A Randomized Trial of Treatment in Patients With IgG4-Related Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Complete and partial response rate at 3, 6, 9 and 12 months.
研究概览
简要总结
This is an open-label randomized controlled trial to compare the efficacy of Prednisone alone and combination therapy of Prednisone and Mycophenolate mofetil in IgG4RD patients.
详细描述
Patients with IgG4-RD will be randomized in two therapeutic groups: Prednisone alone and combination therapy with Prednisone and Mycophenolate mofetil. These patients will be followed in 12 months. Treatment response and relapse will be recorded, as well as side effects.
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
- •Aged 18 to 70 years old with informed consent
- •All patients must meet the following diagnostic criteria of IgG4RD (2011):
- •swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, 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). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD;
- •exclusion of other diseases.
排除标准
- •Patients will not be included if meets any of the following criteria:
- •Patients who were diagnosed as other autoimmune diseases;
- •Patients who were diagnosed as malignant diseases;
- •Pregnant and lactating women；
- •Active infection: HIV, HCV, HBV, TB；
- •Serious organ function failure, expected life time less than 6 months.
- •Presenting with Mikulicz disease without other manifestations.
研究组 & 干预措施
Prednisone
Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.
干预措施: Prednisone (Drug)
Prednisone and Mycophenolate mofetil
Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.
Immunosuppressive drugs: Mycophenolate mofetil 1g/d-1.5g/d for 6 months and 0.5/d-1.0g/d for 6 months.
干预措施: Prednisone and Mycophenolate mofetil (Drug)
结局指标
主要结局
Complete and partial response rate at 3, 6, 9 and 12 months.
时间窗: Up to 12 months
Complete and partial response are defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies
次要结局
- Number of participants with adverse effect(Up to 12 months)
- Disease response at 3, 6, 9 and 12 months.(Up to 12 months)
研究者
Wen Zhang
Professor
Peking Union Medical College Hospital