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RECRUITINGOBSERVATIONAL

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

Prospective Multi-country, Real-world, Multi-arm Study of Treatment PErsistence With RISankizumab in Psoriatic Arthritis (PERIS)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: \- Participants demonstrated an inadequate response to three or more bDMARDs/targeted synthetic DMARDs (tsDMARDs). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Locations (20)

Cer Instituto Médico /ID# 274445
Quilmes, Buenos Aires, Argentina
Instituto Medico de Alta Complejidad San Isidro S.A. /ID# 274417
San Isidro, Buenos Aires, Argentina
Instituto Médico Río Cuarto /ID# 274421
Río Cuarto, Córdoba Province, Argentina
Landesklinikum Stockerau /ID# 275618
Stockerau, Lower Austria, Austria
Medizinische Universitaet Graz /ID# 273765
Graz, Styria, Austria
Krankenhaus Der Barmherzigen Brueder Graz /ID# 273764
Graz, Styria, Austria
Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 275617
Vienna, Vienna, Austria
Universite Libre de Bruxelles - Hopital Erasme /ID# 272763
Anderlecht, Brussels Capital, Belgium
Rhumaconsult Sprl /ID# 272797
Charleroi, Hainaut, Belgium
Reumacentrum Genk - Medisch Centrum Genk /ID# 272796
Genk, Limburg, Belgium
ReumaClinic /ID# 272782
Genk, Limburg, Belgium
OLV Ziekenhuis Aalst /ID# 274456
Aalst, Oost-Vlaanderen, Belgium
UZ Leuven /ID# 272781
Leuven, Vlaams-Brabant, Belgium
CHU de Liege /ID# 272784
Liège, Belgium
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 275952
Sofiya, Sofia, Bulgaria
Military Hospital - Pleven /ID# 276054
Pleven, Bulgaria
Medical Center Epiona /ID# 276037
Plovdiv, Bulgaria
University Multiprofile Hospital For Active Treatment Pulmed /ID# 276157
Plovdiv, Bulgaria
Dr. Tsvetanka Petranova ELIMED - 2 /ID# 276158
Sofia, Bulgaria
Medical Center Academy /ID# 276041
Sofia, Bulgaria