A Study of Guselkumab in Participants With Psoriatic Arthritis (PsA) in a Real-World Setting (GURU)

Janssen (J&J Innovative Medicine)

Status: Enrolling

Conditions: Arthritis, Psoriatic

Study type: Observational

Funder types: Industry

Identifiers

NCT07220824

CNTO1959PSA4020 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess how well guselkumab works in improving symptoms of psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes red, scaly patches) using muscoloskeletal ultrasound (MSUS) in a real-world setting.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of PsA as per CASPAR classification criteria for at least six months with active PsA defined as a tender joint count (TJC) greater than or equal to (>=) 3/68 and a swollen joint count (SJC) >= 3/66 at baseline, or C-reactive protein (CRP) >=0.3 milligrams per deciliter (mg/dL) if TJC and/or SJC are less than (<) 3
• a) Total synovitis power doppler ultrasound (PDUS) score >=2 and inflammation related to power doppler (PD) signal >=2 for at least 1 affected joint of 48 joints at the baseline visit (before first Guselkumab administration), or b) Total synovitis PDUS score >=2 and inflammation related to PD signal >=1 for at least 2 affected joints of 48 joints at the baseline visit (before first Guselkumab administration)
• Start guselkumab for the indication of PsA as part of standard clinical practice at the time of enrollment into the observational study or within a maximum of two weeks after the initial baseline visit
• Participants must be biologic-naïve or previously exposed to only one biologic Disease-Modifying Antirheumatic Drugs (bDMARD) and/or apremilast/deucravacitinib
• At least one clinically involved enthesitis site, defined by SPARCC index >= 1, and one imaging-detected enthesitis site at baseline

Exclusion criteria

• Previous exposure to Guselkumab or to more than one bDMARD for any indications
• Prior treatment with Janus kinase (JAK) inhibitors
• Contraindications to Guselkumab as per the summary of product characteristics (SmPC)
• Current enrollment in other investigational study or participation in other investigational study completed from less than 30 days
• Current enrollment in an observational study with Guselkumab sponsored or managed by sponsor

Trial design

200 participants in 1 patient group

Group 1: Psoriatic Arthritis

Description:

Participants with confirmed diagnosis of psoriatic arthritis treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice, including results of ultrasound examinations, will be collected in this study. Additionally, questions will be asked from participants about their health and well-being.