Ultrasound study to see if guselkumab eases psoriatic arthritis
NCT ID NCT07220824
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
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
20 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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A O Universitaria Senese Ospedale Santa Maria alle Scotte
RECRUITINGSiena, 53100, Italy
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AO Ordine Mauriziano
RECRUITINGTorino, 10128, Italy
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ASST Grande Ospedale Metropolitano Niguarda
RECRUITINGMilan, 20162, Italy
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ASST Spedali Civili Brescia
RECRUITINGBrescia, 25123, Italy
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ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
RECRUITINGVarese, 21100, Italy
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Arcispedale Santa Maria Nuova - IRCCS
RECRUITINGReggio Emilia, 42123, Italy
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Azienda Ospedaliera Universitaria Federico II
RECRUITINGNaples, 80131, Italy
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Azienda Ospedaliera Universitaria Integrata Verona
RECRUITINGVerona, 37134, Italy
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Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
COMPLETEDPalermo, 90127, Italy
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Fondazione IRCCS Policlinico San Matteo
RECRUITINGPavia, 27100, Italy
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Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITINGRoma, 00136, Italy
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Hospital Carlo Urbani
RECRUITINGIesi, 60035, Italy
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IRCCS Ospedale Galeazzi Sant Ambrogio
RECRUITINGMilan, 20157, Italy
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Istituto Ortopedico Gaetano Pini
RECRUITINGMilan, 20122, Italy
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Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
RECRUITINGPotenza, 85100, Italy
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Ospedale Santa Chiara AO Universitaria Pisana
RECRUITINGPisa, 56126, Italy
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Policlinico Di Tor Vergata
RECRUITINGRoma, 00133, Italy
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Policlinico di Bari
RECRUITINGBari, 70124, Italy
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San Raffaele Hospital
RECRUITINGMilan, 20132, Italy
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Seconda Univesità degli Studi di Napoli, AOU
RECRUITINGNaples, 80131, Italy
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Universita degli Studi di Perugia
RECRUITINGPerugia, 06123, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an approved arthritis drug stop early joint damage?
- Nanobody injection put to the test against psoriatic arthritis
- New study to measure drug levels in breast milk of moms on TREMFYA
- New drug shows promise in taming psoriatic arthritis flares
- New injection targets psoriatic arthritis pain in small trial
- New study tracks arthritis drug persistence in daily life