Infliximab for Kawasaki Disease Patients Resistant to Intravenous Immunoglobulin : a Multicentre, Prospective, Randomised Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in concentrations of cytokines
研究概览
简要总结
The objective of this study is to investigate the effect of infliximab to the children who don't respond to the first dose of intravenous immunoglobulin (IVIG) (2g/kg) in Kawasaki disease.
详细描述
Kawasaki disease(KD), the most common cause of acquired heart disease in developed countries, is a self-limited vasculitis that is treated with high doses of intravenous immunoglobulin. Resistance to intravenous immunoglobulin in Kawasaki disease which is defined as a temperature of 38.0°C or higher at 36 hours to 7 days after completion of the infusion of intravenous immunoglobulin increases the risk of coronary artery lesions. We will conduct a multicenter, randomized, prospective trial to determine whether the use of infliximab to the children who don't respond to the first dose of IVIG(2g/kg) reduces the risk of coronary artery diseases. The IVIG-resistant children will be randomly assigned to either the infliximab or IVIG group in a 1:1 ratio and receive either infliximab (5 mg/kg at 1 mg/mL intravenously over 2 h) or IVIG (2g/kg). The level of leukocyte (WBC)counts, C-reactive protein, alanine transaminase,interleukin- 1( IL-1), interleukin- 6(IL-6), tumor necrosis factor-a(TNF-a), soluble tumor necrosis factor receptor-1(STNFR-I), soluble tumor necrosis factor receptor-2(STNFR-2), the fever days,and the cost of hospital stay will be analyzed between these two groups.The final outcome is the incidence of coronary artery lesions.
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
- None
入排标准
- 年龄范围
- 2 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002.(2) Resistance to intravenous immunoglobulin in Kawasaki disease is defined as a temperature of 38.0°C or higher at 36 hours to 7 days after completion of the routine primary treatment .(3) the patients aged from 2 months to 12 years old. (4) All included patients required to sign an informed consent form
排除标准
- •. Exclusion criteria: (1) The patients with severe infections; (2) The patients with a history of tuberculosis or recent close contact with tuberculosis; (3) The patient vaccinated with live vaccine in 6 months; (4)The patients with the application of hormone or other immunosuppressive agents; (5) The patients didn"t want to signed informed consent.
研究组 & 干预措施
Infliximab
For one group of patients with resistance to intravenous immunoglobulin in Kawasaki disease , we will give them infliximab (5mg/kg) once.
干预措施: Infliximab (Drug)
IVIG
For the other group of patients with resistance to intravenous immunoglobulin in Kawasaki disease , we will give them IVIG (2g/kg) once.
干预措施: IVIG (Drug)
结局指标
主要结局
change in concentrations of cytokines
时间窗: 2 years
we will obtain laboratory data including concentrations of C-reactive protein, alanine transaminase,IL-1,IL-6,TNF-a,STNFR-I,STNFR-2 at baseline, 72 h after completion of the intravenous immunoglobulin infusion, and at week 2 and week 4 after randomisation.
次要结局
- incidence of coronary artery lesions(CAL)(2 years)