Study of Combinative Effect of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Patients With Aggressive Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Number of MS Plaques Found on Brain MRI
研究概览
简要总结
The purpose of this study is to compare the effect of combinative induction therapy with mitoxantrone and plasmapheresis versus induction therapy with mitoxantrone alone in cases of aggressive multiple sclerosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aggressive multiple sclerosis in attack phase
- •EDSS: 1-5
- •No contraindication for mitoxantrone prescription
- •No past history of mitoxantrone injection
- •No history of corticosteroid and immunosuppressive therapy in last 3 months
排除标准
- •Patient's incompliance
- •Severe drug induced side effects
研究组 & 干预措施
mitoxantrone and plasmapheresis
Monthly Plasmapheresis (plasma exchange machine: Haemonetics, model TCS2, USA) 25 ml/kg for 5 cycles, with replacement of 0.9% saline and 5% human serum albumin followed by monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) at the end of each Plasmapheresis course for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.
干预措施: plasmapheresis (Procedure)
mitoxantrone
Monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.
结局指标
主要结局
Change From Baseline in Mean Number of MS Plaques Found on Brain MRI
时间窗: Month 8 after treatment initiation
Change From Baseline in Mean Number of MS plaques found on Brain MRI 8 months after treatment initiation
Expanded Disability Status Score
时间窗: At the end of month 8 after treatment initiation
The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and defines functional systems as pyramidalm, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral and others. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
次要结局
未报告次要终点
研究者
Masoud Etemadifar
Professor of neurology
Isfahan University of Medical Sciences