A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,300
- 试验地点
- 433
- 主要终点
- Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0
研究概览
简要总结
This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation
- •For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet
排除标准
- •Concurrent participation in any clinical trial (other than the Parent study)
- •Unable or unwilling to comply with the requirements of the protocol
研究组 & 干预措施
Ocrelizumab
Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046). Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.
干预措施: Ocrelizumab (Drug)
结局指标
主要结局
Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0
时间窗: Up to 44 months
次要结局
- The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume(Week 0, 24, 48, 72, 96, 120, 168)
- Change in 9-Hole Peg Test (9HPT) over time(Week 0, 24, 48, 72, 96, 120, 168)
- The number of T1 lesions and number of new or enlarging T2 lesions(Week 0, 24, 48, 72, 96, 120, 168)
- Change in Timed 25-Foot Walk Test (T25FWT) over time(Week 0, 24, 48, 72, 96, 120, 168)
- Change in Expanded Disability Status Scale (EDSS) score over time(Week 0, 24, 48, 72, 96, 120, 168)