NCT05758831RecruitingPhase 3
RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.
A Prospective Randomized Trial of Non-inferiority Comparing RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 386 (estimated)
- First submitted
- 17 Feb 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 31 Mar 2030
- Lead sponsor
- Rennes University Hospital
- Diseases
- Multiple sclerosis
- NCT number
- NCT05758831
- EU CT number
- 2022-501027-25-01
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 386
- From 1 Jun 2023 to the primary completion date, 31 Mar 2030
- 26 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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 MRI within 6 months before inclusion
- For women of childbearing potential\*: effective contraception (effective contraception include oral contraception, intrauterine devices and other forms of contraception with failure rate \<1%, for the duration of the study and until 12 months after last dose administered) \* A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- Having signed an informed consent form
- Patients covered with social insurance
- Non-Inclusion Criteria:
- Secondary or primary progressive MS;
- Previous treatment by mitoxantrone, cladribine, alemtuzumab and anti CD20 therapies in the last two years;
- Previous treatment by fingolimod or natalizumab in the last 4 weeks;
- Treatment with high dose corticosteroids during the 30 days preceding the inclusion;
- Occurrence of a relapse less than 30 days before inclusion;
- Pregnancy or breastfeeding;
- Other neurologic or systemic disease;
- Concomitant participation or Participation in another therapeutic trial in the last 6 months;
- Incapacity to understand or sign the consent form;
- Contraindication to MRI;
- Contraindication to anti-CD20 therapies:
- Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization
- Active malignancy.
- Any ongoing infection
- Severe heart failure (New York Heart Association Class IV) or severe uncontrolled cardiac disease
- Positive test for HIV, hepatitis B or C, or tuberculosis
- Severe immune deficiency:
- Lymphopenia grade 3 (0.2 to 0.5 × 10\^9/L) or higher grades
- Neutropenia grade 3 (0.5 to 1.0 × 10\^9/L) or higher grades
- Known hypersensitivity or other known side effects for any of the study medications, including co-medications such as high glucocorticosteroids
- AST or ALT \>=3ULN
- Platelet (thrombocyte) count \< 100 x 10\^9/L
- Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Regional Et Universitaire De Brest Coordinator of this site? Confirm its status | Brest Cedex 2 | France | Active, not recruiting |
| Hospices Civils De Lyon Coordinator of this site? Confirm its status | Bron Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Active, not recruiting |
| Chu Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil Cedex | France | Active, not recruiting |
| Centre Hospitalier General Coordinator of this site? Confirm its status | Gonesse | France | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Limoges Coordinator of this site? Confirm its status | Limoges | France | Active, not recruiting |
| Groupement Des Hopitaux De L'Institut Catholique De Lille Coordinator of this site? Confirm its status | Lomme Cedex | France | Active, not recruiting |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Centre Hospitalier Régional Universitaire de Nancy Coordinator of this site? Confirm its status | Nancy | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Intercommunal De Poissy Saint Germain Coordinator of this site? Confirm its status | Poissy | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Active, not recruiting |
| Centre Hospitalier Rene Dubos Coordinator of this site? Confirm its status | Pontoise | France | Active, not recruiting |
| Centre Hospitalier Intercommunal De Cornouaille Coordinator of this site? Confirm its status | Quimper Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Active, not recruiting |
| CHU De Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Active, not recruiting |
| Groupe Hospitalier Rance Emeraude Coordinator of this site? Confirm its status | Saint-Malo Cedex | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Active, not recruiting |
| Hospital Foch Coordinator of this site? Confirm its status | Suresnes | France | Active, not recruiting |
| Hopital Purpan Coordinator of this site? Confirm its status | Toulouse | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.