RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.
Recruiting
Phase 3
Interventional Study
Multiple Sclerosis
Relapsing-remitting Multiple Sclerosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 386 (estimated)
- Sponsor
- Rennes University Hospital · Other
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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 stud…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 MR…
Contacts