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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Arthritis
    Psoriatic

NCT07220824

Janssen Research & Development, LLC

1 February 2026

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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