Enhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in frequency of regulatory B cells
研究概览
简要总结
The purpose of this study is to investigate the immune cell and other factor changes with Ocrevus in Multiple Sclerosis (MS) patients. Researchers will recruit 35 participants for this study. Patients will be enrolled from the Multiple Sclerosis Center at the University of Michigan Health System in Ann Arbor. The goal of the study is to understand the role of regulatory B cell, T cell and other factors in mediating the therapeutic effects of Ocrevus.
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
- •Patients with MS either with relapsing or primary progressive course; who are newly starting on ocrelizumab (Ocrevus) at the time of enrollment
- •Healthy controls who do not have a significant medical conditions such as cancer, chronic infection, or autoimmune disease, have not taken steroids in the past 2 months, and who are not on an immune suppressant medication.
- •Ability to give informed consent
- •Willing to have blood drawn as scheduled in the protocol
- •Willing and able to complete all procedures and evaluations related to the study
排除标准
- •Medical or psychiatric conditions that may affect the patient's ability to give informed consent
- •Has received an experimental drug within 30 days of enrollment
- •Concomitant other disease modifying medications (such as Rebif, Betaseron, Avonex, Copaxone, Gilenya, Tecfidera, Aubagio, Mayzent, Mavenclad, Alemtuzumab, methotrexate, azathioprine, Novantrone, cyclophosphamide, cyclosporine, Tysabri, Rituxan, Ocrevus, etc.)
- •Has any contraindication to high-dose immunotherapy, including pregnancy, trying to become pregnant, or breast feeding during the study
- •Active hepatitis B virus infection
- •History of life-threatening infusion reaction to Rituxan or Ocrevus
- •Chronic infection or any severe acute infection within 3 months prior to screening
研究组 & 干预措施
Patients with MS
Patients with MS who have been newly prescribed Ocrevus
干预措施: Ocrelizumab (Drug)
结局指标
主要结局
Change in frequency of regulatory B cells
时间窗: From baseline to 24 months
Percentage B cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls
次要结局
- Change in frequency of T cell subtypes(From baseline to 24 months)
研究者
David A. Fox, MD
Professor of Rheumatology and Internal Medicine
University of Michigan