NCT06997055Recruiting
ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
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
Source: ClinicalTrials.gov · Last updated 30 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 225 (estimated)
- First submitted
- 21 May 2025
- Start date
- 17 Mar 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Celltrion HealthCare France
- Diseases
- Psoriasis, Crohn's disease
- NCT number
- NCT06997055
What you commit to
- Study type: Observational
- Planned participants: 225
- From 17 Mar 2025 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.