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

NCT07220824 · tracked via the Priya Life Science Italy tracker

Sponsor

Janssen Research & Development, LLC

Phase

Observational

Started

2025-12-04

Last updated

2026-09-25

Condition(s) studied

Arthritis, Psoriatic

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Percentage Reduction From Baseline in Global OMERACT and EULAR Synovitis Score (GLOESS) at Week 12 — Baseline and Week 12
GLOESS is an ultrasound scoring system to assess the presence and severity of synovitis measured for 24 pairs of joints. The scoring is from 0 to 3 for each joint where 0: No abnormalities or changes, 1: Mild changes, 2: Moderate changes and 3: Severe changes. The total score for 48 joints can range from 0 to 144, where higher score indicates more inflammation.
Percentage of Participants Achieving Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity (LDA) Score Less Than or Equal to 14, at Week 24 — Week 24
Percentage of participants achieving DAPSA LDA (that is, a score less than or equal to \[\<=\] 14) will be reported. DAPSA assesses the joint domain of PsA and is derived from the sum of the following components: Participant's assessment of pain on visual analog scale (VAS ; 0-10 centimeters \[cm\]; VAS 0= excellent; 10= poor), Participant's global assessment of disease activity on VAS (0 to 10 cm VAS, 0=excellent and 10=poor), tender joint count (0-68), swollen joint count (0-66) and C-reactive protein (CRP) level. A higher score indicates more active disease activity.

Trial sites (21)

Facility	City	Region	Status
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

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Other trials for the same condition

A Study of Guselkumab in Participants With Active Psoriatic Arthritis Active, not recruiting

A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice Active, not recruiting

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants Recruiting

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease Active, not recruiting

A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07220824 on ClinicalTrials.gov ↗ ← All trials in Italy