Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Antigen microarrays
研究概览
简要总结
The purpose of this study is to assess effects of B cell depletion on the immune system in patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will be done by collecting blood from patients starting treatment with ocrelizumab before the first infusion and before the infusions at 6 and 12 months. The effects on the immune system will be assessed by performing transcriptome profiling of immune cells, measuring serum levels of microRNAs, and analyzing serum autoantibody immune signatures using antigen arrays. In addition, blood will be collected once from a group of healthy individuals to serve as controls.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS Center
- •Healthy controls
- •Ability to understand and sign informed consent
- •Exclusion Criteria - All subjects:
- •Other concomitant autoimmune or inflammatory diseases
- •Ongoing treatment with other immunomodulatory medications
- •Previous treatment with rituximab, methotrexate, cyclophosphamide, mitoxantrone, mycophenolate mofetil, or alemtuzumab
- •Pregnancy or lactation
- •Hypersensitivity to ocrelizumab
- •Exclusion Criteria - Healthy Controls:
- •First-degree relatives with MS
排除标准
- 未提供
结局指标
主要结局
Antigen microarrays
时间窗: 12 months
Changes in serum autoantibody immune signatures
Monocyte Transcriptome Profiling
时间窗: 12 months
Changes in messenger ribonucleic acid (mRNA) expression
Serum microRNA profiles
时间窗: 12 months
Changes in serum microRNA expression
次要结局
未报告次要终点
研究者
Howard L Weiner
Director, Partners Multiple Sclerosis Center; Co-Director, Ann Romney Center for Neurologic Diseases
Brigham and Women's Hospital