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Guselkumab for people with psoriatic arthritis in routine care

GUselkumab for the Treatment of PsA: Effectiveness Results by Ultrasound

Janssen Research & Development, LLC · NCT07220824

This study will test whether guselkumab given in routine clinical care reduces joint inflammation in people with psoriatic arthritis using musculoskeletal ultrasound to track changes.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC (industry)
Drugs / interventionsGuselkumab, deucravacitinib
Locations21 sites (Bari and 20 other locations)
Trial IDNCT07220824 on ClinicalTrials.gov

What this trial studies

This is a prospective observational study following people with psoriatic arthritis who start guselkumab as part of routine care, using musculoskeletal ultrasound (MSUS) to measure synovitis and power Doppler signal over time. Participants must meet CASPAR criteria for PsA for at least six months and have active joint disease by joint counts or CRP plus predefined ultrasound synovitis thresholds at baseline. Clinical measures (tender and swollen joint counts, CRP) will be collected alongside MSUS scoring of up to 48 joints to document real-world treatment effects. The study is conducted at participating clinical centers in Italy and does not assign treatment beyond usual clinical practice.

Who should consider this trial

Good fit: Adults with psoriatic arthritis (per CASPAR) of at least six months' duration who have active disease (TJC ≥3 and SJC ≥3 or elevated CRP) and meet the study's ultrasound synovitis thresholds who are starting guselkumab in routine care.

Not a fit: People who do not have ultrasound-confirmed active joint inflammation or who are not initiating guselkumab as part of their usual care would not be expected to benefit from participation in this observational protocol.

Why it matters

Potential benefit: If successful, this could show that guselkumab reduces ultrasound-detected joint inflammation in typical clinical settings and help inform everyday treatment decisions.

How similar studies have performed: Randomized controlled trials have shown guselkumab improves signs and symptoms of PsA, but there are relatively few real-world studies that use musculoskeletal ultrasound to document changes in synovitis specifically.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Bari and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Arthritis, Psoriatic

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.