Actively Recruiting
ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
Led by Celltrion HealthCare France · Updated on 2025-05-30
225
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
Sponsors
C
Celltrion HealthCare France
Lead Sponsor
S
Sanoia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with Crohn's disease or plaque psoriasis
- Treated with reference ustekinumab for at least 6 months prior to inclusion
- Stable and in clinical remission for at least 3 months according to the prescribing physician and disease activity score
- Physician independently decided to switch to the STEQEYMA4 biosimilar at inclusion
- Have an email address
- Have a mobile phone number
- Able to understand and complete questionnaires in French
- Not opposed to participating in the study
- Affiliated with or beneficiary of a French Social Security scheme
You will not qualify if you...
- Patients under guardianship or deprived of their freedom
- Pregnant women or women of childbearing potential wishing to become pregnant during treatment
- Participants currently enrolled in another clinical trial or study that prohibits simultaneous participation
- Contraindications to the study products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU Amiens
Amiens, France
Actively Recruiting
Research Team
S
Salim BENKHALIFA, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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