NCT07220824Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 22 Oct 2025
- Start date
- 4 Dec 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT07220824
What you commit to
- Study type: Observational
- Planned participants: 200
- From 4 Dec 2025 to the primary completion date, 31 Jul 2027
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous exposure to Guselkumab or to more than one bDMARD for any indications
- Prior treatment with Janus kinase (JAK) inhibitors
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico di Bari Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| ASST Spedali Civili Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Hospital Carlo Urbani Coordinator of this site? Confirm its status | Iesi | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| San Raffaele Hospital Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituto Ortopedico Gaetano Pini Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Ospedale Galeazzi Sant'Ambrogio Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Seconda Univesità degli Studi di Napoli, AOU Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Completed |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Università degli Studi di Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| Ospedale Santa Chiara AO Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale Coordinator of this site? Confirm its status | Potenza | Italy | Recruiting |
| Arcispedale Santa Maria Nuova - IRCCS Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| Policlinico Di Tor Vergata Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| A O Universitaria Senese Ospedale Santa Maria alle Scotte Coordinator of this site? Confirm its status | Siena | Italy | Recruiting |
| AO Ordine Mauriziano Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
| ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi Coordinator of this site? Confirm its status | Varese | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.