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

ConditionsCrohn Disease Plaque Psoriasis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorCelltrion HealthCare France

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial population

Adult dermatology or gastroenterology patients presenting a diagnosis for any of the following pathologies: * Crohn's Disease * Plaque Psoriasis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Ustekinumab 45 mg
Drug
biosimilar
Ustekinumab 90 mg
Drug
biosimilar

Treatment groups

225 Participants

are divided into 2 treatment groups

Group A: CD group2 interventions

Group B: Psoriasis Group2 interventions

Trial outcomes

Primary outcomes

Maintenance of remission, 12 months after initiation of biosimilar treatment

Percentage of patients still in clinical remission 12 months after initiation of biosimilar treatment according to the definitions used in the inclusion criteria.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Celltrion HealthCare France

Lead sponsor

Sanoia

Collaborator

Source ClinicalTrials.gov

Apply now