RecruitingNCT07220824

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

GUselkumab for the Treatment of PsA: Effectiveness Results by Ultrasound


Sponsor

Janssen Research & Development, LLC

Enrollment

200 participants

Start Date

Dec 4, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Locations(20)

Policlinico di Bari

Bari, Italy

ASST Spedali Civili Brescia

Brescia, Italy

Hospital Carlo Urbani

Iesi, Italy

IRCCS Ospedale Galeazzi Sant Ambrogio

Milan, Italy

Istituto Ortopedico Gaetano Pini

Milan, Italy

San Raffaele Hospital

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

Seconda Univesità degli Studi di Napoli, AOU

Naples, Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Universita degli Studi di Perugia

Perugia, Italy

Ospedale Santa Chiara AO Universitaria Pisana

Pisa, Italy

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, Italy

Policlinico Di Tor Vergata

Roma, Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, Italy

A O Universitaria Senese Ospedale Santa Maria alle Scotte

Siena, Italy

AO Ordine Mauriziano

Torino, Italy

ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi

Varese, Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

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NCT07220824


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