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

Sponsor
Celltrion HealthCare France
Study ID
NCT06997055
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
May 30, 2025
Start date
Mar 17, 2025
Status verified
May 2025
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
225 participants (estimated)

Arms

  • Arm: CD group
    Switch from ustekinumab originator in patients with Crohn's disease
  • Arm: Psoriasis Group
    Switch from ustekinumab originator in patients with Plaque Psoriasis

Primary Outcome Measure

Maintenance of remission, 12 months after initiation of biosimilar treatment [ Time Frame: 12 months ]

Central Contacts

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