Status:
RECRUITING
ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
Lead Sponsor:
Celltrion HealthCare France
Collaborating Sponsors:
Sanoia
Conditions:
Crohn Disease
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Brief 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 phys...
Detailed Description
Biotherapies have revolutionized the management of chronic inflammatory diseases in gastroenterology (Crohn's disease and ulcerative colitis), dermatology (e.g. plaque psoriasis and chronic spontaneou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT06997055
Start Date
March 17 2025
End Date
December 31 2027
Last Update
May 30 2025
Active Locations (1)
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1
CHU Amiens
Amiens, France