Psoriasis Clinical Trials

Find Psoriasis Clinical Trials Near You

GUselkumab for the Treatment of PsA: Effectiveness Results by Ultrasound

Status: Recruiting
Location: See all (21) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Policlinico di Bari
RECRUITING
Bari
ASST Spedali Civili Brescia
RECRUITING
Brescia
Hospital Carlo Urbani
RECRUITING
Iesi
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
IRCCS Ospedale Galeazzi Sant Ambrogio
RECRUITING
Milan
Istituto Ortopedico Gaetano Pini
RECRUITING
Milan
San Raffaele Hospital
RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Naples
Seconda Univesità degli Studi di Napoli, AOU
RECRUITING
Naples
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
RECRUITING
Palermo
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Universita degli Studi di Perugia
RECRUITING
Perugia
Ospedale Santa Chiara AO Universitaria Pisana
RECRUITING
Pisa
Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
RECRUITING
Potenza
Arcispedale Santa Maria Nuova - IRCCS
RECRUITING
Reggio Emilia
Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITING
Roma
Policlinico Di Tor Vergata
RECRUITING
Roma
A O Universitaria Senese Ospedale Santa Maria alle Scotte
RECRUITING
Siena
AO Ordine Mauriziano
RECRUITING
Torino
ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
RECRUITING
Varese
Azienda Ospedaliera Universitaria Integrata Verona
RECRUITING
Verona
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-12-04
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 200
Treatments
Group 1: Psoriatic Arthritis
Participants with confirmed diagnosis of psoriatic arthritis treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice, including results of ultrasound examinations, will be collected in this study. Additionally, questions will be asked from participants about their health and well-being.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov