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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: Shanghai 10th People's Hospital; Shanghai 8th People's Hospital; Shanghai Children's Medical Center; Shanghai Xuhui Distrct Center Hospital
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Infliximab; Rho(D) Immune Globulin

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.