A Study of Guselkumab in Participants With Psoriatic Arthritis (PsA) in a Real-World Setting
GURU
GUselkumab for the Treatment of PsA: Effectiveness Results by Ultrasound
1 other identifier
observational
200
1 country
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2025
CompletedFirst Posted
Study publicly available on registry
October 24, 2025
CompletedStudy Start
First participant enrolled
December 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
April 13, 2026
April 1, 2026
1.7 years
October 22, 2025
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage Reduction From Baseline in Global OMERACT and EULAR Synovitis Score (GLOESS) at Week 12
GLOESS is an ultrasound scoring system to assess the presence and severity of synovitis measured for 24 pairs of joints. The scoring is from 0 to 3 for each joint where 0: No abnormalities or changes, 1: Mild changes, 2: Moderate changes and 3: Severe changes. The total score for 48 joints can range from 0 to 144, where higher score indicates more inflammation.
Baseline and Week 12
Percentage of Participants Achieving Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity (LDA) Score Less Than or Equal to 14, at Week 24
Percentage of participants achieving DAPSA LDA (that is, a score less than or equal to \[\<=\] 14) will be reported. DAPSA assesses the joint domain of PsA and is derived from the sum of the following components: Participant's assessment of pain on visual analog scale (VAS ; 0-10 centimeters \[cm\]; VAS 0= excellent; 10= poor), Participant's global assessment of disease activity on VAS (0 to 10 cm VAS, 0=excellent and 10=poor), tender joint count (0-68), swollen joint count (0-66) and C-reactive protein (CRP) level. A higher score indicates more active disease activity.
Week 24
Secondary Outcomes (9)
Percentage of Participants Achieving Resolution of Enthesitis by Ultrasound at Week 12
Week 12
Percentage Reduction from Baseline in Spondyloarthritis Research Consortium of Canada (SPAARC) Index at Week 24
Baseline and Week 24
Percentage of Participants Achieving DAPSA Remission at Week 24
Week 24
Percentage of Participants Achieving DAPSA LDA/Remission at Week 52
Week 52
Number of Participants Achieving Minimal Disease Activity (MDA) at Weeks 12, 24 and 52
At Weeks 12, 24 and 52
- +4 more secondary outcomes
Study Arms (1)
Group 1: Psoriatic Arthritis
Participants with confirmed diagnosis of psoriatic arthritis treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice, including results of ultrasound examinations, will be collected in this study. Additionally, questions will be asked from participants about their health and well-being.
Eligibility Criteria
The study population will include participants affected with PsA according to classification for psoriatic arthritis (CASPAR) criteria.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Policlinico di Bari
Bari, 70124, Italy
ASST Spedali Civili Brescia
Brescia, 25123, Italy
Hospital Carlo Urbani
Iesi, 60035, Italy
IRCCS Ospedale Galeazzi Sant Ambrogio
Milan, 20157, Italy
Istituto Ortopedico Gaetano Pini
Milan, 20122, Italy
San Raffaele Hospital
Milan, 20132, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, 80131, Italy
Seconda Univesità degli Studi di Napoli, AOU
Naples, 80131, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Universita degli Studi di Perugia
Perugia, 06123, Italy
Ospedale Santa Chiara AO Universitaria Pisana
Pisa, 56126, Italy
Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale
Potenza, 85100, Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, 42123, Italy
Policlinico Di Tor Vergata
Roma, 00133, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00136, Italy
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Siena, 53100, Italy
AO Ordine Mauriziano
Torino, 10128, Italy
ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
Varese, 21100, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37134, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2025
First Posted
October 24, 2025
Study Start
December 4, 2025
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.