Actively Recruiting
A Study of Guselkumab in Participants With Psoriatic Arthritis (PsA) in a Real-World Setting
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
200
Participants Needed
21
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 for at least six months according to CASPAR criteria
- Active psoriatic arthritis defined by tender joint count (TJC) ≥ 3/68 and swollen joint count (SJC) ≥ 3/66 or C-reactive protein (CRP) ≥ 0.3 mg/dL if TJC and/or SJC < 3
- Total synovitis power doppler ultrasound (PDUS) score ≥ 2 with inflammation PD signal ≥ 2 in at least 1 of 48 joints, or PDUS score ≥ 2 with PD signal ≥ 1 in at least 2 of 48 joints at baseline
- Starting guselkumab treatment as part of standard care at enrollment or within 2 weeks after baseline
- Biologic-naïve or previously exposed to only one biologic DMARD and/or apremilast/deucravacitinib
- At least one clinically involved enthesitis site (SPARCC index ≥ 1) and one imaging-detected enthesitis site at baseline
You will not qualify if you...
- Previous use of guselkumab or more than one biologic DMARD for any indication
- Prior treatment with Janus kinase (JAK) inhibitors
- Contraindications to guselkumab per product summary
- Current participation in another investigational study or completed one less than 30 days ago
- Current participation in an observational study with guselkumab sponsored or managed by the same sponsor
AI-Screening
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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
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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