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

Recruiting

• Conditions: Psoriatic Arthritis

• Registration Number: NCT06764693
• Lead Sponsor: AbbVie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-03
• Study First Posted: 2025-01-08
• Study Start: 2025-01-31
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-18
• Last Update Posted: 2025-07-20
• Primary Completion: 2029-02
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants that show persistence in treatment until 24 months	24 Months	Persistence over 24 months, defined as a participant who starts PsA treatment and is still on the same therapy until 24 months.

Trial Locations

Locations (92)

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, Cordoba, Argentina

Krankenhaus Der Barmherzigen Brueder Graz /ID# 273764; 🇦🇹 Graz, Steiermark, Austria

Rheuma-Zentrum Wien-Oberlaa /ID# 275617; 🇦🇹 Vienna, Wien, Austria

Universite Libre de Bruxelles - Hopital Erasme /ID# 272763; 🇧🇪 Anderlecht, Bruxelles-Capitale, Belgium

Rhumaconsult Sprl /ID# 272797; 🇧🇪 Charleroi, Hainaut, Belgium

CHU de Liège /ID# 272784; 🇧🇪 Liège, Liege, Belgium

Reumacentrum Genk - Medisch Centrum Genk /ID# 272796; 🇧🇪 Genk, Limburg, Belgium

ReumaClinic /ID# 272782; 🇧🇪 Genk, Limburg, Belgium

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