States
Southeastern Digestive & Liver Disease
Savannah, Georgia, 31404, United States
Northwest Gastroenterologists, S.C.
Arlington Heights, Illinois, 600005, United States
University of Chicago
Chicago, Illinois, 60637, United States
Drug Research Services, Inc.
Metairie, Louisiana, 70001, United States
LSU School of Medicine
New Orleans, Louisiana, 70115, United States
Digestive Disorders Associates
Annapolis, Maryland, 21401, United States
Brigham and Women's Hospital
Boston, Massachusetts, 002115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Mayo Clinic and Mayo Foundation
Rochester, Minnesota, 55905, United States
Gastroenterology and Hepatology
Kansas City, Missouri, 64131, United States
Glenn Gordon, MD
Mexico, Missouri, 65265, United States
Deaconess Billings Clinic Research Division
Billings, Montana, 59101, United States
Gastroenterology Specialties, P.C.
Lincoln, Nebraska, 68503, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
NY Center for Clinical Research
Lake Success, New York, 11042, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
Daniel Present
New York, New York, 10029, United States
Rochester Institute for Digestive Diseases
Rochester, New York, 14607, United States
UNC School of Medicine
Chapel Hill, North Carolina, 27599, United States
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, 28207, United States
Carolina Research Associates
Charlotte, North Carolina, 28262, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Digestive Health Specialists
Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Oklahoma Foundation for Digestive Disease
Oklahoma City, Oklahoma, 73104, United States
Research Solutions
Tulsa, Oklahoma, 74104, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Peter Molloy, MD
Pittsburgh, Pennsylvania, 15224, United States
Diseases of the Digestive System
Chattanooga, Tennessee, 37421, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22902, United States
Northwest Gastroenterology
Bellevue, Washington, 98004, United States
Inland Empire Gastroenterology
Spokane, Washington, 99204, United States
Tacoma Digestive Disease Center
Tacoma, Washington, 98405, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53702, United States
Related Publications (1)
Steenholdt C, Al-khalaf M, Brynskov J, Bendtzen K, Thomsen OO, Ainsworth MA. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2209-17. doi: 10.1002/ibd.22910. Epub 2012 Feb 16.
PMID: 22344964DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen B Hanauer, MD
University of Chicago Department of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 4, 2003
First Posted
March 6, 2003
Study Start
April 1, 2002
Last Updated
August 15, 2006
Record last verified: 2006-08