Actively Recruiting
RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.
Led by Rennes University Hospital · Updated on 2026-02-02
386
Participants Needed
23
Research Sites
360 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with relapsing-remitting MS according to Mac Donald 2017 criteria, showing clinical or radiological activity (at least one relapse and/or one new T2 lesion) in the last 12 months before joining
- Age between 18 and 55 years
- Expanded Disability Status Scale (EDSS) score of 5 or less
- Brain MRI performed within 6 months before joining
- Women of childbearing potential must use effective contraception during the study and for 12 months after the last dose
- Signed informed consent form
- Covered by social insurance
You will not qualify if you...
- Secondary or primary progressive MS
- Treatment with mitoxantrone, cladribine, alemtuzumab, or anti-CD20 therapies in the last two years
- Treatment with fingolimod or natalizumab in the last 4 weeks
- High-dose corticosteroid treatment within 30 days before joining
- Relapse within 30 days before joining
- Pregnancy or breastfeeding
- Other neurological or systemic diseases
- Participation in another therapeutic trial within the last 6 months
- Inability to understand or sign the consent form
- Contraindications to MRI
- Contraindications to anti-CD20 therapies, including recent live vaccine, active cancer, ongoing infection, severe heart failure or uncontrolled cardiac disease, positive tests for HIV, hepatitis B or C, or tuberculosis, severe immune deficiency, certain blood count abnormalities
- Known hypersensitivity or side effects to study medications or related treatments
- Elevated liver enzymes (AST or ALT ≥3 times the upper limit of normal)
- Low platelet count (less than 100 x 10^9/L)
- Adults under judicial protection, guardianship, or deprived of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer
Lyon, Bron, France, 69677
Not Yet Recruiting
2
CHRU de Brest - Hôpital la Cavale Blanche
Brest, France, 29609
Not Yet Recruiting
3
Centre Hospitalier Universitaire de Caen
Caen, France, 14033
Actively Recruiting
4
Centre Hospitalier de Pontoise - GHT NOVO
Cergy-Pontoise, France, 95300
Not Yet Recruiting
5
Hôpital Gabriel Montpieds
Clermont-Ferrand, France, 63003
Not Yet Recruiting
6
Centre hospitalier de Gonnesse
Gonesse, France, 95503
Not Yet Recruiting
7
Groupe Hospitalier de l'Institut Catholique de Lille
Lille, France, 59160
Not Yet Recruiting
8
Centre Hospitalier Universitaire de Limoges
Limoges, France, 87042
Not Yet Recruiting
9
AP-HM - Hôpital la Timone
Marseille, France, 13385
Actively Recruiting
10
CHRU de Montpellier - Hôpital Gui de Chauliac
Montpellier, France, 34295
Actively Recruiting
11
Centre Hospitalier Régional de Nancy
Nancy, France, 54035
Actively Recruiting
12
CHU de Nantes -Hôpital Nord Laennec
Nantes, France, 44800
Actively Recruiting
13
CHU de Nice - Hôpital Pasteur 2
Nice, France, 06002
Actively Recruiting
14
CHU de Nîmes - Hôpital Caremeau
Nîmes, France, 30029
Not Yet Recruiting
15
AP-HP Höpital la Pitié-Salpétrière
Paris, France, 75010
Not Yet Recruiting
16
Groupe Hospitalier Universitaire Henri Mondor
Paris, France, 94000
Not Yet Recruiting
17
Hôpital Saint-Germain
Poissy, France, 78303
Not Yet Recruiting
18
Centre Hospitalier de Cornouaille
Quimper, France, 29107
Actively Recruiting
19
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
Rennes, France, 35000
Actively Recruiting
20
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France, 76038
Not Yet Recruiting
21
CHRU de Strasbourg - Hôpital Hautpierre
Strasbourg, France, 67200
Actively Recruiting
22
Hôpital Foch
Suresnes, France, 92150
Not Yet Recruiting
23
CHU de Toulouse - Bâtiment Pierre Paul Riquet
Toulouse, France, 31059
Not Yet Recruiting
Research Team
L
Laure MICHEL, MD
CONTACT
A
Agnès Gazzola
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here