Recruiting NCT06764693

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

— Observational Psoriatic Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Psoriatic Arthritis. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Argentina, Austria, Belgium, Bulgaria, Czechia +10
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

Number of participants that show persistence in treatment until 24 months [Time frame: 24 Months]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

France · 27 centers

Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 274923 — Nice
Infirmerie Protestante De Lyon /ID# 274922 — Caluire-et-Cuire
Centre Hospitalier Universitaire Gabriel-Montpied /ID# 275399 — Clermont-Ferrand
Chu Grenoble - Hôpital Sud /ID# 275200 — Échirolles
Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz /ID# 277881 — Besançon
Centre Hospitalier D'Arras /ID# 275192 — Arras
CHU de Lille - Hôpital Salengro /ID# 274980 — Lille
Chu Montpellier /ID# 274925 — Montpellier
… and 19 more centers

Germany · 23 centers

Dr. Med. Thomas Marycz /ID# 280489 — Amberg
Klinische Forschung Im Medizinischen Versorgungalltag Gbr /ID# 276208 — Planegg
Private Practice - Dr. Dirk Wernicke /ID# 279748 — Hohen Neuendorf
Rheumatologisch Immunologisch /ID# 275832 — Templin
Deutsches Endokrinologisches Versorgungszentrum DEVZ - MVZ GdR /ID# 276484 — Frankfurt am Main
Rheumateam Lahn-Dill-Siegerland /ID# 276019 — Wetzlar
Praxis. F. Bigdeli-Wilshusen /ID# 275522 — Hanover
Rheumatologie Kassel /ID# 276311 — Kassel
… and 15 more centers

Greece · 16 centers

Olympion General Clinic /ID# 271685 — Pátrai
Athens Naval Hospital /ID# 272313 — Athens
General Hospital of Athens Ippokratio /ID# 262528 — Athens
General Hospital of Athens Laiko /ID# 272325 — Athens
General Hospital of Athens Laiko /ID# 272410 — Athens
University General Hospital Attikon /ID# 272358 — Athens
Asklipieio General Hospital of Voula /ID# 272326 — Voula
… and 9 more centers

Italy · 13 centers