NCT06997055 ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
| NCT ID | NCT06997055 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Celltrion HealthCare France |
| Condition | Crohn Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 225 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 225 participants in total. It began in 2025-03-17 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06997055 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06997055 currently recruiting?
Yes, NCT06997055 is actively recruiting participants. Contact the research team at etudescliniques_fr@celltrionhc.com for enrollment information.
Where is the NCT06997055 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT06997055 clinical trial?
NCT06997055 is sponsored by Celltrion HealthCare France. The trial plans to enroll 225 participants.