A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting

Study Identifier
P21-007
CT.gov Identifier
NCT05094128
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Axial Spondyloarthritis (axSpA)
    • Study Drug
  • Upadacitinib
    • Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Clinical diagnosis of axSpA upon physician's judgement. * Physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study. * Upadacitinib prescribed in accordance with the local label.
    Exclusion Criteria:
    * Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib). * Participants with primary fibromyalgia (upon physician´s judgement) * Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days or five half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study. * Participants who cannot be treated with upadacitinib according to the applicable local label.

    Protocol Summary

    Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain that might be difficult to distinguish from other causes of chronic back pain. Many participants report persistent pain, including back pain, which impacts disease activity and and impairs quality of life while evoking typical disease burden such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained disease control, and the association between pain and clinical/patient-reported outcomes in axSpA participants.

    Upadacitinib is being developed for the treatment of axSpA. Approximately 352 adult participants with active axSpA will be enrolled in Germany.

    Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. The overall duration of the study is approximately 52 weeks.

    There may be a higher burden for participants in this study compared to usual standard of care due to study procedures. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

    Study Locations

    Location
    Status
    Location
    ACURA Rheumazentrum Baden-Bade /ID# 249751
    Baden-Baden, Baden-Wurttemberg, Germany, 76530
    Status
    Not applicable
    Location
    Heilig, Heidelberg, DE /ID# 240492
    Heidelberg, Baden-Wurttemberg, Germany, 69120
    Status
    Not applicable
    Location
    Rheumatologische Schwerpunktpraxis /ID# 245392
    Stuttgart, Baden-Wurttemberg, Germany, 70372
    Status
    Not applicable
    Location
    Praxis Dr. Haas /ID# 242982
    Tübingen, Baden-Wurttemberg, Germany, 72072
    Status
    Not applicable
    Location
    Praxis Dr. Rinaldi /ID# 242984
    Ulm, Baden-Wurttemberg, Germany, 89073
    Status
    Not applicable
    Location
    Praxis K. Pagel /ID# 240490
    Hoppegarten, Brandenburg, Germany, 15366
    Status
    Not applicable
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