Infliximab for Kawasaki Disease Patients Resistant to IVIG : a Multicentre, Prospective, Randomised Trial
Condition: Kawasaki Disease
MeSH terms: Mucocutaneous Lymph Node Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Infliximab; IVIG
Intervention type(s): Drug; Drug
Intervention description(s): The treatment-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 primary outcome measure is change in absolute cell counts, concentrations of C-reactive protein, alanine transaminase,IL-1,IL-6,TNF-a,STNFR-I,STNFR-2; number of fever days (24 h period with a temperature of at least 38•0°C) from enrolment; duration and cost of hospital stay.The secondary 0utcome Measure is the incidence of coronary artery abnormalities; The treatment-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 primary outcome measure is change in absolute cell counts, concentrations of C-reactive protein, alanine transaminase,IL-1,IL-6,TNF-a,STNFR-I,STNFR-2; number of fever days (24 h period with a temperature of at least 38•0°C) from enrolment; duration and cost of hospital stay.The secondary 0utcome Measure is the incidence of coronary artery abnormalities
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kawasaki disease coronary artery lesion, IVIG- resistant, Infliximab