Actively Recruiting
Guselkumab for the Treatment of Psoriatic Arthritis: Effectiveness Results by Ultrasound
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
200
Participants Needed
21
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well guselkumab works to improve symptoms of psoriatic arthritis, an inflammatory joint disease affecting people with psoriasis, which causes red, scaly skin patches. This observational study uses musculoskeletal ultrasound (MSUS) to assess treatment effects in a real-world setting, focusing on participants with active psoriatic arthritis who are treated with guselkumab as part of standard care. Participants with confirmed psoriatic arthritis treated with guselkumab according to usual clinical practice will be included. No study drugs are provided; instead, data collected during routine care, including ultrasound exam results, will be gathered. Participants will also be asked questions about their health and well-being as part of the study. During the study, researchers will measure changes in joint inflammation using ultrasound and assess disease activity and pain at several time points, including weeks 12, 24, and 52. They will track improvement in enthesitis, persistence with guselkumab treatment, physical function, and any adverse events. The study duration allows monitoring up to 52 weeks, with assessments based on clinical and imaging data obtained during routine visits.
CONDITIONS
Brief Title
A Study of Guselkumab in Participants With Psoriatic Arthritis (PsA) in a Real-World Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of psoriatic arthritis as per CASPAR criteria for at least six months with active disease
- Tender joint count (TJC) \u2265 3/68 and swollen joint count (SJC) \u2265 3/66 at baseline, or CRP \u2265 0.3 mg/dL if TJC and/or SJC \u003c 3
- Total synovitis PDUS score \u2265 2 and inflammation related to PD signal \u2265 2 for at least 1 affected joint, or PDUS score \u2265 2 and inflammation related to PD signal \u2265 1 for at least 2 affected joints at baseline
- Starting guselkumab for psoriatic arthritis as part of standard care at enrollment or within two weeks after baseline
- Biologic-na�efve or previously exposed to only one biologic DMARD and/or apremilast/deucravacitinib
- At least one clinically involved enthesitis site (SPARCC index \u2265 1) and one imaging-detected enthesitis site at baseline
You will not qualify if you...
- Previous exposure to guselkumab or more than one biologic DMARD for any indications
- Prior treatment with Janus kinase (JAK) inhibitors
- Contraindications to guselkumab as per product characteristics
- Current enrollment in another investigational study or completed such a study less than 30 days ago
- Current enrollment in an observational study with guselkumab sponsored or managed by the same sponsor
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants who undergo routine care with guselkumab for psoriatic arthritis are observed. Data including ultrasound results and health assessments are collected during standard clinical visits.
Visits aligned with routine clinical care up to Week 52
Trial Site Locations
Total: 21 locations
1
Policlinico di Bari
Bari, Italy, 70124
Actively Recruiting
2
ASST Spedali Civili Brescia
Brescia, Italy, 25123
Actively Recruiting
3
Hospital Carlo Urbani
Iesi, Italy, 60035
Actively Recruiting
4
IRCCS Ospedale Galeazzi Sant Ambrogio
Milan, Italy, 20157
Actively Recruiting
5
Istituto Ortopedico Gaetano Pini
Milan, Italy, 20122
Actively Recruiting
6
San Raffaele Hospital
Milan, Italy, 20132
Actively Recruiting
7
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
8
Azienda Ospedaliera Universitaria Federico II
Naples, Italy, 80131
Actively Recruiting
9
Seconda Univesità degli Studi di Napoli, AOU
Naples, Italy, 80131
Actively Recruiting
10
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Completed
11
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
12
Universita degli Studi di Perugia
Perugia, Italy, 06123
Actively Recruiting
13
Ospedale Santa Chiara AO Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
14
Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
Potenza, Italy, 85100
Actively Recruiting
15
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, Italy, 42123
Actively Recruiting
16
Policlinico Di Tor Vergata
Roma, Italy, 00133
Actively Recruiting
17
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy, 00136
Actively Recruiting
18
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Siena, Italy, 53100
Actively Recruiting
19
AO Ordine Mauriziano
Torino, Italy, 10128
Actively Recruiting
20
ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
Varese, Italy, 21100
Actively Recruiting
21
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37134
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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