Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in Sjogren's Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Complete response rate
研究概览
简要总结
This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for Sjogren's syndrome patients with severe thrombocytopenia.
详细描述
This study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for the treatment of severe thrombocytopenia in Sjogren's syndrome patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.
- •Baseline platelet counts less than 30×109/L.
排除标准
- •Concomitant other systemic autoimmune diseases.
- •Other severe complications of Sjogren's syndrome.
- •Abnormal laboratory tests such as: white blood cell count <2.5x10^9/L, hemoglobin <80 g/L, AST/ALT >1.5 ULN, serum creatine > 1.5 mg/dL.
- •Received glucocorticoids, immunosuppressants, or biological agents within 3 months.
- •Active acute or chronic infections.
- •History of malignancy.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Prednisolone monotherapy
Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.
干预措施: Prednisolone (Drug)
Prednisolone plus Tacrolimus
Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. Oral tacrolimus 1-2mg twice daily for 12 weeks.
干预措施: Prednisolone (Drug)
Prednisolone plus Tacrolimus
Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. Oral tacrolimus 1-2mg twice daily for 12 weeks.
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Complete response rate
时间窗: week 12
Complete response (platelet counts \> 100×10\^9/L) rates at week 12.
次要结局
- Partial response rate(week 4, week 8 and week 12)
- ESSDAI improvement(week 12)
- ESSPRI improvement(week 12)
- Complete response rate(week 4 and week 8)
研究者
Wen Zhang
Prof.
Peking Union Medical College Hospital