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

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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