Study of Adalimumab in Patients With Axial Spondyloarthritis

Study Identifier
M10-791
CT.gov Identifier
NCT00939003
EudraCT Identifier
2009-010643-14
EUCTIS ID
Not available
For general inquiries, please contact

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
  • Placebo
  • Open-label Adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Adult patients with inadequate response to \>/= 1 non-steroidal anti-inflammatory drugs (NSAIDs) * Chronic back pain with onset \< 45 years of age * Magnetic resonance imaging (MRI) indicating active sacroiliitis or positive human leukocyte antigen-B27 (HLA-B27) blood test in addition to meeting spondyloarthritis clinical criteria * Negative purified protein derivative (PPD) test and chest x-ray performed at Baseline visit must be negative * Ability to administer subcutaneous injections * General good health otherwise
    Exclusion Criteria:
    * Prior anti-tumor necrosis factor (TNF) therapy * Psoriasis or psoriatic arthritis * Fulfillment of modified New York criteria for ankylosing spondylitis * Recent infection requiring treatment * Significant medical events or conditions that may put patients at risk for participation * Females who are pregnant or breast-feeding or considering becoming pregnant during the study * History of cancer, except successfully treated skin cancer * Recent history of drug or alcohol abuse

    Protocol Summary

    This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 21250
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 21249
    Colorado Springs, Colorado, United States, 80910
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 21245
    Denver, Colorado, United States, 80230
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 21246
    Wheaton, Maryland, United States, 20902
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 26582
    Duncansville, Pennsylvania, United States, 16635
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 21241
    Wyomissing, Pennsylvania, United States, 19610
    Status
    Not applicable
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