Leflunomide Treatment for IgG4-RD

Peking Union Medical College Hospital1 个研究点分布在 1 个国家目标入组 70 人2018年7月1日

适应症Autoimmune Disease

干预措施Prednisone Prednisone and Leflunomide

概览

阶段: 不适用
干预措施: Prednisone
疾病 / 适应症: Autoimmune Disease
发起方: Peking Union Medical College Hospital
入组人数: 70
试验地点: 1
主要终点: Response of Leflunomide treatment for IgG4-RD
最后更新: 7年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2018年7月1日

结束日期

2020年12月31日

最后更新

7年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Peking Union Medical College Hospital

责任方

Principal Investigator

主要研究者

Wen Zhang

Professor

Peking Union Medical College Hospital

入排标准

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.