RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

Sponsor
Rennes University Hospital
Study ID
NCT05758831
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Perfusion of treatment Rituximab — DRUG
    Perfusion of treatment (Mabthera®, Truxima®, Rixathon®, Ruxience®)
  • Perfusion of treatment Ocrelizumab — DRUG
    Perfusion of treatment (Ocrevus®)

Study Details

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.

Key Dates

Start date
Jun 1, 2023
Status verified
Jan 2026
Primary completion
Mar 31, 2030
Completion
May 1, 2030

Study Design

Enrollment
386 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ocrelizumab
    Day 0 (300mg), Day 15(300mg), and then 300 mg every 6 months (M6, M12, M18 and M24)
  • Experimental: Rituximab
    Day 0 (1000mg), Day 15 (1000 mg), and then 500 mg every 6 months (M6, M12, M18 and M24)

Primary Outcome Measure

To demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the percentage of patients without disease activity at 2 years. [ Time Frame: at 2 years ]

Central Contacts

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