RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis. (TRIO)
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Relapsing-remitting
Eligibility Criteria
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.
Sites / Locations
- Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer
- CHRU de Brest - Hôpital la Cavale Blanche
- Centre Hospitalier Universitaire de Caen
- Centre Hospitalier de Pontoise - GHT NOVO
- Hôpital Gabriel Montpieds
- Centre hospitalier de Gonnesse
- Groupe Hospitalier de l'Institut Catholique de Lille
- Centre Hospitalier Universitaire de Limoges
- AP-HM - Hôpital la Timone
- CHRU de Montpellier - Hôpital Gui de Chauliac
- Centre Hospitalier Régional de Nancy
- CHU de Nantes -Hôpital Nord Laennec
- CHU de Nice - Hôpital Pasteur 2
- CHU de Nîmes - Hôpital Caremeau
- AP-HP Höpital la Pitié-Salpétrière
- Groupe Hospitalier Universitaire Henri Mondor
- Hôpital Saint-Germain
- Centre Hospitalier de Cornouaille
- Centre Hospitalier Universitaire de Rennes, Hôpital PontchaillouRecruiting
- CHU de Rouen - Hôpital Charles Nicolle
- CHRU de Strasbourg - Hôpital Hautpierre
- Hôpital Foch
- CHU de Toulouse - Bâtiment Pierre Paul Riquet
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Ocrelizumab
Rituximab
Day 0 (300mg), Day 15(300mg), and then 300 mg every 6 months (M6, M12, M18 and M24)
Day 0 (1000mg), Day 15 (1000 mg), and then 500 mg every 6 months (M6, M12, M18 and M24)