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Recruiting NCT07220824

A Study of Guselkumab in Participants With Psoriatic Arthritis (PsA) in a Real-World Setting

— Observational Arthritis, Psoriatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Arthritis, Psoriatic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

GUselkumab for the Treatment of PsA: Effectiveness Results by Ultrasound

Overview

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.

Primary outcome measures

  • Percentage Reduction From Baseline in Global OMERACT and EULAR Synovitis Score (GLOESS) at Week 12 [Time frame: 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 [Time frame: Week 24]
Secondary outcome measures (9)
  • Percentage of Participants Achieving Resolution of Enthesitis by Ultrasound at Week 12 [Time frame: Week 12]
  • Percentage Reduction from Baseline in Spondyloarthritis Research Consortium of Canada (SPAARC) Index at Week 24 [Time frame: Baseline and Week 24]
  • Percentage of Participants Achieving DAPSA Remission at Week 24 [Time frame: Week 24]
  • Percentage of Participants Achieving DAPSA LDA/Remission at Week 52 [Time frame: Week 52]
  • Number of Participants Achieving Minimal Disease Activity (MDA) at Weeks 12, 24 and 52 [Time frame: At Weeks 12, 24 and 52]
  • Percentage of Participants Achieving Reduction in VAS Pain Scores at Week 12 and 24 [Time frame: At Weeks 12, and 24]
  • Number of Participants with Improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) At Weeks 12 and 24 [Time frame: At Weeks 12 and 24]
  • Number of Participants with Persistence to Guselkumab Treatment up to 52 Weeks [Time frame: Up to Week 52]
  • Number of Participants with Adverse Events (AEs) [Time frame: Up to Week 52]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 21 centers
  • Policlinico di Bari — Bari
  • ASST Spedali Civili Brescia — Brescia
  • Hospital Carlo Urbani — Iesi
  • IRCCS Ospedale Galeazzi Sant Ambrogio — Milan
  • Istituto Ortopedico Gaetano Pini — Milan
  • San Raffaele Hospital — Milan
  • ASST Grande Ospedale Metropolitano Niguarda — Milan
  • Azienda Ospedaliera Universitaria Federico II — Naples
  • … and 13 more centers

Identifiers

NCT: NCT07220824 · CNTO1959PSA4020 · CNTO1959PSA4020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗