2022-501027-25-01招募中4 期
TRIO: A prospective randomized Trial of non-inferiority comparing RItuximab versus Ocrelizumab in relapsing-remitting multiple sclerosis.
CHU De Rennes25 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2022年12月2日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 430
- 试验地点
- 25
- 主要终点
- % 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
研究概览
简要总结
To demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the % of patients without disease activity at 2 years.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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;
结局指标
主要结局
% 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
% 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
次要结局
- Clinical criteria - Relapses: annualized relapse rate, mean time of onset of the first relapse, % of patients without relapse at M24, - Disability progression: % of patients without disability progression at M24 Disability progression will be defined as an increase of 1.5 pt if baseline EDSS=0, 1pt EDSS (if baseline 1 ≤ EDSS<6), or an increase of 0.5pt if baseline EDSS is ≥ 6; confirmed at 6 months. MRI Criteria - Mean number of Gd enhancing lesions at M6; - % of patients with at least one Gd
- MRI Criteria - Mean number of Gd enhancing lesions at M6; - % of patients with at least one Gd enhancing lesion(s) at M6; - Mean number of new or enlarging brain T2 lesion from M6 to M24; % of patients with one or more new or enlarging brain T2 lesions from M6 to M24;
- Quality of life - Change in the EQ5D-5L score from baseline to every six month of follow up until M24 - Change in the MusiQOL score from baseline to M12 and baseline to M24.
- Patients experience - Change in the Musicare score from baseline to M12 and baseline to M24.
- Medico-economic Incremental Cost-Effectiveness Ratio (ICER) defined as the cost for QALY gained in “ocrelizumab group” versus “rituximab group” at 24 months.
- Safety - The number of each adverse event and number of severe adverse events will be compared between the two groups.
研究者
Laure Michel
Scientific
CHU De Rennes
研究点 (25)
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