An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis
Recruiting now
Conditions studied: Psoriatic Arthritis
In brief
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.
Key facts
- Study ID
- NCT06764693
- Run by
- AbbVie
- People needed
- 1200
- Starts
- 2025-01-31
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Participants demonstrated an inadequate response to three or more bDMARDs/targeted synthetic DMARDs (tsDMARDs).
Where it is running
- Instituto Medico de Alta Complejidad San Isidro S.A. /ID# 274417 — San Isidro, Buenos Aires, Argentina (enrolling)
- Instituto Médico Río Cuarto /ID# 274421 — Río Cuarto, Córdoba Province, Argentina (enrolling)
- Landesklinikum Stockerau /ID# 275618 — Stockerau, Lower Austria, Austria (enrolling)
- Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 275617 — Vienna, State of Vienna, Austria (enrolling)
- Medizinische Universitaet Graz /ID# 273765 — Graz, Styria, Austria (enrolling)
- Krankenhaus Der Barmherzigen Brueder Graz /ID# 273764 — Graz, Styria, Austria (enrolling)
- Universite Libre de Bruxelles - Hopital Erasme /ID# 272763 — Anderlecht, Brussels Capital, Belgium (enrolling)
- Rhumaconsult Sprl /ID# 272797 — Charleroi, Hainaut, Belgium (enrolling)
- Reumacentrum Genk - Medisch Centrum Genk /ID# 272796 — Genk, Limburg, Belgium (enrolling)
- ReumaClinic /ID# 272782 — Genk, Limburg, Belgium (enrolling)
- OLV Ziekenhuis Aalst /ID# 274456 — Aalst, Oost-Vlaanderen, Belgium (enrolling)
- UZ Leuven /ID# 272781 — Leuven, Vlaams-Brabant, Belgium (enrolling)
- CHU de Liege /ID# 272784 — Liège, Belgium (enrolling)
- Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 275952 — Sofiya, Sofia, Bulgaria (enrolling)
- Military Hospital - Pleven /ID# 276054 — Pleven, Bulgaria (enrolling)
- Medical Center Epiona /ID# 276037 — Plovdiv, Bulgaria (enrolling)
- University Multiprofile Hospital For Active Treatment Pulmed /ID# 276157 — Plovdiv, Bulgaria (enrolling)
- Dr. Tsvetanka Petranova ELIMED - 2 /ID# 276158 — Sofia, Bulgaria (enrolling)
- Medical Center Academy /ID# 276041 — Sofia, Bulgaria (enrolling)
- AIPSMPR -d-r Gerganov /ID# 275953 — Varna, Bulgaria (enrolling)
- MAPO revma /ID# 272409 — Ostrava, Ostrava-mesto, Czechia (enrolling)
- Fakultni Nemocnice Plzen /ID# 276061 — Pilsen, Praha 17, Czechia (enrolling)
- Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 274923 — Nice, Alpes-Maritimes, France (enrolling)
- Infirmerie Protestante De Lyon /ID# 274922 — Caluire-et-Cuire, Auvergne-Rhône-Alpes, France (enrolling)
- Cer Instituto Médico /ID# 274445 — Quilmes, Buenos Aires, Argentina (enrolling)
Full record on ClinicalTrials.gov
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