To Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild Symptom
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The change of IgG4-RD responder index before treatment and after treatment
研究概览
简要总结
30 untreated IgG4 related disease (IgG4-RD) patients with mild symptom are enrolled in this study, and will be treated with one dose of diprospan,then take Iguratimod 25mg, Bid orally. Patient's peripheral blood will be collected at baseline, 12 weeks and 24 weeks of follow up. The clinical efficacy will be evaluated by the IgG4-RD responder index, serum immunoglobulin, IgG4 and IgE, cytokines, and peripheral blood T cell and B cell sub-populations will be measured at baseline and follow up.
详细描述
Glucocorticoid is the recognized first-line medication for IgG4-RD, but it has many side effects. In order to avoid long time glucocorticoids intake, patients with mild disease will be treated with Iguratimod combined with one dose of diprospan. 30 untreated IgG4-RD patients with mild symptom will be enrolled in this study, and be treated with one dose of diprospan,then take Iguratimod 25mg, Bid orally. 5 ml of patients' peripheral blood will be collected at baseline, 12 weeks and 24 weeks of follow up. At baseline and each follow-up, the clinical efficacy of treatment will be evaluated by IgG4-RD responder index, serum immunoglobulin, IgG4, immunoglobulin E (IgE), serum cytokines, such as interleukin 1, 6, and tumor necrosis factor, will be measured by ELISA, peripheral blood T cell sub-populations, B cell sub-populations and plasma cells will be measured by flow-cytometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Mikulicz disease, with/without nasosinusitis or lymph node swelling.
- •Without internal organs affected,
- •With slow disease progression.
排除标准
- •Vital organs related:including autoimmune pancreatitis,retroperitoneal fibrosis, sclerosing cholangitis, lung related, kidney affected, IgG4 related castleman's disease and hypophysitis，
- •Combined with other connective disease,
- •With tumors,
- •Pregnancy or to be pregnant,
- •Active infection, including hepatitis B virus, hepatitis C virus, and tuberculosis.
- •Leucocytopenia, impairment of liver and kidney function,
- •Allergy of Iguratimod, or cannot tolerate Iguratimod.
研究组 & 干预措施
Signal arm study
Patients with mild symptom IgG4-RD are enrolled and inject one dosage of diprospan ,then take Iguratimod (T614), 25mg, Bid orally for three months. Firstly, we evaluate IgG4-RD responder index of patients at baseline and follow-up time.We collect the laboratory parameters and blood for lymphocytes subpopulations by flowcytometry.
干预措施: T 614 (Drug)
结局指标
主要结局
The change of IgG4-RD responder index before treatment and after treatment
时间窗: 24 weeks
Evaluate patients baseline and follow-up IgG4-RD responder index(disease activity)
次要结局
- Side effects(24 weeks)
- Changes of serum immunoglobulins subclass IgG4 levels(24 weeks)
- Patients serum cytokines(24 weeks)
- Peripheral blood lymphocytes sub-populations(24 weeks)
研究者
Wen Zhang
professor
Peking Union Medical College Hospital