Mechanism of Action of Ocrelizumab in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Complete Depletion of B Cells
研究概览
简要总结
Ocrelizumab is FDA approved for therapy of multiple sclerosis (MS). It depletes B cells and stops MS inflammation.
详细描述
The study will investigate immune cell subsets, and how the cells are modified by this therapy over a 1-year period in 25 subjects. Blood will be drawn at baseline, 2 weeks, 6 mo, and 12 mo.
Immune subsets will be analyzed by flow cytometry. Data are analyzed with ANOVA with repeated measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 是
入选标准
- •All patients who are eligible for Ocrelizumab therapy based on FDA criteria
排除标准
- •All patients who are ineligible for Ocrelizumab therapy based on FDA criteria.
- •Prior treatment with Alemtuzumab or stem cell therapy, or immune abnormalities that would interfere with planned tests.
- •Hepatitis B and HIV infections.
- •Pregnant or lactating women.
- •Hypersensitivity to trial medications.
研究组 & 干预措施
MS-ocrelizumab treated
ocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start
干预措施: ocrelizumab (Drug)
结局指标
主要结局
Number of Participants With Complete Depletion of B Cells
时间窗: 1 year
measured through lymphocyte surface marker stains, from patients, before and after ocrelizumab (Ocrevus) therapy Mononuclear cells (MNC) will be stained, for flow cytometry, with marker antibodies to B cells. The change in the percentage of each subset will be compared before and after treatment with paired t tests and ANOVA.
次要结局
未报告次要终点