A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complete Response
研究概览
简要总结
This is a randomized, open-label, single-center clinical trial to compare the efficacy and safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related Disease. Patients will be followed for three months to measure the primary outcome and secondary outcomes.
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
- •Males and females
- •Age 18-70 years old with informed consent
- •Patients with IgG4-RD:
- •swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
- •elevated serum IgG4 (>1.35 g/L)
- •histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
- •exclusion of other diseases.
排除标准
- •Previously or currently received glucocorticoid and(or) immunomodulator
- •Pregnancy or lactating
- •Concurrent severe and/or uncontrolled and/or unstable diseases
- •Patient with malignancy
研究组 & 干预措施
Medium Dose
Patients are treated with prednisone or equivlent at doseage of 0.5-0.6 mg/kg/d (max 40mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.
干预措施: Prednisone (Drug)
High Dose
Patients are treated with prednisone or equivlent at doseage of 0.8-1.0 mg/kg/d (max 60mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.
干预措施: Prednisone (Drug)
结局指标
主要结局
Complete Response
时间窗: 3 months
Complete Response(CR) is defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies.
次要结局
- Disease Response(3 months)
- Adverse Effect(3 months)
研究者
Wen Zhang
Professor
Peking Union Medical College Hospital