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ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
Sponsor: Celltrion HealthCare France
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
225
Start Date
2025-03-17
Completion Date
2027-12-31
Last Updated
2025-05-30
Healthy Volunteers
No
Conditions
Interventions
Ustekinumab 45 mg
biosimilar
Ustekinumab 90 mg
biosimilar
Locations (1)
CHU Amiens
Amiens, France