Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients

Study Identifier
P15-238
CT.gov Identifier
NCT02333383
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol and Statistical Analysis Plan
Available Language(s): English
Download document(s)
Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Axial Spondyloarthritis (axSpA)
    • Study Drug
  • Adalimumab
    • Phase
    N/A
    Sex
    Female & Male
    Age
    19 - 100 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant must be ≥19 years of age * Participant has been diagnosed with ankylosing spondylitis (AS) according to the 1984 modified New York criteria for at least 3 months * Participant has active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4, despite treatment with at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) or with disease-modifying antirheumatic drugs (DMARDs) for more than 3 months based on Korea AS reimbursement guideline * Participant is eligible for adalimumab in daily rheumatologic practice * Participant must provide written authorization form to use personal and/or health data prior to the entry into the study
    Exclusion Criteria:
    * Female participants who are pregnant or breastfeeding * Participants who are contraindicated to any anti-tumor necrosis factor (TNF) agent * Participant is enrolled in other clinical trials

    Protocol Summary

    This was a prospective mono-country, multi-center study of the frequency of extra-axial manifestations (EAMs) in Ankylosing Spondylitis (AS) participants treated with adalimumab in routine clinical practice.

    Study Locations

    No locations found.