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.
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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

Laure MICHEL, MD

0299286774

laure.michel@chu-rennes.fr

CONTACT

Agnès Gazzola

0299289194

agnes.gazzola@chu-rennes.fr

CONTACT