Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Completed · Phase 3

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00105300

Run by

Abbott

People needed

300

Starts

2004-10-01

Last updated by the study team

2006-08-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Clinical Research Associates — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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