Infliximab for Kawasaki Disease Patients Resistant to IVIG : a Multicentre, Prospective, Randomised Trial
Information source: Fudan University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kawasaki Disease
Intervention: Infliximab (Drug); IVIG (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Fudan University Overall contact:
Fang liu, Phone: (86)2164931110, Email: liufang@fudan.edu.cn
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.
Clinical Details
Official title: Infliximab for Kawasaki Disease Patients Resistant to Intravenous Immunoglobulin : a Multicentre, Prospective, Randomised Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: change in concentrations of cytokines
Secondary outcome: incidence of coronary artery lesions(CAL)
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
Minimum age: 2 Months.
Maximum age: 12 Years.
Gender(s): Both.
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.
Locations and Contacts
Fang liu, Phone: (86)2164931110, Email: liufang@fudan.edu.cn
Children Hospital of Fudan University, Shanghai, Shanghai 201102, China; Recruiting
Additional Information
Starting date: January 2013
Last updated: November 19, 2014
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