NCT03715699Unknown不适用
Leflunomide Treatment for IgG4-RD
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Response of Leflunomide treatment for IgG4-RD
研究概览
简要总结
This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid.
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
Group 1
Experimental
Patients treated with single glucocorticoid
干预措施: Prednisone (Drug)
Group 1
Experimental
Patients treated with single glucocorticoid
干预措施: Prednisone and Leflunomide (Drug)
Group 2
Experimental
Patients treated with Leflunomide and glucocorticoid
干预措施: Prednisone (Drug)
Group 2
Experimental
Patients treated with Leflunomide and glucocorticoid
干预措施: Prednisone and Leflunomide (Drug)
结局指标
主要结局
Response of Leflunomide treatment for IgG4-RD
时间窗: 1 year
Complete response rate; Partial response rate; No response
次要结局
- Relapse of Leflunomide treatment for IgG4-RD(1 year)
研究者
Wen Zhang
Professor
Peking Union Medical College Hospital
研究点 (1)
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