One-year guselkumab use in adults with psoriatic arthritis
A Real-World, Prospective Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Patients
This project will see how long adults with psoriatic arthritis stay on guselkumab over one year when prescribed as part of routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen-Cilag Ltd. Industry-sponsored |
| Drugs / interventions | guselkumab |
| Locations | 1 site (Lille) |
| Trial ID | NCT07532226 on ClinicalTrials.gov |
What this trial studies
This is an observational follow-up of adults with confirmed psoriatic arthritis who begin guselkumab as part of routine clinical care. Participants are enrolled after the treating rheumatologist independently decides to start guselkumab, and inclusion requires PsA diagnosis referenced to the CASPAR criteria and consent under French regulations. The main outcome is treatment persistence over one year, captured from clinical records at scheduled visits. Data are collected at a single participating center (CHU Lille) and no experimental interventions are administered beyond usual care.
Who should consider this trial
Good fit: Adults with a confirmed diagnosis of psoriatic arthritis by a rheumatologist (per CASPAR) who are about to start guselkumab as a first through fourth line bDMARD and who consent to data collection under French requirements.
Not a fit: Patients who are not starting guselkumab, who cannot attend the participating center in Lille, or who do not consent to data collection are not likely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help clinicians and patients understand real-world treatment retention with guselkumab and inform treatment planning.
How similar studies have performed: Other real-world persistence studies of biologic therapies in psoriatic arthritis have provided useful retention data, but long-term real-world evidence specifically for guselkumab remains relatively limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille
- Hopital Roger Salengro - CHU Lille — Lille, France (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.