Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

Study Identifier
M03-607
CT.gov Identifier
NCT00085644
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Axial Spondyloarthritis (axSpA)
    • Study Drug
  • adalimumab (D2E7)
  • placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subjects must be >= 18 years of age - meet Modified NY Criteria definition of ankylosing spondylitis (AS) - have diagnosis of active AS based on protocol specified criteria - inadequate response or intolerance to >= 1 nonsteroidal antiinflammatory drug (NSAID) - be able and willing to learn to self-administer subcutaneous (SC) injections
    Exclusion Criteria:
    - Active tuberculosis, listeriosis,or hepatitis B, or any history of hepatitis C - History of demyelinating disease, multiple sclerosis, cancer, or lymphoproliferative disease - Previous anti-tumor necrosis factor therapy - Treatment with disease-modifying antirheumatic drugs (DMARDs - other than methotrexate, hydroxychloroquine, and sulfasalazine) - Treatment with intra-articular corticosteroid joint injections within 4 weeks of study dosing - Biologic or investigational therapy within 6 weeks of study dosing - Treatment with intravenous (IV) antibiotics within 30 days of study dosing - Treatment with oral antibiotics within 14 days of study dosing

    Protocol Summary

    The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given

    every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an

    inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal

    anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1

    disease-modifying antirheumatic drug (DMARD).

    Study Locations

    Location
    Status
    Location
    Birmingham, Alabama, United States, 35924
    Status
    Not applicable
    Location
    Mobile, Alabama, United States, 36608
    Status
    Not applicable
    Location
    San Francisco, California, United States, 94143
    Status
    Not applicable
    Location
    Colorado Springs, Colorado, United States, 80910
    Status
    Not applicable
    Location
    Denver, Colorado, United States, 80230
    Status
    Not applicable
    Location
    Boise, Idaho, United States, 83706
    Status
    Not applicable
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