PACTR202103563404333招募中4 期
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.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
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
研究者
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