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

Recruitingn/aAges 18 Years - anyAllCelltrion HealthCare France
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Be an adult (18 years of age or older at the time of inclusion) followed in specialty care and diagnosed with of one of the following conditions: Crohn's disease, Plaque psoriasis * Treated for at least 6 months prior to inclusion with the reference Ustekinumab for the pathology in question: Crohn's disease, Plaque psoriasis * Stable for at least 3 months according to the prescribing physician and in clinical remission according to the specific disease activity score. * For whom the specialist has decided to switch to the biosimilar treatment developed and marketed by Celltrion on the day of inclusion (shared medical decision independent of the study) * Have an email address. * Have a mobile phone number. * Be able to understand and complete questionnaires in French. * Not opposed to participating in the study. * Be affiliated to a French Social Security scheme or be a beneficiary of such a scheme. Exclusion Criteria: * Patients under guardianship or otherwise deprived of their freedom. * Pregnant women or women of childbearing potential who wish to become pregnant while taking one of the study treatments. * Patients participating at the time of inclusion in a clinical trial or other clinical study that prohibits simultaneous participation in other studies. * Contraindication to study products.
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What it tests

  • Ustekinumab 45 mg
  • Ustekinumab 90 mg
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Where

1 site
CHU Amiens
Amiens, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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