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RECRUITING
NCT06997055

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

Sponsor: Celltrion HealthCare France

View on ClinicalTrials.gov

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

Interventions

DRUG

Ustekinumab 45 mg

biosimilar

DRUG

Ustekinumab 90 mg

biosimilar

Locations (1)

CHU Amiens

Amiens, France