A Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Participants
Recruiting
Observational Study
Arthritis, Psoriatic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Janssen-Cilag Ltd. · Industry
Who this trial is looking for
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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).
Trial Locations
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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) th…
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
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