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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Maintenance of remission, 12 months after initiation of biosimilar treatment — 12 months Percentage of patients still in clinical remission 12 months after initiation of biosimilar treatment according to the definitions used in the inclusion criteria.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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