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RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

Study acronym: TRIO
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Site details revised at 8 of 23 sitesv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 28, 2023 to Jun 1, 2023
    • Site details revised at 23 of 23 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05758831
Lead Sponsor Rennes University Hospital
Conditions
(from sponsor)		 Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis
Related terms Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Enrollment 386 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov