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.
Key facts
- Who runs it
- Celltrion HealthCare France
- Where
- Amiens, FranceSee the site
- Trial code
- Registry title
- ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
- Status
- Recruiting
- People taking part
- 225 people, planned
- Started
- 17 Mar 2025
- Expected to end
- 31 Dec 2027
- Type of study
- Observational, 2 groups
- Treatments tested
- Ustekinumab 45 mg
- Ustekinumab 90 mg
- Record updated
- 30 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Crohn's disease or plaque psoriasis. They have been in remission on the reference ustekinumab and their doctor has decided to switch them to the biosimilar Steqeyma.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Crohn's disease or plaque psoriasis, in clinical remission and stable for at least 3 months
- Earlier treatment
- Treated for at least 6 months with the reference ustekinumab. The specialist has decided to switch to the Celltrion biosimilar on the day of inclusion.
Main reasons for not taking part
- Patients under guardianship or deprived of their freedom
- Pregnant women, or women who may become pregnant and wish to while on study treatment
- Taking part in another clinical study that does not allow other studies
- Contraindication to the study products
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in France
- CHU AmiensAmiens, FranceContact: Salim BENKHALIFA, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- CD group
Switch from ustekinumab originator in patients with Crohn's disease
Treatment: Ustekinumab 45 mg and Ustekinumab 90 mg
- Psoriasis Group
Switch from ustekinumab originator in patients with Plaque Psoriasis
Treatment: Ustekinumab 45 mg and Ustekinumab 90 mg
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Follows patients with Crohn disease or plaque psoriasis switching to SteqeymaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 30 May 2025