Guselkumab for people with psoriatic arthritis in routine care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Policlinico di Bari
  Bari, Italy Recruiting
• ASST Spedali Civili Brescia
  Brescia, Italy Recruiting
• Hospital Carlo Urbani
  Iesi, Italy Recruiting
• IRCCS Ospedale Galeazzi Sant Ambrogio
  Milan, Italy Recruiting
• Istituto Ortopedico Gaetano Pini
  Milan, Italy Recruiting
• San Raffaele Hospital
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Guselkumab after Ustekinumab in adults with moderate-to-severe psoriasis in routine care

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.