ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCelltrion HealthCare France
About this trial
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
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ustekinumab 45 mg
- Ustekinumab 90 mg
Treatment groups
225 Participants
are divided into 2 treatment groupsSponsors and collaborators
Celltrion HealthCare France
Lead sponsor
Sanoia
Collaborator
Source ClinicalTrials.gov