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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Locations (20)

Policlinico di Bari
Bari, Italy
ASST Spedali Civili Brescia
Brescia, Italy
Hospital Carlo Urbani
Iesi, Italy
IRCCS Ospedale Galeazzi Sant Ambrogio
Milan, Italy
Istituto Ortopedico Gaetano Pini
Milan, Italy
San Raffaele Hospital
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Seconda Univesità degli Studi di Napoli, AOU
Naples, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Universita degli Studi di Perugia
Perugia, Italy
Ospedale Santa Chiara AO Universitaria Pisana
Pisa, Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, Italy
Policlinico Di Tor Vergata
Roma, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Siena, Italy
AO Ordine Mauriziano
Torino, Italy
ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
Varese, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy