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

AbbVie

Status: Enrolling

Conditions: Psoriatic Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT06764693

P24-390

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

1,200 participants in 2 patient groups

Risankizumab

Description:

Participants will receive risankizumab as prescribed by their physician according to local label.

Biologic Disease-Modifying Antirheumatic Drugs (bDMARD)

Description:

Participants will receive bDMARDs as prescribed by their physician according to local label.