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Recruiting NCT07532226

A Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Participants

— 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
France
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

A Real-World, Prospective Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Patients

Overview

This observational study aims to assess the 1-year persistence of guselkumab in adult patients with psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes red, scaly patches).

Primary outcome measures

  • Proportion of Participants Still Receiving Treatment at 1 Year [Time frame: At 1 year]
  • Percentage of Participants Still Receiving Treatment at Persistence Time [Time frame: Up to 8 weeks]
  • Number of Participants Starting New Treatment [Time frame: At 1 year]
Secondary outcome measures (12)
  • Percentage of Participants Still Receiving Treatment at 2 years [Time frame: At 2 years]
  • Percentage of Participants Discontinuing The Treatment [Time frame: At 2 years]
  • Change From Baseline in Disease Activity Index in Psoriatic Arthritis (DAPSA)/ Clinical Disease Activity Index in Psoriatic Arthritis (cDAPSA) [Time frame: Baseline, Months 3,6,12,18, and 24]
  • Change From Baseline in Leeds Enthesitis Index (LEI) Score [Time frame: Baseline, Months 3,6,12,18, and 24]
  • Change From Baseline in Back and Neck Pain Numerical Rating Scale (NRS) Score [Time frame: Baseline, Months 3,6,12,18, and 24]
  • Hazard Ratios Between Baseline Clinical Factors and Guselkumab Persistence and Effectiveness at Months 12 and 24 [Time frame: At Month 12 and 24]
  • Sociodemographic Characteristics: Age [Time frame: At Baseline]
  • Sociodemographic Characteristics: Sex [Time frame: At Baseline]
  • Sociodemographic Characteristics: Weight [Time frame: At Baseline]
  • Sociodemographic Characteristics: Height [Time frame: At Baseline]
  • Sociodemographic Characteristics: Body Mass Index (BMI) [Time frame: At Baseline]
  • Number of Participants Reporting Smoking, Cannabis and Alcohol Use [Time frame: At Baseline]

Eligibility criteria

Inclusion criteria

  • Have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist with reference to ClASsification criteria for Psoriatic ARthritis (CASPAR)
  • Start guselkumab as a first, second, third, or fourth line of disease-modifying antirheumatic drug (bDMARD) therapy for the indication of PsA as part of standard clinical practice at the time of enrollment into the observational study
  • Initiating guselkumab treatment according to Summary of Product Characteristics (SmPC) indication
  • The treatment decision must be taken by the participating rheumatologist prior to, and independently of the patient's inclusion into the study, following clinical practice in accordance with local and overarching guidelines and local regulations
  • Must have received the information note, given his/her oral agreement and has not objected to the collection of his/her data in accordance with French requirements

Exclusion criteria

  • Have already taken a specific interleukin-23 inhibitor (IL-23i) treatment.
  • Are receiving combination therapy: 2 or more targeted therapies (biotherapy, Janus kinase \[JAK\] inhibitor, phosphodiesterase 4 (PDE4) inhibitor) indicated for PsA/PsO at the same time
  • Has a contra-indication to guselkumab according to the SmPC (for hypersensitivity or due to active clinically important infection, example active tuberculosis)
  • Unwilling or unable to participate in long-term data collection
  • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study ( that is, signing of informed consent)
  • Currently enrolled in any interventional study or any Janssen-Cilag France-sponsored observational clinical study
  • Is under guardianship or curatorship, judicial protection, future protection mandate or under family authorization

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

France · 1 center
  • Hopital Roger Salengro - CHU Lille — Lille

Identifiers

NCT: NCT07532226 · CNTO1959PSA4021 · CNTO1959PSA4021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗