Cohort Study of Patients With IgG4-Related Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Clinical Response
研究概览
简要总结
This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease.
详细描述
Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and elevated serum IgG4 concentration.
In this study, patients with IgG4-RD will be investigated, including clinical presentation, laboratory findings and imaging study. All patients will be treated by standard care and follow-uped for at least 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Age 18-75 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
- •Females planning to bear a child recently or with childbearing potential
- •Concurrent severe and/or uncontrolled and/or unstable diseases
- •Patient with malignancy
结局指标
主要结局
Clinical Response
时间窗: 6 months
Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.
次要结局
未报告次要终点
研究者
Wen Zhang
Professor
Peking Union Medical College Hospital