NCT00309088已完成3 期
FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.]
研究概览
简要总结
The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed as myasthenia gravis
- •Those whose MG symptoms are well-controlled by the treatment with prednisone
- •Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain
排除标准
- •Those who have thymoma or the history of thymoma (Masaoka stage III or IV)
- •Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug
- •Patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug.
- •Patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug.
- •Pancreatitis or diabetes
- •Serum creatinine≦1.5mg/dL
研究组 & 干预措施
1
Experimental
干预措施: tacrolimus (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.]
时间窗: 6 Months
次要结局
- Success rate of achievement to the targeted steroid dose(6 Months)
- Total amount of steroid therapy (mg)(6 Months)
- QMG score;MG-ADL(6 Months)
研究者
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