Comparison of Short-term Glucocorticoid Monotherapy and Short-term Glucocorticoid Combined with Mycophenolate Mofetil in the Treatment of IgG4 Related Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- The difference of recurrent rate of IgG4-RD between the two groups
研究概览
简要总结
Comparison of short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease
详细描述
This is a monocenter, 72-week prospective, randomized controlled study to compare short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old;
- •All patients must meet the comprehensive diagnostic criteria of IgG4-RD revised in Japan in 2020 or the classification criteria of IgG4-RD formulated by ACR/EULAR in 2019;
- •Active IgG4-RD (at least one organ has an IgG4-RD reaction score >=2 at the time of enrollment.)；
- •No previous medication or recurrence after withdrawal.
排除标准
- •Combined with other autoimmune diseases as the main diagnosis.
- •Pregnant or lactating women
- •Patients with malignant tumor
- •Active bacterial, fungal, viral or mycobacterial infections.
- •Severe complications of important organs, and the expected survival time is less than 6 months.
研究组 & 干预措施
short-term glucocorticoid monotherapy
Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months.
干预措施: prednison (Drug)
short-term glucocorticoid combined with Mycophenolate mofetil
Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months. Oral Mycophenolate mofetil 0.75g bid for 6 months.
干预措施: prednison (Drug)
short-term glucocorticoid combined with Mycophenolate mofetil
Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months. Oral Mycophenolate mofetil 0.75g bid for 6 months.
干预措施: Mycophenolate mofetil (Drug)
结局指标
主要结局
The difference of recurrent rate of IgG4-RD between the two groups
时间窗: 72 weeks
Clinical recurrence definition: any item of IgG4-RD Responder Index \>=2 points; Recurrence of previously involved organs or involvement of new organs; With or without elevated serum IgG4 levels.
次要结局
- The time of recurrence(0-72 weeks)
- The changes of IgG4-related disease Responder Index(72 weeks)
- The changes of serum IgG4 levels(72 weeks)
- The percentages of adverse events(72 weeks)
- The changes of PGA(72 weeks)
- The difference of remission rate of IgG4-RD between the two groups(72 weeks)
研究者
Wen Zhang
Professor
Peking Union Medical College Hospital