Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- Annualized relapse rate day 360
研究概览
简要总结
Neuromyelitis optica (NMO) is an autoimmune inflammatory demyelinating disease of the central nervous system that leads to blindness and paralysis. Since disability accrues incrementally related to attacks, attack prevention with immunosuppressive therapy is the mainstay of preventing disability. However, there is no standard immunosuppressive treatment strategy for NMO relapse prevention. In a previous study, the investigators provided evidence supporting the use of azathioprine plus a low dose corticosteroid as an effective strategy which is associated with a reduction in the risk of relapse in Chinese patients with NMO, but azathioprine has bone marrow suppression and other side effects. Mycophenolate mofetil (MMF) is a new immunosuppressant with rapid onset, fewer side effects and other advantages. In recent years, MMF has been used in different immune-related neurological diseases; some literature shown the possible efficacy of MMF in NMO treatment.
In this research, a multi-center (Third Affiliated Hospital of Sun Yat-sen University, Zhongshan Ophthalmic Centre of Sun Yat-sen University, Nangfang Hospital of Southern Medical University) study will carry out to evaluate the efficacy and safety of mycophenolate mofetil therapy in NMO spectrum disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the 2006 Wingerchuk diagnostic criteria;
- •NMO-immunoglobulin G seropositive;
- •Between 18 to 65 years old;
- •Relapse: more than 2 relapses in recent 2 years; more than 1 relapses in recent 1 years;
- •Expanded disability status scale: expanded disability status scale≤7.0, and visual acuity ≥20 / 100 at least in one eye
- •Understand the purpose and procedures of this study, and written informed consent is obtained.
排除标准
- •Using immunosuppressive agents and other drugs affect evaluation, and drug withdrawal less than 3 months;
- •Patients with any of the following diseases: transaminases elevation exceed 2 times of the normal upper limit; white blood cell <4 × 109 / L, Hemoglobin <80g / L, platelet <100 × 109 / L;
- •With serious cardiovascular, liver, kidneys and other vital organs and blood, endocrine system diseases, cancer history;
- •With immunodeficiency, uncontrolled infection and active gastrointestinal diseases (such as gastric ulcer, etc.);
- •Pregnancy, breast-feeding women and male or female who plans to conceive recently;
- •Allergy to mycophenolate mofetil and prednisone.
研究组 & 干预措施
Mycophenolate mofetil plus prednisone
Mycophenolate mofetil 500mg Bid and prednisone 10mg Qd
干预措施: Mycophenolate mofetil (Drug)
Mycophenolate mofetil plus prednisone
Mycophenolate mofetil 500mg Bid and prednisone 10mg Qd
干预措施: Prednisone (Drug)
结局指标
主要结局
Annualized relapse rate day 360
时间窗: day 360 after staring treatment
Patients come back for follow-up visit on day 360 after staring treatment, and annualized relapse rate was evaluated.
次要结局
- expanded disability status scale(day 1, 14, 30, 90, 180, 270, 360 after staring treatment)
- Hauser scale(day 1, 14, 30, 90, 180, 270, 360 after staring treatment)
- vision scale(day 1, 14, 30, 90, 180, 270, 360 after staring treatment)
- Lesions in brain and spinal cord(day 1, 14, 30, 90, 180, 270, 360 after staring treatment)
- Annualized relapse rate(day 1, 14, 30, 90, 180, 270 after staring treatment)
研究者
Wei Qiu
Associate Professor
Third Affiliated Hospital, Sun Yat-Sen University