Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis

Study Identifier
M03-606
CT.gov Identifier
NCT00195819
EudraCT Identifier
Not available
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 (D2E7)
  • placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subject was age 18 or older and in relatively good health (Investigator discretion) with a recent stable medical history. - Subject met the definition of AS based on the Modified New York Criteria. - Subject had an inadequate response to or intolerance to one or more NSAIDs as defined by the Investigator
    Exclusion Criteria:
    - Subject had previously received anti-TNF therapy. - Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study - Female subject who is pregnant or breast-feeding or considering becoming pregnant

    Protocol Summary

    The purpose of the study is to assess the safety and clinical efficacy of adalimumab in

    subjects with active ankylosing spondylitis

    Study Locations

    Location
    Status
    Location
    Site Ref # / Investigator 74
    Calgary, Alberta, Canada, T2N 4N1
    Status
    Not applicable
    Location
    Site Ref # / Investigator 70
    Edmonton, Alberta, Canada, T6G 2S2
    Status
    Not applicable
    Location
    Site Ref # / Investigator 79
    Vancouver, British Columbia, Canada, V5Z 1L7
    Status
    Not applicable
    Location
    Site Ref # / Investigator 64
    Winnipeg, Manitoba, Canada, R3N OK6
    Status
    Not applicable
    Location
    Site Ref # / Investigator 78
    St. John's, Newfoundland and Labrador, Canada, A1C 5B8
    Status
    Not applicable
    Location
    Site Ref # / Investigator 75
    Toronto, Ontario, Canada, M4N 3M5
    Status
    Not applicable
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