A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,055
- 试验地点
- 159
- 主要终点
- Mean change from inclusion in parent study in EDSS score over the course of the treatment
研究概览
简要总结
This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).
详细描述
This is a single arm, open label, multicenter extension study in participants who completed treatment period with ocrelizumab in the Roche P-trials. Participants will receive treatment with ocrelizumab as single 600 mg infusions every 24 weeks for two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •Able to comply with the study protocol, in the investigator's judgment
- •Completed the treatment period of Roche sponsored ocrelizumab P-trials
排除标准
- •Hypersensitivity to ocrelizumab or to any of its excipients.
- •Participantss in a severely immunocompromised state until the condition resolves.
- •Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation.
- •Existence of a contra-indication as per SmPC
- •Prohibited concomitant medication as specified in protocol
- •Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study
研究组 & 干预措施
Ocrelizumab
Participants will receive a single 600-mg infusion of Ocrelizumab every 24 weeks up to Week 72 of this study.
干预措施: Ocrelizumab (Drug)
结局指标
主要结局
Mean change from inclusion in parent study in EDSS score over the course of the treatment
时间窗: Up to 2 years
Time to onset of CDP sustained for at least 24 weeks and for at least 48 weeks
时间窗: Up to 2 Years
Percentage of participants who have confirmed disability improvement (CDI), CDP for at least 24 weeks and for at least 48 weeks yearly and over the duration of the treatment
时间窗: Up to 2 years
Percentage of participants who have improved, stable or worsened disability compared with baseline
时间窗: Up to 2 years
Improved, stable or worsened disability is measured by expanded disability status scale (EDSS) (annually/by epoch and over duration of the study) Stable EDSS is defined as EDSS change +/- 0.5. Worsening is \> 0.5 increase of EDSS, Improvement is \>0.5 decrease of EDSS
Time to 20% increase in timed 25-foot walk test (T25FWT)
时间窗: Up to 2 years
Time to 20% increase in timed nine-hole peg test (9HPT) sustained for at least 24 weeks and for at least 48 weeks, and proportion of patients achieving a sustained increase assessed yearly and at the end treatment
次要结局
- Time to first protocol-defined event of disease activity(Up to 2 Years)
- Time to first relapse(Up to 2 Years)
- Annualized relapse rate(Up to 2 Years)
- Percentage of participants relapse free, yearly and over the course of the treatment(Up to 2 Years)
- Percentage of participants with no evidence of protocol-defined disease activity (NEDA) yearly and over the duration of the treatment(Up to 2 Years)
- Percentage of participants with no evidence of progression (NEP)(Up to 2 Years)
- Total number of new and/or enlarging T2 lesion as detected by brain MRI over time(Up to 2 Years)
- Change in total T1 hypointense lesion volume over time(Up to 2 Years)
- Presence and evolution of leptomeningeal follicles as detected by MRI(Up to 2 Years)
- Percentage of participants with no evidence of progression sustained for at least 24 weeks and no active disease (NEPAD)(Up to 2 Years)
- Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT)(Up to 2 Years)
- Total number of T1 Gd-enhancing lesions as detected by brain MRI over time(Up to 2 Years)
- Participant reported outcomes: SymptoMScreen Score(Up to 2 Years)
- Participant reported outcomes: Quality of life (QoL) (Multiple Sclerosis Impact Scale [MSIS]-29)(Up to 2 Years)
- Percentage of Participants with Adverse Events(Up to 2 Years)
- Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time(Up to 2 Years)
- Change in brain volume (grey and white matter) as detected by brain MRI over time(Up to 2 Years)
- Time to treatment discontinuation/switch(Up to 2 Years)
- Participant reported outcomes: Employment status (Work Productivity and Activity Impairment Questionnaire [WPAI])(Up to 2 Years)
- Total number of FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period(Up to 2 years)