NCT01325571已完成3 期
A Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid Therapy
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
- 83
- 主要终点
- Change from baseline in QMG score for disease severity
研究概览
简要总结
To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as myasthenia gravis (MG) by clinical diagnosis
- •QMG scores ≥7 at the time of enrollment
- •basic treatment drugs are mainly glucocorticoids, and the efficacy of glucocorticoid therapy was not sufficient
排除标准
- •receiving blood purification therapy or immunoglobulin therapy within 8 weeks before the study
- •QMG swallowing function score ≥ 2 points or QMG vital capacity = 3
- •abnormal hepatic functions
- •uncontrolled diabetes patients
- •hyperkalemia patients
- •immuno-inhibitors are forbidden due to malignancy, history of malignancy or history of HIV infection
- •patients who are allergic to Tacrolimus or macrolide antibiotics
- •receiving other immuno-inhibitors within 12 weeks
研究组 & 干预措施
tacrolimus group
Experimental
干预措施: Tacrolimus capsule (Drug)
placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in QMG score for disease severity
时间窗: Baseline and at 20 weeks
Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity
时间窗: Baseline and at 24 weeks
次要结局
- Changes in Osserman classification(Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks)
- Changes in myasthenia gravis activity of daily living scale(Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks)
研究者
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