Clinical trial NCT02298062: Infliximab for Kawasaki Disease Patients Resistant to IVIG : a Multicentre, Prospective, Randomised Trial
Official title: Infliximab for Kawasaki Disease Patients Resistant to Intravenous Immunoglobulin : a Multicentre, Prospective, Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kawasaki Disease
Keywords: Kawasaki disease coronary artery lesion, IVIG- resistant, Infliximab
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Medical Center
name: Shanghai 10th People's Hospital
name: Shanghai 8th People's Hospital
name: Shanghai Xuhui Distrct Center Hospital
First posted: 2014-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* (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

Exclusion Criteria:

. 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.

Primary outcomes:
measure: change in concentrations of cytokines
timeFrame: 2 years
Secondary outcomes:
measure: incidence of coronary artery lesions(CAL)
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
state: Shanghai
Study officials:
References: