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NCT07220824From ClinicalTrials.govRecruiting

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

  • Arthritis, Psoriatic

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Janssen Research & Development, LLC
Enrolment target
200
Started
4 December 2025
Main results due
31 July 2027
Study sites
21
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(21)

  • Policlinico di Bari

    Bari, Italy

    Recruiting

  • ASST Spedali Civili Brescia

    Brescia, Italy

    Recruiting

  • Hospital Carlo Urbani

    Iesi, Italy

    Recruiting

  • IRCCS Ospedale Galeazzi Sant Ambrogio

    Milan, Italy

    Recruiting

  • Istituto Ortopedico Gaetano Pini

    Milan, Italy

    Recruiting

  • San Raffaele Hospital

    Milan, Italy

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Italy

    Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Italy

    Recruiting

  • Seconda Univesità degli Studi di Napoli, AOU

    Naples, Italy

    Recruiting

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, Italy

    Completed

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Italy

    Recruiting

  • Universita degli Studi di Perugia

    Perugia, Italy

    Recruiting

  • Ospedale Santa Chiara AO Universitaria Pisana

    Pisa, Italy

    Recruiting

  • Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale

    Potenza, Italy

    Recruiting

  • Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, Italy

    Recruiting

  • Policlinico Di Tor Vergata

    Roma, Italy

    Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, Italy

    Recruiting

  • A O Universitaria Senese Ospedale Santa Maria alle Scotte

    Siena, Italy

    Recruiting

  • AO Ordine Mauriziano

    Torino, Italy

    Recruiting

  • ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi

    Varese, Italy

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, Italy

    Recruiting

Showing 21 of 21 sites. 20 of the 21 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07220824. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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