Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease

Inclusion Criteria: * Patients diagnosed with Kawasaki disease (incipient cases only) with 5 or more of the 6 major symptoms of Kawasaki disease. * Patients refractory to initial IVIG therapy (a single administration at 2 g per kg body weight). * Patients with a fever of 37.5ºC or higher axillary temperature at the time of enrollment. * Patients to whom the study drug can be administered by day 8 of disease. Exclusion Criteria: * Patients who have received vaccination with Bacille Calmette-Guérin (BCG) vaccine within 6 months before the enrollment. * Patients with a complication, or a history within 6 months before the enrollment of, serious infections requiring hospitalization. * Patients with a complication, or a history within 6 months before the enrollment of, opportunistic infections. * Patients complicated with active tuberculosis, active hepatitis B or C, or patients confirmed to be hepatitis B virus carriers or a history of hepatitis B. * Patients confirmed to have HIV infection, or patients with a family history of HIV infection. * Patients who have a history of receiving treatment with infliximab or other biological products. * Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving consent.