Double-blind Randomized Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- INCAT sensory score at 1 year
研究概览
简要总结
Polyneuropathy associated with anti-MAG monoclonal IgM gammopathy is responsive of mainly a sensory deficit in predominantly males ,aged 40-70 years. Significantly high serum anti-MAG antibodies are linked with demyelinating features of the peripheral nerves.Rituximab, an anti-CD 20 monoclonal antibody is a new drug which reduces B-lymphocytes. This study will test the safety and efficacy of rituximab in the treatment of patients with anti-MAG polyneuropathy.
详细描述
Acting of a polyneuropathy for which there is not any treatment of reference today (see supra), a test of double-knowledge versus placebo is justified. Acting of a chronic polyneuropathy, the clinical evaluation must be led over one one year period. Acting of a sensitive polyneuropathy and the awaited benefit being the IMPROVEMENT OF the CLINICAL SIGNS, the principal criterion is a sensitive score in addition validated in chronic sensitive polyneuropathies immunodeficiency syndrome.
The patients answering the criteria of inclusion and none inclusion (see V-2) will be randomized in 2 groups: the first group will receive a perfusion IV of rituximab to the amount of 375 mg/m2 of body surface, once per week, during 4 weeks (see VII-3); the second group will receive 4 perfusions IV of placebo according to same methods'. The evaluation (see VI-1) will be carried out at the time of the randomization, then repeated in 3 months, 6 months, 9 months and 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgM monoclonal gammopathy
- •Anti-MAG antibody titers > 1.1000 BTU (ELISA)
- •Worsening polyneuropathy with INCAT score > 4
- •Informed consent
排除标准
- •Severe comorbidity
- •Other concurrent causes of polyneuropathy
- •Concurrent immunosuppressive therapies (wash-out > 3 months)
- •Previous treatment with rituximab
- •Lymphoproliferative disease indicating other immunosuppressive treatment
- •Unability to follow-up
- •Previous documented side-effects with components involved in the tested drug
- •White cell count < 1500/mm3 or platelet count < 75.000/mm3
- •Patient under law
研究组 & 干预措施
1
Rituximab
干预措施: Rituximab (Drug)
结局指标
主要结局
INCAT sensory score at 1 year
时间窗: during de study
INCAT sensory score at 1 year
次要结局
- Functional scales, MRC score(during the study)
- Quality of life (SF 36)(during the study)
- Serum lymphocytes count, IgM level, anti-MAG antibody titers(during the study)
- Electrophysiological parameters(during the study)