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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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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