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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Amiens
RECRUITING
Amiens
Contact Information
Primary
Salim BENKHALIFA, MD
etudescliniques_fr@celltrionhc.com
+33 1 71 25 27 00
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 225
Treatments
CD group
Switch from ustekinumab originator in patients with Crohn's disease
Psoriasis Group
Switch from ustekinumab originator in patients with Plaque Psoriasis
Sponsors
Collaborators: Sanoia
Leads: Celltrion HealthCare France

This content was sourced from clinicaltrials.gov