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

NCT06997055 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2025-05-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ustekinumab 45 mg

biosimilar

DRUG

Ustekinumab 90 mg

biosimilar

Sponsors & Collaborators

  • Sanoia

    collaborator OTHER

  • Celltrion HealthCare France

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06997055 on ClinicalTrials.gov