The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in steroid dose and immunosuppressor dose at 1 year compared to control group
研究概览
简要总结
The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with rheumatic diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis).
详细描述
The investigators designed a single center, open-label, prospective study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines.
Methods: Patients were divided into two groups. One received standard therapy, while another one administrate with low-does IL-2 plus standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age <18 years old
- •meet the diagnostic criteria of disease classification
- •HIV negative;Negative for Hepatitis B Virus and Hepatitis C Virus.
排除标准
- •heart failure (cardiac function ≥ grade III NYHA)
- •liver insufficiency (upper limit of normal range of transaminase > 2 times)
- •renal insufficiency (creatinine clearance ≤30ml/min)
- •acute or severe infections such as bacteremia and sepsis
- •malignant tumor
- •high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month;Rituximab, infliximab or other biological agents were used
- •mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information
- •Inability to comply with IL-2 treatment regimen.
研究组 & 干预措施
Recombinant Human Interleukin-2
Induced remission period,recombinant human IL-2(500,000 unit per square meter) infusions five days;Maintenance treatment period,recombinant human IL-2 infusions five days then once every two weeks for 6 months.
干预措施: IL-2 (Drug)
结局指标
主要结局
Change in steroid dose and immunosuppressor dose at 1 year compared to control group
时间窗: 1 year
The average daily doses of steroid and immunosuppressor per square meter was recorded
次要结局
- The Immunologic Impact of IL-2 Treatment(1 month,3 month,6 month,1 year)
- Immunological Responses(1 month,3 month,6 month,1 year)
- Change from baseline in SELENA SLEDAI Score(1 month,3 month,6 month,1 year)
- Change from baseline in EULAR SS disease activity index(1 month,3 month,6 month,1 year)
- Incidence of adverse drug reactions(up to 1 year)