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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
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

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Policlinico di Bari
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BariItalyRecruiting
ASST Spedali Civili Brescia
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BresciaItalyRecruiting
Hospital Carlo Urbani
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IesiItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
San Raffaele Hospital
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MilanItalyRecruiting
Istituto Ortopedico Gaetano Pini
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MilanItalyRecruiting
IRCCS Ospedale Galeazzi Sant'Ambrogio
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MilanItalyRecruiting
Seconda Univesità degli Studi di Napoli, AOU
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NaplesItalyRecruiting
Azienda Ospedaliera Universitaria Federico II
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NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
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PalermoItalyCompleted
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyRecruiting
Università degli Studi di Perugia
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PerugiaItalyRecruiting
Ospedale Santa Chiara AO Universitaria Pisana
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PisaItalyRecruiting
Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
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PotenzaItalyRecruiting
Arcispedale Santa Maria Nuova - IRCCS
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Reggio EmiliaItalyRecruiting
Policlinico Di Tor Vergata
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RomaItalyRecruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
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RomaItalyRecruiting
A O Universitaria Senese Ospedale Santa Maria alle Scotte
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SienaItalyRecruiting
AO Ordine Mauriziano
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TorinoItalyRecruiting
ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
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VareseItalyRecruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.