An Open-Label, Prospective, Single-arm, Multi-center Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab
概览
- 阶段
- 4 期
- 干预措施
- Ocrelizumab
- 疾病 / 适应症
- Multiple Sclerosis, Relapsing
- 发起方
- Genentech, Inc.
- 入组人数
- 179
- 试验地点
- 57
- 主要终点
- Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
Open-label, prospective, single-arm, multi-center study to assess disease activity and biomarker of neuronal damage in minority patients (self-identified Black or African American (AA) and Hispanic/Latino (HA) patients with relapsing multiple sclerosis (RMS) receiving treatment with Ocrelizumab. The study plans to enroll approximately 150 participants (75 AA and 75 HA) with 50 participants enrolled in a CSF sub-study.
研究者
入排标准
入选标准
- •Diagnosis of RMS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment
- •Participants who self-identify as Black or African American or Hispanic/Latino American
- •Treatment-naïve or initiating first or second switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethyl fumarate (DMF); or siponimod; or fingolimod; or diroximel fumarate; or teriflunomide; or ozanimod; or natalizumab
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab
- •Neurologically stable for at least 30 days prior to randomization and baseline assessments
排除标准
- •Diagnosis of secondary progressive MS without relapses for at least 1 year (nonactive or inactive SPMS)
- •Primary Progressive Multiple Sclerosis (PPMS)
- •Participants with contraindication to gadolinium based contrast agent for MRI and participants who cannot tolerate MRI procedure
- •Infection Related
- •Cancer Related
- •Pregnant or lactating, or intending to become pregnant during the study
- •Other Medical Conditions
- •Known presence or history of other neurologic disorders
- •Vaccinations: Receipt of a live vaccine, or attenuated, or inactivated / component vaccine within 6 weeks prior to first administration of ocrelizumab
- •Laboratory: abnormalities or findings at screening
研究组 & 干预措施
All Participants
Main study participants will be evaluated at baseline, monitored and followed for a 1 year period with the option to participate in a 1 year extension. Participants in the CSF substudy will be followed for two years and will receive two additional doses of 600 mg ocrelizumab at Weeks 48 and 72.
干预措施: Ocrelizumab
结局指标
主要结局
Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment
时间窗: 48 Weeks
A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain magnetic resonance imaging (MRI)
次要结局
- Time to onset of 24 weeks confirmed disability progression (CDP) at week 48(Week 48)
- Annualized relapse rate at week 48(Week 48)
- Time to protocol-defined event(Week 48)