Characteristic Study on Chinese Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The recurrence of NMO or MS
研究概览
简要总结
Compared with MS in white populations, in people of China descent multiple sclerosis (MS)is characterized by lower prevalence, more frequent and severe involvement of the visual system at onset and during the entire clinical course, more common occurrence of optic and spinal involvement, relatively rapid progression and less common occurrence of a progressive course. Data are not available for mainland China that are focused on characteristic studies of MS. In this study, the investigators sought to explore the characteristics of MS among Chinese in China, by conducting a study on genetics, pathogenesis, pathology, neuroimaging characteristics, and so on. Based on these data, the investigators try to explore the difference in neuromyelitis optical (NMO) and MS and provide clinical data for treatment guidelines for NNO and MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria for neuromyelitis optical
- •Optic neuritis
- •Acute myelitis
- •At least two of three supportive criteria:
- •Contiguous spinal cord MRI lesion extending over >= 3 vertebral segments
- •Brain MRI not meeting diagnostic criteria for multiple sclerosis
- •NMO-IgG seropositive status
- •Criteria for multiple sclerosis:
- •Two or more attacks; objective clinical evidence of two or more lesions, OR
- •Two or more attacks; objective clinical evidence of one lesion, dissemination in space, demonstrated by: MRI or two or more MRI-detected lesions consistent with MS plus positive CSF or wait further clinical attack implicating a different site, OR
- •One attack; objective clinical evidence of two or more lesions, dissemination in time, demonstrated by: MRI or second clinical attack, OR
- •One attack; objective clinical evidence of one lesion (monosymptomatic presentation; clinically isolated syndrome), dissemination in space, demonstrated by: MRI or two or more MRI-detected lesions consistent with MS plus positive CSF and dissemination in time, demonstrated by: MRI or second clinical attack, OR
- •Insidious neurological progression suggestive of MS, one year of disease progression (retrospectively or prospectively determined) and two of the following:
- •Positive brain MRI (nine T2 lesions or four or more T2 lesions with positive VEP)
- •Positive spinal cord MRI (two focal T2 lesions)
- •Positive CSF
排除标准
- •> 65 yrs old
- •Heavy damage of heart, lung, liver, renal function
- •Late neuromyelitis optical or EDSS > 6.0
- •Serious hypertension and diabetes
- •Serious mental disorders and depression
- •Allergic to drug: atorvastatin, β-interferon, EPO, immunoglobulin
研究组 & 干预措施
Atorvastatin, β-interferon, EPO
干预措施: atorvastatin (Drug)
Atorvastatin, β-interferon, EPO
干预措施: β-interferon (Drug)
Atorvastatin, β-interferon, EPO
干预措施: EPO (Drug)
结局指标
主要结局
The recurrence of NMO or MS
时间窗: 1 year
次要结局
- EDSS scores, active lesion detected by MRI(1 year)