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RECRUITING
NCT05758831
PHASE3

RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

Sponsor: Rennes University Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective Randomized Trial of Non-inferiority Comparing RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

386

Start Date

2023-06-01

Completion Date

2030-05-01

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DRUG

Perfusion of treatment Rituximab

Perfusion of treatment (Mabthera®, Truxima®, Rixathon®, Ruxience®)

DRUG

Perfusion of treatment Ocrelizumab

Perfusion of treatment (Ocrevus®)

Locations (23)

Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer

Lyon, Bron, France

CHRU de Brest - Hôpital la Cavale Blanche

Brest, France

Centre Hospitalier Universitaire de Caen

Caen, France

Centre Hospitalier de Pontoise - GHT NOVO

Cergy-Pontoise, France

Hôpital Gabriel Montpieds

Clermont-Ferrand, France

Centre hospitalier de Gonnesse

Gonesse, France

Groupe Hospitalier de l'Institut Catholique de Lille

Lille, France

Centre Hospitalier Universitaire de Limoges

Limoges, France

AP-HM - Hôpital la Timone

Marseille, France

CHRU de Montpellier - Hôpital Gui de Chauliac

Montpellier, France

Centre Hospitalier Régional de Nancy

Nancy, France

CHU de Nantes -Hôpital Nord Laennec

Nantes, France

CHU de Nice - Hôpital Pasteur 2

Nice, France

CHU de Nîmes - Hôpital Caremeau

Nîmes, France

AP-HP Höpital la Pitié-Salpétrière

Paris, France

Groupe Hospitalier Universitaire Henri Mondor

Paris, France

Hôpital Saint-Germain

Poissy, France

Centre Hospitalier de Cornouaille

Quimper, France

Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

Rennes, France

CHU de Rouen - Hôpital Charles Nicolle

Rouen, France

CHRU de Strasbourg - Hôpital Hautpierre

Strasbourg, France

Hôpital Foch

Suresnes, France

CHU de Toulouse - Bâtiment Pierre Paul Riquet

Toulouse, France