The Incidence of Infection in Treatment of Low-dose IL-2 Combined With Corticosteroid and Immunosuppressor in SLE Patients- a Multi-center Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The incidence of infection of two groups
研究概览
简要总结
IL-2 is a pleiotropic cytokine which can regulate or stimulate the differentiation and function of CD4+, CD8+ and NK cells. An opened-labelled trial and a retrospective study have indicated the incidence of infection is lower in the treatment of low-dose IL-2 combined with corticosteroid and immunosuppressor. We are going to conduct a multi-center prospective observational study to verify the above results.
详细描述
We are going to conduct a multi-center prospective observational study, and plan to enroll 500 SLE patients. Low-dose IL-2 is defined as 100IU IL-2 injected subcutaneously every other day for two weeks, followed by two-week break as one treatment cycle, and at least three weeks.There will be 250 patients in low-dose IL-2 group which treat with IL-2 combined with steroid and immunosuppressor. Non-IL-2 group is only treat with steroid and immunosuppressor. These patients are followed by every one month until get infected, otherwise, patients will be followed for two years. We focus on the type, positive microorganisms, grade and treatment of infection. Then, we will compare the differences of above parameters between these two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SLE patients diagnosed by the ACR Criteria of 1987;
- •Treated with low-dose IL-2, corticosteroid and immunosuppressor for SLE.
- •Consent to participate in this study.
- •Regular follow-up for at least 2 years.
排除标准
- •Other autoimmune disease;
- •Without treatment of low-dose IL-2, corticosteroid and immunosuppressor for SLE.
- •Mental disorder without regular or specific treatment.
研究组 & 干预措施
Low-dose IL-2 group
Patients in this group were treated with low-dose IL-2 combined with corticosteroid and immunosuppressor, and low-dose IL-2 is defined as 100IU subcutaneously every other day for two weeks, followed by two-week break, as one treatment cycle, and at least three cycles.
干预措施: IL-2 (Drug)
结局指标
主要结局
The incidence of infection of two groups
时间窗: 2 years
Infection is confirmed by art least one infectious specialist or rheumatologist, by means of clinical symptoms, positive microorganisms culture, response to antibiotic therapy.
次要结局
未报告次要终点