An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis

Study Identifier
P24-390
CT.gov Identifier
NCT06764693
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Psoriatic Arthritis (PsA)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant with a clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening visit and fulfillment of ClASsification for Psoriatic ARthritis (CASPAR) at Baseline visit to confirm that the participant has active disease. * Participant must have demonstrated an inadequate response to at least 1 Disease-modifying antirheumatic drug (DMARD) (with max 50% Biologic DMARD-Inadequate Response); alternatively, participant must have demonstrated an intolerance to or contraindication for csDMARDs as determined by the investigator.
    Exclusion Criteria:
    \- Participants demonstrated an inadequate response to three or more bDMARDs/targeted synthetic DMARDs (tsDMARDs).

    Protocol Summary

    Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. This study aims to describe the long term usage and effectiveness with risankizumab (RZB) relative to other advanced therapeutic options for the management of PsA in daily clinical practice.

    Risankizumab is an approved drug for the treatment of psoriatic arthritis. The study will not be conducted in the United States, however it will be conducted in approximately 15 countries and include at least 900 and up to 1200 participants with a 2 to1 ratio of participant allocation between participants receiving risankizumab and participants receiving other advanced therapeutic agents.

    The therapy is prescribed in the usual manner in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. All study visits will occur during routine clinical practice and participants will be followed for 24 months.

    There is expected to be no additional burden for participants in this study.

    Study Locations

    Location
    Status
    Location
    Cer Instituto Médico /ID# 274445
    Quilmes, Buenos Aires, Argentina, 1878
    Status
    Recruiting
    Location
    Instituto Medico de Alta Complejidad San Isidro S.A. /ID# 274417
    San Isidro, Buenos Aires, Argentina, 1642
    Status
    Recruiting
    Location
    Instituto Médico Río Cuarto /ID# 274421
    Río Cuarto, Córdoba Province, Argentina, 5800
    Status
    Recruiting
    Location
    Landesklinikum Stockerau /ID# 275618
    Stockerau, Lower Austria, Austria, 2000
    Status
    Recruiting
    Location
    Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 275617
    Vienna, State of Vienna, Austria, 1100
    Status
    Recruiting
    Location
    Medizinische Universitaet Graz /ID# 273765
    Graz, Styria, Austria, 8010
    Status
    Recruiting
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