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

Recruiting now

Conditions studied: Arthritis, Psoriatic

In brief

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.

Key facts

Study ID

NCT07220824

Run by

Janssen Research & Development, LLC

People needed

200

Starts

2025-12-04

Expected to finish

2028-06-30

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Azienda Ospedaliera Universitaria Integrata Verona — Verona, Italy (enrolling)
• ASST Spedali Civili Brescia — Brescia, Italy (enrolling)
• Hospital Carlo Urbani — Iesi, Italy (enrolling)
• IRCCS Ospedale Galeazzi Sant Ambrogio — Milan, Italy (enrolling)
• Istituto Ortopedico Gaetano Pini — Milan, Italy (enrolling)
• San Raffaele Hospital — Milan, Italy (enrolling)
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (enrolling)
• Azienda Ospedaliera Universitaria Federico II — Naples, Italy (enrolling)
• Seconda Univesità degli Studi di Napoli, AOU — Naples, Italy (enrolling)
• Policlinico di Bari — Bari, Italy (enrolling)
• Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (enrolling)
• Universita degli Studi di Perugia — Perugia, Italy (enrolling)
• Ospedale Santa Chiara AO Universitaria Pisana — Pisa, Italy (enrolling)
• Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale — Potenza, Italy (enrolling)
• Arcispedale Santa Maria Nuova - IRCCS — Reggio Emilia, Italy (enrolling)
• Policlinico Di Tor Vergata — Roma, Italy (enrolling)
• Fondazione Policlinico Universitario A Gemelli IRCCS — Roma, Italy (enrolling)
• A O Universitaria Senese Ospedale Santa Maria alle Scotte — Siena, Italy (enrolling)
• AO Ordine Mauriziano — Torino, Italy (enrolling)
• ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi — Varese, Italy (enrolling)
• Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone — Palermo, Italy

Full record on ClinicalTrials.gov

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