Infliximab (Remicade) for Patients With Acute Kawasaki Disease

Exclusion Criteria

• •If a subject has any of the following criteria, he or she may not be enrolled in the study:
• •1. Have been receiving corticosteroids (ie, via any route) at doses \> 1 mg/kg prednisone equivalent daily.
• •2. Have history of TB or TB exposure.
• •3. Have history of histoplasmosis or coccidiomycosis.
• •4. Have received anakinra (Kineret®), etanercept (Enbrel®), or adalimumab (Humira®) within 1 month prior to first study drug administration.
• •5. Have any chronic disease, except asthma, atopic dermatitis or controlled seizure disorder.
• •6. Have documented history of current active hepatitis B or a history of hepatitis C infection.
• •7. Have documented history of human immunodeficiency virus (HIV) infection
• •8. Have received a transplanted organ (with the exception of a corneal transplant performed \> 3 months prior to first study drug administration).
• •9. Have a known malignancy or history of malignancy within the 5-year period prior to first study drug administration (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence).
• •10. Have a history of prior lymphoproliferative disease including lymphoma.
• •11. Have multiple sclerosis or other central demyelinating disorder.
• •12. Have received any previous treatment with infliximab or other monoclonal antibodies.
• •13. Have used any investigational drug within 1 month prior to first study drug administration or within 5 half-lives of the investigational agent, whichever is longer.
• •14. Are participating in another investigative trial, involving investigational agents, during participation in this trial.
• •15. Have a history of substance abuse (drug or alcohol) within the previous 3 years.
• •16. Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
• •17. Have a known allergy to murine proteins or other chimeric proteins.
• •18. Patients with ischemic congestive heart failure.