RecruitingPhase 3NCT05758831

RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

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


Sponsor

Rennes University Hospital

Enrollment

386 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two medications — rituximab and ocrelizumab — in people with relapsing-remitting multiple sclerosis (MS) that is showing signs of activity. Both are antibody treatments that target a protein on immune cells thought to drive MS. **You may be eligible if...** - You have been diagnosed with relapsing-remitting MS (per 2017 McDonald criteria) - Your MS has shown signs of activity in the past year — either a relapse or a new lesion on MRI - You are between 18 and 55 years old - Your disability level is relatively low (EDSS score of 5 or less) - You have had a brain MRI within the past 6 months - If you can become pregnant, you are using effective contraception **You may NOT be eligible if...** - You have had prior treatment with rituximab, ocrelizumab, alemtuzumab, or similar powerful immune-modifying therapies - You have low B-cell counts, active infection, hepatitis B, or a recent live vaccine - You have severe liver disease or another serious medical condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPerfusion of treatment Rituximab

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

DRUGPerfusion 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

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NCT05758831


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