RecruitingNCT06997055

ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar

ROLL'YN-UST: Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Steqeyma®, un Biosimilaire de l'ustékinumab

Sponsor

Celltrion HealthCare France

Enrollment

225 participants

Start Date

Mar 17, 2025

Study Type

OBSERVATIONAL

Conditions

Crohn Disease Plaque Psoriasis

Summary

ROLL'YN-UST is a real-life study, which includes patients in clinical remission for at least 3 months and who have been treated with a reference biotherapy for at least 6 months, and for whom the physician has decided, independently of the study and as part of a shared medical decision, to switch them to STEQEYMA®. The main aim of this study is to the maintenance of clinical remission 12 months after initiation of a biosimilar as well as patient satisfaction 6 and 12 months after initiation of a biosimilar.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study in France monitors patients with Crohn's disease or plaque psoriasis who are switching from the original version of the biologic drug ustekinumab to a biosimilar version (Steqeyma). Researchers want to see how patients fare after the switch, including quality of life and disease control. **You may be eligible if...** - You are 18 or older with Crohn's disease or plaque psoriasis - You have been on the reference ustekinumab for at least 6 months - Your disease has been stable and in clinical remission for at least 3 months - Your specialist has decided to switch you to the biosimilar (Steqeyma) - You have a mobile phone and email address - You speak French and can complete questionnaires **You may NOT be eligible if...** - You are under guardianship or legally restricted - You are pregnant or planning pregnancy while on the study medication - You are enrolled in another clinical trial that prohibits participation in other studies - You have a contraindication to the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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