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Recruiting Phase 3

RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

NCT05758831 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2023-06-01
Last updated
2026-02-02

Condition(s) studied

Multiple SclerosisRelapsing-remitting Multiple Sclerosis

Investigational drug(s) / intervention(s)

Perfusion of treatment RituximabPerfusion of treatment Ocrelizumab

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

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: * 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.

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)

FacilityCityRegionStatus
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
Official registry record

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