Patient description: A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.

Clinical trial eligibility criteria: eligible ages (years): 0.0-18.0,  Kawasaki Disease To be eligible for the trial, subjects must meet all of the following 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 (Table 1) patients with fever and 3/5 clinical 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  If a subject has any of the following 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)