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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