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Ultrasound study to see if guselkumab eases psoriatic arthritis

NCT ID NCT07220824

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study is testing how well the drug guselkumab works for people with psoriatic arthritis, a condition that causes joint pain and skin patches. Researchers will use ultrasound to measure joint inflammation in 200 participants over 24 weeks. The goal is to see if guselkumab reduces symptoms in a real-world setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
guselkumab
What this could lead to
If successful, this could show that guselkumab effectively reduces joint inflammation in psoriatic arthritis, supporting its use in routine care.
What could go wrong
This is an observational study without a placebo group, so results may be less conclusive. It is also relatively small and early-stage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include participants affected with PsA according to classification for psoriatic arthritis (CASPAR) criteria.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A O Universitaria Senese Ospedale Santa Maria alle Scotte

    RECRUITING

    Siena, 53100, Italy

  • AO Ordine Mauriziano

    RECRUITING

    Torino, 10128, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • ASST Spedali Civili Brescia

    RECRUITING

    Brescia, 25123, Italy

  • ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi

    RECRUITING

    Varese, 21100, Italy

  • Arcispedale Santa Maria Nuova - IRCCS

    RECRUITING

    Reggio Emilia, 42123, Italy

  • Azienda Ospedaliera Universitaria Federico II

    RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona

    RECRUITING

    Verona, 37134, Italy

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    COMPLETED

    Palermo, 90127, Italy

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, 27100, Italy

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    RECRUITING

    Roma, 00136, Italy

  • Hospital Carlo Urbani

    RECRUITING

    Iesi, 60035, Italy

  • IRCCS Ospedale Galeazzi Sant Ambrogio

    RECRUITING

    Milan, 20157, Italy

  • Istituto Ortopedico Gaetano Pini

    RECRUITING

    Milan, 20122, Italy

  • Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale

    RECRUITING

    Potenza, 85100, Italy

  • Ospedale Santa Chiara AO Universitaria Pisana

    RECRUITING

    Pisa, 56126, Italy

  • Policlinico Di Tor Vergata

    RECRUITING

    Roma, 00133, Italy

  • Policlinico di Bari

    RECRUITING

    Bari, 70124, Italy

  • San Raffaele Hospital

    RECRUITING

    Milan, 20132, Italy

  • Seconda Univesità degli Studi di Napoli, AOU

    RECRUITING

    Naples, 80131, Italy

  • Universita degli Studi di Perugia

    RECRUITING

    Perugia, 06123, Italy

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