One-year guselkumab use in adults with psoriatic arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Guselkumab after Ustekinumab in adults with moderate-to-severe psoriasis in routine care

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.