RECRUITINGOBSERVATIONAL
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
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Ustekinumab 45 mg
biosimilar
DRUG
Ustekinumab 90 mg
biosimilar
Locations (1)
CHU Amiens
Amiens, France