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RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

NCT05758831 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2026-02-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Perfusion of treatment Rituximab

Perfusion of treatment (Mabthera®, Truxima®, Rixathon®, Ruxience®)

DRUG

Perfusion of treatment Ocrelizumab

Perfusion of treatment (Ocrevus®)

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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 NCT05758831 on ClinicalTrials.gov