The purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substance containing no medication)

Condition	Treatment or Intervention	Phase
Crohn's Disease	Drug: Adalimumab	Phase III

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

Criteria

Inclusion:

• Males and females between the ages of 18 and 75 who are diagnosed with moderate to severe Crohn's Disease defined by a CDAI score of >= 220 and <= 450, normal laboratory parameters,
• are willing and able to give informed consent, and
• are able to self-inject or have a designee or healthcare professional who can inject the study medication.

Exclusion:

• History of certain types of cancer, diagnosis of ulcerative colitis,
• female or breast feeding subjects,
• surgical bowel resection(s) with in the past 6 months,
• history of listeria,
• human immunodeficiency virus (HIV),
• central nervous system demyelinating disease or untreated TB,
• history of a poorly controlled medical condition,
• unsuccessful response to infliximab or any anti-TNF agent use in the past.

California
      UCSF San Francisco General Hospital, San Francisco,  California,  94110,  United States; Not yet recruiting
      Thornton Hospital Reumatology Division, La Jolla,  California,  92037-0943,  United States; Not yet recruiting
      Cal-West, Inc., San Francisco,  California,  94117,  United States; Recruiting
Colorado
      Western States Clinical Research, Arvada,  Colorado,  80002,  United States; Recruiting
Connecticut
      Gastroenterology Associates of Fairfield County, Bridgeport,  Connecticut,  06606,  United States; Recruiting
Florida
      Gastroenterology Consultants, Ormond Beach,  Florida,  32174,  United States; Recruiting
      Mark Lamet, MD, Hollywood,  Florida,  33021,  United States; Recruiting
      V.A. Medical Center, Gainsville,  Florida,  32608,  United States; Recruiting
      Clinical Research of West Florida, Inc., Clearwater,  Florida,  33765,  United States; Recruiting
Illinois
      Northwestern University, Chicago,  Illinois,  60611,  United States; Not yet recruiting
      The University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
      Northwest Gastroenterology, Arlington Heights,  Illinois,  60005,  United States; Recruiting
Indiana
      Indianapolis Gastroenterology Research Foundation, Indianapolis,  Indiana,  46237,  United States; Recruiting
      St. Vincent Hospital: Research Department, Indianapolis,  Indiana,  46260,  United States; Recruiting
Louisiana
      Drug Research Services, Inc., Metairie,  Louisiana,  70001,  United States; Recruiting
Maryland
      Maryland Clinical Trials, Annapolis,  Maryland,  21401,  United States; Recruiting
      Chevy Chase Clinical Research, Chevy Chase,  Maryland,  20815,  United States; Recruiting
      Capital Gastroenterology Consultants, P.A., Silver Spring,  Maryland,  20901,  United States; Recruiting
Massachusetts
      Clinical Pharmacology Study Group, Worcester,  Massachusetts,  01610,  United States; Recruiting
Minnesota
      Mayo Clinic Research, Rochester,  Minnesota,  55905-0002,  United States; Recruiting
Missouri
      Gastroenterology & Hematology, Kansas City,  Missouri,  64131,  United States; Recruiting
      Glenn Gordon, MD, Mexico,  Missouri,  65265,  United States; Recruiting
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States; Recruiting
      Washington University School, St. Louis,  Missouri,  63110,  United States; Recruiting
New York
      NY Center for Clinical Research, Lake Success,  New York,  11042,  United States; Recruiting
      Digestive Disease Associates of Rockland, Pomona,  New York,  10970,  United States; Recruiting
      Long Island Clinical Research Assoc., Great Neck,  New York,  11021,  United States; Recruiting
      Daniel Present, MD, New York,  New York,  10029,  United States; Recruiting
North Carolina
      Carolina Research Associates, Charlotte,  North Carolina,  28262,  United States; Recruiting
      Carolina Digestive Health Associates, Charlotte,  North Carolina,  28211,  United States; Recruiting
      Charlotte Gastroenterology & Hepatology, Charlotte,  North Carolina,  28207,  United States; Recruiting
      Le Bauer Research, P.A., Greensboro,  North Carolina,  27403,  United States; Recruiting
      Wilmington Gastroenterology, Wilmington,  North Carolina,  28401,  United States; Recruiting
Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Not yet recruiting
Oregon
      Westhills Gastroenterology, Portland,  Oregon,  98112,  United States; Not yet recruiting
Pennsylvania
      Altoona Center for Clinical Research, Duncansville,  Pennsylvania,  16635,  United States; Recruiting
      University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15261,  United States; Recruiting
South Carolina
      Columbia Gastro Associates, Columbia,  South Carolina,  29204,  United States; Recruiting
Tennessee
      Nashville Medical Research, Nashville,  Tennessee,  37205,  United States; Recruiting
      Gastroenterology Center of the Mid South, Memphis,  Tennessee,  38120,  United States; Recruiting
Virginia
      Gastrointestinal Specialists, Richmond,  Virginia,  23230,  United States; Recruiting
Wisconsin
      Discovery Research Inteternational, LLC, Milwaukee,  Wisconsin,  53215,  United States; Recruiting
      Wisconsin Center for Advanced Research, Milwaukee,  Wisconsin,  53215,  United States; Recruiting

Study ID Numbers:  M02-404
Record last reviewed:  May 2004
Record first received:  February 12, 2004
ClinicalTrials.gov Identifier:  NCT00077779
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09