ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
Recruiting · NCT06997055 · Observational (researchers observe without assigning treatment) · Lead sponsor: Celltrion HealthCare France
View the official record on ClinicalTrials.gov →Interventions studied
Ustekinumab 45 mgUstekinumab 90 mg
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
2 locations listed.
- CHU Amiens - Amiens, France
- CHU Amiens - Amiens, France