Remission in Subjects With Crohn's Disease, 1 Year Phase (CLASSICII)
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
Inclusion: Patient must have successfully completed the induction study NCT00055523 Diagnosis of Crohn's disease Willing and able to give informed consent Exclusion: Diagnosis of ulcerative colitis Pregnancy or breastfeeding Previous use of infliximab or other anti-TNF antagonists Previous history of active tuberculosis or listeria infection Previous history of cancer other than successfully treated skin cancer
Sites / Locations
- Gastroenterology Associates of the East Bay
- Long Beach Gastroenterology Assoc.
- Sharp Rees-Stealy Medical Group
- Gastroenterology Assoc. of Fairfield Co.
- Cleveland Clinic Florida
- Wake Research Associates
- Shafran Gastroenterology Center
- Atlanta Gastroenterology Assoc.
- Southeastern Digestive & Liver Disease
- Northwest Gastroenterologists, S.C.
- University of Chicago
- Drug Research Services, Inc.
- LSU School of Medicine
- Digestive Disorders Associates
- Massachusetts General Hospital
- Brigham and Women's Hospital
- Clinical Pharmacology Study Group
- Mayo Clinic and Mayo Foundation
- Gastroenterology and Hepatology
- Glenn Gordon, MD
- Deaconess Billings Clinic Research Division
- Gastroenterology Specialties, P.C.
- Long Island Clinical Research Associates
- NY Center for Clinical Research
- New York Presbyterian Hospital
- Daniel Present
- Rochester Institute for Digestive Diseases
- UNC School of Medicine
- Charlotte Gastroenterology and Hepatology
- Carolina Research Associates
- Digestive Health Specialists
- Consultants for Clinical Research
- Oklahoma Foundation for Digestive Disease
- Research Solutions
- Altoona Center for Clinical Research
- Peter Molloy, MD
- Diseases of the Digestive System
- Nashville Medical Research Institute
- Charlottesville Medical Research
- Northwest Gastroenterology
- Inland Empire Gastroenterology
- Tacoma Digestive Disease Center
- Wisconsin Center for Advanced Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
Double-blind (DB) adalimumab placebo
Double-blind adalimumab 40 mg every other week (eow)
Double-blind adalimumab 40 mg every week (ew)
Open-label adalimumab 40 mg
Double-blind nonactive matching subcutaneous injection
Double-blind adalimumab 40 mg eow by subcutaneous injection
Double-blind adalimumab 40 mg every week by subcutaneous injection
Open-label adalimumab 40 mg eow or ew by subcutaneous injection