The objective of this study is to evaluate the safety and efficacy of adalimumab 40mg every other week (eow) compared to placebo in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAID) and who may have additionally failed one or more disease-modifying anti-rheumatic drug (DMARD) therapy.

Condition	Treatment or Intervention	Phase
Ankylosing Spondylitis	Drug: Adalimumab (D2E7)	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects must be >=18y/o,
• meet Modified NY Criteria definition of AS,
• have dx of active AS based on protocol specified criteria,
• inadequate response or intolerance to >= 1 NSAID,
• be able and willing to learn to self-administer sc injections.

Exclusion Criteria:

• Active TB, listeriosis,or HepB or any hx of HepC, hx of demyelinating disease, MS, Cancer, or lymphoproliferative disease,
• Previous anti-TNF therapy,
• DMARDs (other than methotrexate, hydoxychloroquine, and sulfasalazine) or intra-articular corticosteroid joint injections within 4wks, biologic or investigational therapy within 6wks, iv antibiotics within 30 days or oral antibiotics within 14 days of study dosing.

Gretchen Behrens      973-394-5517    gretchen.behrens@abbott.com

Alabama
      Coastal Clinical Research, Inc, Mobile,  Alabama,  36608,  United States; Recruiting
      University of Alabama at Birmingham, Birmingham,  Alabama,  35924,  United States; Recruiting
California
      University of San Francisco, San Francisco,  California,  94143,  United States; Recruiting
Colorado
      Sayers, Michael, Colorado Springs,  Colorado,  80910,  United States; Recruiting
      Denver Arthritis Clinic, Denver,  Colorado,  80230,  United States; Recruiting
Idaho
      Boise Arthritis Clinic, Boise,  Idaho,  83706,  United States; Recruiting
Illinois
      Feinberg School of Medicine of Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
Indiana
      Rheumatology Associates, Indianapolis,  Indiana,  46260,  United States; Recruiting
Maine
      Portland Rheumatology Associates, Portland,  Maine,  04102,  United States; Recruiting
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21224,  United States; Recruiting
      The Center for Rheumatology & Bone Research, Wheaton,  Maryland,  20902,  United States; Recruiting
Nebraska
      Westroads Medical Group, Omaha,  Nebraska,  68114,  United States; Recruiting
New Hampshire
      Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756,  United States; Recruiting
New York
      The Center for Rheumatology, Albany,  New York,  12206,  United States; Recruiting
Oklahoma
      Lynn Health Science Institute, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
Pennsylvania
      Arthritis and Osteoporosis Center Clinical Research Center of Reading, LLC, West Reading,  Pennsylvania,  19611,  United States; Recruiting
      Altoona Center for Clinical Research, Duncansville,  Pennsylvania,  16635,  United States; Recruiting
Texas
      Arthritis Center, Presbyterian Hospital, Dallas,  Texas,  75231,  United States; Recruiting
      Houston Institute for Clinical Research, Houston,  Texas,  77074,  United States; Recruiting
      Divison of Rheumatology, The University of Texas Health Science, Houston,  Texas,  77030,  United States; Recruiting
Utah
      University of Utah School of Medicine, Salt Lake City,  Utah,  84132,  United States; Recruiting
Washington
      Seattle Rheumatology Associates, Seattle,  Washington,  98104,  United States; Recruiting

Study ID Numbers:  M03-607
Record last reviewed:  June 2004
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00085644
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-16