A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

Study Identifier
M10-239
CT.gov Identifier
NCT00667355
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
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    15+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subject who meets the definition of Ankylosing Spondylitis based on the Modified New York Criteria, has a diagnosis of active Ankylosing Spondylitis and has had an inadequate response to or intolerance to one or more nonsteroidal anti-inflammatory drugs
    Exclusion Criteria:
    - History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV - Previously received anti-TNF therapy - Spinal surgery or joint surgery involving joints to be assessed within 2 months prior to the Screening

    Protocol Summary

    To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with

    active ankylosing spondylitis

    Study Locations

    Location
    Status
    Location
    Site Reference # / Investigator 46791
    Aichi, Japan
    Status
    Not applicable
    Location
    Site Reference # / Investigator 46789
    Fukui, Japan
    Status
    Not applicable
    Location
    Site Reference # / Investigator 46798
    Fukuoka, Japan
    Status
    Not applicable
    Location
    Site Reference # / Investigator 46799
    Fukuoka, Japan
    Status
    Not applicable
    Location
    Site Reference # / Investigator 46796
    Hiroshima, Japan
    Status
    Not applicable
    Location
    Site Reference # / Investigator 46782
    Hokkaido, Japan
    Status
    Not applicable
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