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

Inclusion Criteria9

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 Criteria4

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.