2023-505974-14-00招募中3 期
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
- 招募中
- 入组人数
- 807
- 试验地点
- 108
- 主要终点
- 1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
研究概览
简要总结
To evaluate the longer-term safety of ocrelizumab in participants diagnosed with MS who were previously enrolled in Roche-sponsored Phase III pivotal studies
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Single Arm
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
次要结局
- 1. Change in Expanded Disability Status Scale (EDSS) score over time
- 2. Change in 9-Hole Peg Test (9HPT) and Timed 25-Foot Walk Test (T25FWT) over time
- 3. The number of new, hypointense T1 lesions and number of new or enlarging T2 lesions
- 4. The change in total volume of T2 lesions and in total T1 lesion volume
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (108)
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