Potential Effect of Anti-infection by Low-dose IL-2 in Treatment of SLE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Immunological Responses
研究概览
简要总结
The objective of this clinical study is to evaluate the potential effect of anti-infection of low-does IL-2 in patients with SLE.
详细描述
Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs.Many feel that glucocorticoid and immunosuppressor are the standard therapy for patients with SLE. While it can improve the risk of infection among SLE patients. A novel therapy to treat SLE with low-does IL-2 has been identified recently. IL-2 also used to against some virus infect. So we hypothesized that low-dose IL-2 could reduce risk of infection in SLE patients.
Methods: A total of SLE patients (n=30) were divided into two groups randomly. One received standard therapy, while another one administrate with low-does IL-2 plus standard therapy.Each patient will be treated with low-dose IL-2. The end points are clinical and immunologic response.
Expected Results: This trail wlii provide both clinical and basic profe that low-dose IL-2 plus standard therapy have lower infection risk in SLE patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the American College of Rheumatology criteria for the diagnosis of SLE.
- •Under standard treatment (≥ 2 months) at the time of inclusion
- •Background treatment failed to control flares or to permit prednisone tapering
- •With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria>0.5g/day), neuropsychiatric SLE.
- •Positive for at least one of the following laboratory tests: ANA>1:160, anti-dsDNA, immunoglobulin>20g/L, decreased C3 or C4, leukopenia<3×10^9/L, thrombocytopenia<100×10^9/L;
- •SLE disease activity index(SLEDAI) ≥
- •Negative HIV test.
- •Negative for hepatitis B and C virus.
- •Written informed consent form.
排除标准
- •Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases> 3N) )
- •Serious infection such as bacteremia, sepsis;
- •Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
- •High-dose steroid pulse therapy (>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months.
- •History of administration of rituximab or other biologics;
- •Purified protein derivative (tuberculin) >10mm
- •Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
- •Inability to comply with IL-2 treatment regimen.
研究组 & 干预措施
Interleukin-2
Interleukin-2 to treat activated SLE.
干预措施: Interleukin-2 (Drug)
结局指标
主要结局
Immunological Responses
时间窗: week 0 and week 10
The increased intracellular factors which could reflect the organic immunity
次要结局
- Virus titers(week 0 and week 10)
研究者
Zhanguo Li
Professor and chief of department of rheumatology and immunology
Peking University People's Hospital