2023-505420-62-00招募中3 期
For patients with active multiple sclerosis, impact of annual versus semi-annual infusions of ocrelizumab after 2 years of initial treatment on the absence of radiological disease activity at 2 years: a multicentre randomised controlled non-inferiority trial
Hopital Fondation Adolphe De Rothschild10 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2023年7月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 244
- 试验地点
- 10
- 主要终点
- Percentage of patients with no new or enlarged T2 lesion >3mm on cerebro-medullary MRI at 24 months compared to inclusion MRI
研究概览
简要总结
To compare the efficacy of a treatment plan with annual administrations of ocrelizumab versus a conventional treatment plan with semi-annual administrations, on the absence of radiological disease activity at 2 years, in patients with active MS treated for at least 2 years with ocrelizumab
研究设计
- 分配方式
- Randomized
- 主要目的
- Etude de non-infériorité de phase III multicentrique, randomisée contrôlée en ouvert
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient 18 years or older
- •Coming for a 4th semester cycle of ocrelizumab (at least)
- •Requires follow-up cerebral-medullary MRI as part of care
- •Who had relapsing remitting or secondarily progressive MS at the time of initiation of anti-CD20 (ocrelizumab or rituximab) therapy : relapse or radiological activity in the year priori to initiation of high-efficacy treatment
- •No relapse for at least 18 months
- •EDSS between 0 and 6 inclusive
- •Having received information about the study and having signed a consent to participate in the study
- •Knowledge of the French language
- •Affiliated or beneficiary to a social security scheme
排除标准
- •Clinical forms of primary progressive multiple sclerosis (PP)
- •Pregnant or breast-feeding woman
- •Patients already receiving routine spacing ≥ 9 months of ocrelizumab doses
- •Contra-indication to continued treatment with ocrelizumab (hypersensitivity reaction, ongoing active infection, development of a malgnant disease since the previous inhection, development of a severe immune deficiency)
- •Planning a pregnancy within 3 years
- •Contra-indication to MRI
- •Contra-indication to the injection of contrast products
- •Subjects with severe or uncontrolled symptoms of renal, hepatic, haematological, gastrointestinal, pulmonary, psychiatric or cardiac disease or any uncontrolled intercurrent disease
- •Patient under legal protection measure
- •Patients of childbearing potential who do not wish to use effective contraception during their participation and at least 12 months after the last dose (oral commitment of the patient recorded in the medical file by the investigator)
结局指标
主要结局
Percentage of patients with no new or enlarged T2 lesion >3mm on cerebro-medullary MRI at 24 months compared to inclusion MRI
Percentage of patients with no new or enlarged T2 lesion >3mm on cerebro-medullary MRI at 24 months compared to inclusion MRI
次要结局
- Relapse defined as the onset or worsening of symptoms, in the absence of fever, responsible for an increase of at least 0.5 points in the oberall EDSS score, or of 2 points in at least one functional systems of the EDSS, excluding sphincter and mental/cerebral scores
- Disability progression defined as an increase of >20% in Multpile Sclerosis Functional Composite (MSFC) score between inclusion and M24. Disability progression defined by an on-study increase in EDSS score of at least 1 point from baseline if EDSS at baseline was <6, or an increase of at least 0.5 points if EDSS at baseline was equal to 6
- Percentage of NEDA 3 patients at M24: NEDA 3 (No Evidence of disease activity) corresponds to the absence of radiological activity and clinical activity : absence of relapses and disability progression
- Percentage of patients with at least 3 new T2 lesions on cerebro-medullary MRI at 24 months compared to the inclusion MRI
- Number of new T2 lesions on cerebral-medullary MRI at 24 months compared to inclusion MRI
- Percentage of patients with no new or enlarged T2 lesion >3mm on cerebro-medullary MRI at 12 months compared to inclusion MRI
- Hypogammaglobulinemia defined as a value less than 6g/L
- Evolution of the gamma globulin level in plasma protein eletrophoresis between inclusion and M24
- Evolution of IgG assays between inclusion and M24.
- Evolution of IgM assays between inclusion and M24.
- Evolution of IgA assays between inclusion and M24.
- Evolution of CD19 lymphocyte counts between inclusion and M24
- Incidence of infectious events requiring treatment
- Incidence of cancer
研究者
Clinical research department
Scientific
Hopital Fondation Adolphe De Rothschild
研究点 (10)
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