EUCTR2012-004436-36-DK进行中（未招募）1 期
A prospective pilotstudy of immunological and radiological effects of intrathecal rituximab in patients with secondary progressive multiple sclerosis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Clinical definate multiple sclerosis
- •Secondary progressive multiple sclerosis defines as no relaps within 1 year, and sustained progression more than 3 month
- •Disease duration >15 years
- •EDSS score 3-7 (both included)
- •No contrast enhancement on MRI
- •Presence of oligoclonal bands and increased intrathechal IgG index
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnancy and lactation
- •Positive anti-JC virus antibody
- •Treatment with Natalizumab within 6 month
- •Treatment with interferon-beta or glatiramer acetate within 3 month
- •Prior treatment with immunosupressant
- •Decreased leucocyte or platelet count
- •Decreased liver or kidneyfunction
- •B-cell deficiency (low IgA, IgG or IgM)
- •Implanted metal or devices that contraindicates MRI
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