ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar

Launched by CELLTRION HEALTHCARE FRANCE · May 21, 2025

Keywords

ClinConnect Summary

The ROLL'YN-UST study is looking at how well a new treatment called Steqeyma®, a biosimilar to Ustekinumab, works for patients with Crohn's disease and plaque psoriasis. This is a real-life study, meaning it focuses on how patients feel and how effective the treatment is in everyday situations. To participate, individuals need to be at least 18 years old, have been diagnosed with either condition, and have been using the original Ustekinumab treatment for at least six months. They also need to be in a stable health condition for at least three months and have a doctor who agrees to switch their treatment to Steqeyma®.

Participants will be asked to complete surveys about their health and satisfaction with the treatment at six and twelve months after starting Steqeyma®. This study aims to understand how well patients maintain their health and how satisfied they are with their new treatment over the course of a year. It's important to note that only adults who meet specific criteria can join, and those who are pregnant or currently involved in other clinical trials are not eligible. If you or a loved one is considering participating, it could provide valuable insights into the effectiveness of this new treatment option.

Gender

ALL

Eligibility criteria

• 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.