Study to Assess Change in Disease Activity and Adverse Events of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan

Study Identifier
P22-963
CT.gov Identifier
NCT05609643
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Axial Spondyloarthritis (axSpA)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant with clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York Criteria for AS. * Participant who is administered the first dose of Rinvoq for AS.
    Exclusion Criteria:
    * Participant with prior treatment by JAK inhibitors. * Participant currently participating in another clinical study except non-interventional study. * Participant for whom upadacitinib is contraindicated. * Participants who are not registered within 14 days after initiation of Rinvoq treatment for AS.

    Protocol Summary

    Axial spondyloarthritis (axSpA), which encompasses radiographic axSpA (r-axSpA, also known as ankylosing spondylitis \[AS\]) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. This study will assess how effective Rinvoq is in treating axSpA.

    Rinvoq is an approved drug for treating axSpA. Approximately 100 adult participants who are prescribed Rinvoq by their physician in accordance with local label will be enrolled in Japan.

    Participants will receive Rinvoq as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks.

    There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

    Study Locations

    Location
    Status
    Location
    Kurotsuchi Orthopaedic Clinic /ID# 251076
    Kasugashi, Aichi-ken, Japan, 8160849
    Status
    Not applicable
    Location
    Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 258201
    Nagoya, Aichi-ken, Japan, 455-8530
    Status
    Not applicable
    Location
    Nagoya University Hospital /ID# 254435
    Nagoya, Aichi-ken, Japan, 466-8560
    Status
    Not applicable
    Location
    Fujita Health University Hospital /ID# 258204
    Toyoake, Aichi-ken, Japan, 470-1192
    Status
    Not applicable
    Location
    Tomita Clinic /ID# 251075
    Kashiwa-shi, Chiba, Japan, 277-0005
    Status
    Not applicable
    Location
    Noda Hospital /ID# 254429
    Noda, Chiba, Japan, 270-0237
    Status
    Not applicable
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