A Prospective, Randomized Controlled Study to Compare the Efficacy and Safety of Baricitinib Combined With Glucocorticoid and Glucocorticoid Monotherapy in Proliferative IgG4-RD Patients With Eosinophilia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 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
Evaluation of efficacy and safety of Baricitinib combined with glucocorticoid in patients of IgG4-related disease with eosinophilia.
详细描述
This is a multicenter, 52-week prospective, randomized controlled study to compare the efficacy and safety of Baricitinib combined with glucocorticoid and glucocorticoid monotherapy in proliferative IgG4-RD patients with eosinophilia.
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
- •All patients must meet the following diagnostic criteria of IgG4RD (2020): 1) and radiological features: One or more organs show diffuse or localized swelling or a mass or nodule characteristic of IgG4-RD. In single organ involvement, lymph node swelling is omitted. 2) serological diagnosis: Serum IgG4 levels greater than 135 mg/dl. 3) diagnosis diagnosis: Positivity for two of the following three criteria: a. Dense lymphocyte and plasma cell infiltration with fibrosis. b. Ratio of IgG4-positive plasma cells /IgG-positive cells greater than 40% and the number of IgG4-positive plasma cells greater than 10 per high powered field. c. Typical tissue fibrosis, particularly storiform fibrosis, or obliterative phlebitis.
- •Patients fulfill (1) + (2) + (3) are diagnosed as definite IgD4RD; (1) + (2): possible IgG4RD; (1) + (3): probable IgG4RD. exclusion of other diseases.
- •Active IgG4-RD (Responder Index ≥ 2 points for each involved organ)
- •The counts of peripheral blood eosinophil cells ≥0.75×109/L
排除标准
- •Patients who is not able to discontinue GC
- •Pregnancy or breastfeeding or planning to get pregnant within 2 years
- •Received glucocorticoids, immunosuppressants, biological agents or JAK inhibitors within 3 months
- •Allergic to Baricitinib
- •Concomitant other autoimmune diseases
- •Chronic HBV infection, latent tuberculosis, or active infection
- •Server liver or renal dysfunction, or heart failure.
研究组 & 干预措施
Prednisolone monotherapy
Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.
干预措施: Prednisolone (Drug)
Prednisolone plus Baricitinib
Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months. Oral Baricitinib 2mg daily for 12 months.
干预措施: Prednisolone (Drug)
Prednisolone plus Baricitinib
Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months. Oral Baricitinib 2mg daily for 12 months.
干预措施: Baricitinib (Drug)
结局指标
主要结局
The difference of recurrent rate of IgG4-RD between the two groups
时间窗: 52 weeks
Clinical recurrence definition: any item of IgG4-RD Responder Index ≥2 (without treatment), or ≥ 3 (with treatment) or new organ involvement; with or without elevated serum IgG4 levels.
次要结局
- The changes of serum IgG levels(52 weeks)
- The changes of serum IgG4 levels(52 weeks)
- The changes of IgG4-related disease Responder Index(52 weeks)
- The changes of ESR(52 weeks)
- The percentages of adverse events(52 weeks)
- The results of High-throughput analysis(52 weeks)
- The changes of serum hsCRP level(52 weeks)
- The changes of PGA(52 weeks)
- The time of recurrence(0-52 weeks)
- The changes of blood Eosinophil cells(52 weeks)
研究者
Wen Zhang
Professor
Peking Union Medical College Hospital