RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorRennes University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Patients presenting a relapsing remitting MS according to Mac Donald 2017 criteria, with clinical or radiological criteria of activity (ie at least one relapse AND/OR one new T2 lesion in the last 12 months before inclusion);
Age between 18 and 55 years
EDSS ≤ 5
Brain MRI within 6 months before inclusion
Disqualifiers
None
Trial design
Treatments tested in this trial
- Perfusion of treatment Rituximab
- Perfusion of treatment Ocrelizumab
Treatment groups
386 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov