Remission in Subjects With Crohn's Disease, Open Label Extension

Completed · Phase 3

Conditions studied: Crohn's Disease

In brief

The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease.

Key facts

Study ID

NCT01070303

Run by

Abbott

People needed

177

Starts

2002-08-01

Expected to finish

2008-12-01

Last updated by the study team

2011-04-11

Who can join

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

You may qualify if…

• Participant had completed the Year 1 of Study M02-433 (NCT00055497)
• Diagnosis of Crohn's disease
• Willing and able to give informed consent

You may not qualify if…

• Diagnosis of ulcerative colitis
• Pregnancy or breastfeeding
• Previous use of infliximab or other anti-TNF (tumor necrosing factor) antagonists
• Previous history of active tuberculosis or listeria infection
• Previous history of cancer other than successfully treated skin cancer

Where it is running

• Gastroenterology Associates of the East Bay — Berkeley, California, United States
• Long Beach Gastroenterology Assoc. — Long Beach, California, United States
• Sharp Rees-Stealy Medical Group — San Diego, California, United States
• Gastroenterology Assoc. of Fairfield Co. — Bridgeport, Connecticut, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Wake Research Associates — Weston, Florida, United States
• Shafran Gastroenterology Center — Winter Park, Florida, United States
• Atlanta Gastroenterology Assoc. — Atlanta, Georgia, United States
• Southeastern Digestive & Liver Disease — Savannah, Georgia, United States
• Northwest Gastroenterologists, S.C. — Arlington Heights, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Drug Research Services, Inc. — Metairie, Louisiana, United States
• LSU School of Medicine — New Orleans, Louisiana, United States
• Digestive Disorders Associates — Annapolis, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Clinical Pharmacology Study Group — Worchester, Massachusetts, United States
• Mayo Clinic and Mayo Foundation — Rochester, Minnesota, United States
• Gastroenterology and Hepatology — Kansas City, Missouri, United States
• Glenn Gordon, MD — Mexico, Missouri, United States
• Deaconess Billings Clinic Research Division — Billings, Montana, United States
• Gastroenterology Specialties, P.C. — Lincoln, Nebraska, United States
• Long Island Clinical Research Associates — Great Neck, New York, United States
• NY Center for Clinical Research — Lake Success, New York, United States
• New York Presbyterian Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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