TRIO: A prospective randomized Trial of non-inferiority comparing RItuximab versus Ocrelizumab in relapsing-remitting multiple sclerosis. - 35RC20_9812

CHU De Rennes0 个研究点目标入组 430 人开始时间: 2022年9月12日最近更新: 2024年7月22日

试验速览

暂无简介。

•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), - Having signed an informed consent form, - Patients covered with social insurance

•-Secondary or primary progressive MS;, -Incapacity to understand or sign the consent form;, -Contraindication to MRI, -Previous treatment by fingolimod or natalizumab in the last 4 weeks, -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, -Previous treatment by mitoxantrone, cladribine, alemtuzumab and anti CD20 therapies in the last two years;, -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;

发起方

CHU De Rennes