Crohn'sRecruiting
ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
Observational · No treatment assigned · 1 site · Celltrion HealthCare France
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease and Plaque Psoriasis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 6 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 225 participants are expected to take part.
- Start date: 2025-03-17.
- Main results expected around 2027-09-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Maintenance of remission, 12 months after initiation of biosimilar treatment (12 months)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease; Plaque Psoriasis |
| Lead sponsor | Celltrion HealthCare France |
| Collaborators | Sanoia |
| Enrollment | 225 (estimated) |
| Start date | 2025-03-17 |
| Primary completion (est.) | 2027-09-30 |
| First posted | 2025-05-30 |
| Last updated | 2025-05-30 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06997055 |
Interventions
- Ustekinumab 45 mg (Drug)
biosimilar - Ustekinumab 90 mg (Drug)
biosimilar
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens | Amiens | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.