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

Sponsor
AbbVie
Study ID
NCT06764693
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Jan 8, 2025
Start date
Jan 31, 2025
Status verified
Feb 2026
Primary completion
Jan 31, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
1,200 participants (estimated)

Arms

  • Arm: Biologic Disease-Modifying Antirheumatic Drugs (bDMARD)
    Participants will receive bDMARDs as prescribed by their physician according to local label.
  • Arm: Risankizumab
    Participants will receive risankizumab as prescribed by their physician according to local label.

Primary Outcome Measure

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

Central Contacts

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