Clinical Trial

RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

Study acronym: TRIO
Recruiting Phase 3
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Summary
The goal of this randomized clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main question it aims to answer is : • to demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the % of patients without disease activity at 2 years. During the 2 years, the study includes 6 follow-up visits and the completion of various health and quality of life questionnaires. The protocol visits follow the usual schedule of treatment infusions for the disease (at initiation of treatment, 15 days after, and then every 6 months). Two comparison groups: Researchers will compare rituximab treated patients versus ocrelizumab treated patients to see the % of patients without disease activity at 2 years.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-03-06; most recent amendment 2026-01-29.
Status change: Not Yet Recruiting → Recruiting 2023-08-08
Trial Details
NCT Number NCT05758831
Lead Sponsor Rennes University Hospital
Conditions Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis
Enrollment 386 participants
Start Date 2023-06-01
Primary Completion 2030-03-31 (estimated)
Study Completion 2030-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-02