Purpose of the study is to test whether subjects who were previously in clinical remission in the M02-403 study can maintain their remission on adalimumab for a period of one year compared to placebo (an inactive substance).

Condition	Treatment or Intervention	Phase
Crohn's Disease	Drug: Adalimumab (D2E7)	Phase II

Further Study Details: 

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion:

• Subjects must have successfully completed the M02-403 to be eligible for this study
• Diagnosis of Crohn's disease
• Normal laboratory parameters
• Willing and able to give informed consent

Exclusion:

• 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

California
      Gastroenterology Associates of the East Bay, Berkeley,  California,  94705,  United States
      Sharp Rees-Stealy Medical Group, San Diego,  California,  92123,  United States
      Long Beach Gastroenterology Assoc., Long Beach,  California,  90806,  United States
Connecticut
      Gastroenterology Assoc. of Fairfield Co., Bridgeport,  Connecticut,  06606,  United States
Florida
      Wake Research Associates, Weston,  Florida,  33331,  United States
      Cleveland Clinic Florida, Weston,  Florida,  33331,  United States
      Shafran Gastroenterology Center, Winter Park,  Florida,  32789,  United States
Georgia
      Southeastern Digestive & Liver Disease, Savannah,  Georgia,  31404,  United States
      Atlanta Gastroenterology Assoc., Atlanta,  Georgia,  30342,  United States
Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States
      Northwest Gastroenterologists, S.C., Arlington Heights,  Illinois,  60005,  United States
Louisiana
      LSU School of Medicine, New Orleans,  Louisiana,  70115,  United States
      Drug Research Services, Inc., Metairie,  Louisiana,  70001,  United States
Maryland
      Digestive Disorders Associates, Annapolis,  Maryland,  21401,  United States
Massachusetts
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States
      Clinical Pharmacology Study Group, Worchester,  Massachusetts,  01610,  United States
Minnesota
      Mayo Clinic and Mayo Foundation, Rochester,  Minnesota,  55905,  United States
Missouri
      Glenn Gordon, MD, Mexico,  Missouri,  65265,  United States
Montana
      Deaconess Billings Clinic Research Division, Billings,  Montana,  59101,  United States
Nebraska
      Gastroenterology Specialties, P.C., Lincoln,  Nebraska,  68503,  United States
New York
      Daniel Present, New York,  New York,  10029,  United States
      New York Presbyterian Hospital, New York,  New York,  10021,  United States
      Rochester Institute for Digestive Diseases, Rochester,  New York,  14607,  United States
      NY Center for Clinical Research, Lake Success,  New York,  11042,  United States
      Long Island Clinical Research Associates, Great Neck,  New York,  11021,  United States
North Carolina
      UNC School of Medicine, Chapel Hill,  North Carolina,  27599,  United States
      Digestive Health Specialists, Winston Salem,  North Carolina,  27103,  United States
      Charlotte Gastroenterology and Hepatology, Charlotte,  North Carolina,  28207,  United States
Ohio
      Consultants for Clinical Research, Cincinnati,  Ohio,  45219,  United States
Oklahoma
      Oklahoma Foundation for Digestive Disease, Oklahoma City,  Oklahoma,  73104,  United States
      Research Solutions, Tulsa,  Oklahoma,  74104,  United States
Pennsylvania
      Peter Molloy, MD, Pittsburgh,  Pennsylvania,  15224,  United States
Tennessee
      Diseases of the Digestive System, Chattanooga,  Tennessee,  37421,  United States
      Nashville Medical Research Institute, Nashville,  Tennessee,  37205,  United States
Virginia
      Charlottesville Medical Research, Charlottesville,  Virginia,  22902,  United States
Washington
      Inland Empire Gastroenterology, Spokane,  Washington,  99204,  United States
      Tacoma Digestive Disease Center, Tacoma,  Washington,  98405,  United States
      Northwest Gastroenterology, Bellevue,  Washington,  98004,  United States
Wisconsin
      Wisconsin Center for Advanced Research, Milwaukee,  Wisconsin,  53207,  United States

Study ID Numbers:  M02-433
Record last reviewed:  March 2005
Last Updated:  March 10, 2005
Record first received:  March 3, 2003
ClinicalTrials.gov Identifier:  NCT00055497
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08