A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis (axSpA)

Study Identifier
P15-710
CT.gov Identifier
NCT03258814
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Study Details

Medical Condition
  • Axial Spondyloarthritis (axSpA)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants diagnosed with axial spondyloarthritis (axSpA) (either ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA)), fulfilling the Assessment of Spondyloarthritis International Society (ASAS) classification, aged at least 18 years * Prescription of Humira® (adalimumab) for treating axSpA according to the local product label * Eligibility for active physiotherapy according to the rheumatologist and physiotherapist * Participants must have signed written informed consent before starting any study related assessments or procedures.
    Exclusion Criteria:
    * Participants with total spinal ankylosis based on the investigators' assessments of available radiographs * Participants who are not eligible for active supervised training or active physiotherapy at the discretion of the rheumatologist and/or the physiotherapist * Participants with poorly controlled medical condition(s), which in the opinion of the investigator, would put the participant at risk by participation in the protocol * Any prior treatment with a biologic disease-modifying antirheumatic drugs (DMARD) is prohibited.

    Protocol Summary

    This study is a non-interventional, longitudinal and non-confirmatory study to compare an active supervised training (AST) with standard of care (SOC) physiotherapy in patients with axial spondyloarthritis and stable response to adalimumab (HUMIRA®) with respect to health-related outcomes. The primary objective is the improvement in spinal mobility after a 6 month training program.

    Study Locations

    Location
    Status
    Location
    Rheumahaus Studien GbR, Potsdam, DE /ID# 164494
    Potsdam, Brandenburg, Germany, 14467
    Status
    Not applicable
    Location
    MVZ Wittenbergplatz PP Orthos /ID# 204802
    Berlin, Germany, 10787
    Status
    Not applicable
    Location
    Rheumapraxis /ID# 164461
    Halle, Germany, 06128
    Status
    Not applicable
    Location
    Praxis Ortho DE /ID# 204149
    Hamburg, Germany, 22415
    Status
    Not applicable
    Location
    Praxis internistische Rheumato /ID# 164463
    Leipzig, Germany, 04129
    Status
    Not applicable
    Location
    Krankenhaus St. Josef /ID# 164501
    Wuppertal, Germany, 42105
    Status
    Not applicable