Follows patients with Crohn disease or plaque psoriasis switching to Steqeyma
Observes patients with Crohn disease or plaque psoriasis who switch to Steqeyma, an ustekinumab biosimilar.
Plain-language title generated from the registry record
Registry title: ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
Key facts
- Where
- Amiens, FranceSee the site
Where in France
- CHU AmiensAmiens, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Celltrion HealthCare France
- Trial code
- NCT06997055
- Record updated
- 30 May 2025
- Original description
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.Read full original descriptionShow less
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
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.
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.