A Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of the safety (type and number of adverse events and serious adverse events) of low-doseIL-2 in patients with SLE
研究概览
简要总结
Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by the investigator's group, the investigators found that the Low-dose IL-2 was effective and well tolerated in active SLE, and the effect was associated with selective modulation of CD4+ T cell subsets.
This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE.
The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).
详细描述
Each SLE patients (n=60) with Scores>=8 on SLEDAI received low-dose IL-2 or placebo (active group: placebo group =1:1, 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 cycles. The end points were safety and clinical and immunologic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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.
- •Negative urine pregnancy test.
- •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
hrIL-2 active
Intervention：Add hrIL-2 according to the protocol to original treatment. HrIL-2 active: 1 million U doses of human recombinant interleukin-2 s.c. injection
干预措施: hrIL-2 active (Drug)
hrIL-2 placebo
1 million U doses of placebo s.c. injection
干预措施: hrIL-2 placebo (Drug)
结局指标
主要结局
Evaluation of the safety (type and number of adverse events and serious adverse events) of low-doseIL-2 in patients with SLE
时间窗: 24 weeks
Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.
Number of Participants Who Were SLE Responders (SRI)
时间窗: week 24
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
未报告次要终点
研究者
Zhanguo Li
Dept. Rheumatology and Immunology
Peking University People's Hospital