Safety and Efficiency Study of Low-dose IL-2 Treatment in Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants Who Were SLE Responders (SRI)
研究概览
简要总结
This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic lupus erythematosus.
详细描述
Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs. While available therapies, such as corticosteroids and immunosuppressive agents have improved the outcome of patients, there remains a significant unmet need for safe and more effective treatments. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). We hypothesized that low-dose IL-2 could be a novel therapy in active SLE patients.
This is a single center, uncontrolled, open-label study to assess the efficacy/safety of low dose IL-2 plus standard therapy in active SLE.
Methods: Each SLE patients (n=40) with Scores>=8 on the Safety of Estrogens in Lupus Erythematosus National Assessment (AELENA) version of the SLE Disease Activity Index (SLEDAI) that was refractory or relaps to glucocorticoid therapy received low-dose IL-2 (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 cycles according to the situation of the disease. The end points were safety and clinical and immunologic response.
Expected Results: This trail will define low-dose IL-2 plus standard therapy is efficacy and safety with active lupus patients, which could be relevant to the amelioration the abnormity of T help cells in SLE patients.
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 65 Years（Adult, Older 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
Number of Participants Who Were SLE Responders (SRI)
时间窗: week 2，week 4，week 6，week 8，week 10
SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.
次要结局
- The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients(week 0 and week 10)
- Immunological Responses(week 0 and week 10)
- SELENA SLEDAI Score(week 0, week 10)
- Number of Relapses(24 weeks)
- Safety Assessment(up to Day 180)