Infliximab for Kawasaki Disease Patients Resistant to IVIG : a Multicentre, Prospective, Randomised Trial

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Brief Title

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

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

change in concentrations of cytokines

Secondary Outcome

 incidence of coronary artery lesions(CAL)

Condition

Kawasaki Disease

Intervention

Infliximab

Study Arms / Comparison Groups

 Infliximab
Description:  For one group of patients with resistance to intravenous immunoglobulin in Kawasaki disease , we will give them infliximab (5mg/kg) once.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

40

Start Date

January 2013

Completion Date

September 2015

Primary Completion Date

July 2015

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.

Gender

All

Ages

2 Months - 12 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT02298062

Organization ID

2014-LF

Responsible Party

Principal Investigator

Study Sponsor

Fudan University

Collaborators

 Shanghai Children's Medical Center

Study Sponsor

, ,

Verification Date

December 2014