Infliximab (Remicade) for Patients With Acute Kawasaki Disease

Inclusion criteria

To be eligible for the trial, subjects must meet all of the following criteria:

• All eligible subjects, or legal representative, must provide written informed consent/assent, prior to initiation of any study procedure.
• Eligible subjects will be infants and children, under 18 years old, with acute KD who remain or become febrile (>/= 38.3˚ C or 101.0˚ F) after the end of the 48 h-period after completing their IVIG infusion (2gm/kg).
• Patients must have persistent or reoccurrence of fever > 48 hours of observation to be eligible for the trial.
• Prior to the initial IVIG treatment, patients must have been febrile for >/= 3 days and have met 4/5 standard clinical criteria (Table 1) - OR - patients with fever and 3/5 clinical criteria will be eligible if echocardiogram demonstrates at least one coronary artery segment with a Z score of > 2.
• Patients must present for their initial diagnosis and IVIG treatment within the first 14 days after fever onset (Illness Day 14).
• Females of childbearing potential and males must be using adequate contraception (abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the trial.
• All eligible subjects must have a chest radiograph within one week prior to first infusion of study drug with no evidence of malignancy, infection or fibrosis.

Exclusion criteria

If a subject has any of the following criteria, he or she may not be enrolled in the study:

• Have been receiving corticosteroids (ie, via any route) at doses > 1 mg/kg prednisone equivalent daily.
• Have history of TB or TB exposure.
• Have history of histoplasmosis or coccidiomycosis.
• Have received anakinra (Kineret®), etanercept (Enbrel®), or adalimumab (Humira®) within 1 month prior to first study drug administration.
• Have any chronic disease, except asthma, atopic dermatitis or controlled seizure disorder.
• Have documented history of current active hepatitis B or a history of hepatitis C infection.
• Have documented history of human immunodeficiency virus (HIV) infection
• Have received a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to first study drug administration).
• 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).
• Have a history of prior lymphoproliferative disease including lymphoma.
• Have multiple sclerosis or other central demyelinating disorder.
• Have received any previous treatment with infliximab or other monoclonal antibodies.
• 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.
• Are participating in another investigative trial, involving investigational agents, during participation in this trial.
• Have a history of substance abuse (drug or alcohol) within the previous 3 years.
• Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
• Have a known allergy to murine proteins or other chimeric proteins.
• Patients with ischemic congestive heart failure.