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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

200 Participants
are grouped into 1 trial group

Locations

21
Policlinico di Bari70124, Bari Italy
ASST Spedali Civili Brescia25123, Brescia Italy
Hospital Carlo Urbani60035, Iesi Italy
ASST Grande Ospedale Metropolitano Niguarda20162, Milan Italy

Sponsors and collaborators

Janssen Research & Development, LLC

Lead sponsor