drugset / Trial / NCT05758831

RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

NCT05758831

Phase 3 Recruiting 386 enrolled Rennes University Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-06-01
Primary completion
2030-03-31
Completion
2030-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ocrelizumab Monoclonal antibody 300 mg Other
Subject Rituximab Monoclonal antibody 500 mg Other