RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.
Condition(s) studied
Investigational drug(s) / intervention(s)
Perfusion of treatment Rituximab: Perfusion of treatment (Mabthera®, Truxima®, Rixathon®, Ruxience®)
Perfusion of treatment Ocrelizumab: Perfusion of treatment (Ocrevus®)
Study 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
Primary outcome measure(s)
- To demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the percentage of patients without disease activity at 2 years. — at 2 years
Percentage of patients without disease activity at 2 years (Disease activity is defined as: * At least one relapse between baseline and M24 * OR MRI activity defined as Gd enhancing lesions at M6 or as the appearance of at least one new T2 lesion between M6 and M24)
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer | Lyon | Bron | Not Yet Recruiting |
| CHRU de Brest - Hôpital la Cavale Blanche | Brest | France | Not Yet Recruiting |
| Centre Hospitalier Universitaire de Caen | Caen | France | Recruiting |
| Centre Hospitalier de Pontoise - GHT NOVO | Cergy-Pontoise | France | Not Yet Recruiting |
| Hôpital Gabriel Montpieds | Clermont-Ferrand | France | Not Yet Recruiting |
| Centre hospitalier de Gonnesse | Gonesse | France | Not Yet Recruiting |
| Groupe Hospitalier de l'Institut Catholique de Lille | Lille | France | Not Yet Recruiting |
| Centre Hospitalier Universitaire de Limoges | Limoges | France | Not Yet Recruiting |
| AP-HM - Hôpital la Timone | Marseille | France | Recruiting |
| CHRU de Montpellier - Hôpital Gui de Chauliac | Montpellier | France | Recruiting |
| Centre Hospitalier Régional de Nancy | Nancy | France | Recruiting |
| CHU de Nantes -Hôpital Nord Laennec | Nantes | France | Recruiting |
| CHU de Nice - Hôpital Pasteur 2 | Nice | France | Recruiting |
| CHU de Nîmes - Hôpital Caremeau | Nîmes | France | Not Yet Recruiting |
| AP-HP Höpital la Pitié-Salpétrière | Paris | France | Not Yet Recruiting |
| Groupe Hospitalier Universitaire Henri Mondor | Paris | France | Not Yet Recruiting |
| Hôpital Saint-Germain | Poissy | France | Not Yet Recruiting |
| Centre Hospitalier de Cornouaille | Quimper | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou | Rennes | France | Recruiting |
| CHU de Rouen - Hôpital Charles Nicolle | Rouen | France | Not Yet Recruiting |
| CHRU de Strasbourg - Hôpital Hautpierre | Strasbourg | France | Recruiting |
| Hôpital Foch | Suresnes | France | Not Yet Recruiting |
| CHU de Toulouse - Bâtiment Pierre Paul Riquet | Toulouse | France | Not Yet Recruiting |
More Rennes University Hospital trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05758831 on ClinicalTrials.gov ↗ ← All trials in France