Clinical Trial: Infliximab (Remicade) for Patients With Acute Kawasaki Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Infliximab (Remicade) for Patients With Acute Kawasaki Disease Who Fail to Become Afebrile After Intravenous Gamma Globulin Therapy

Brief Summary: This study evaluates the safety of infliximab in infants and children with acute Kawasaki Disease.

Detailed Summary: This study is an exploratory, pilot study to examine tolerance and pharmacokinetics of infliximab in infants and children with acute Kawasaki Disease.
Sponsor: University of California, San Diego

Current Primary Outcome:

  • Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration) [ Time Frame: 2 weeks ]
    The safety of giving infliximab to treat IVIG-resistant Kawasaki disease was measured by recording the number of adverse events that occurred in each group. An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of either IVIG or infliximab, regardless of whether it was considered related to IVIG or infliximab, that occured during the course of this study.In particular we evaluated for AEs related to side effects from infliximab or IVIG.
  • Area Under the Curve of Infliximab Concentration Before Infliximab Infusion and Then 2 and 24 Hours, 1 Week (5 to 9 Days), 2 Weeks (12 to 16 Days), and 4 Weeks (26 to 30 Days) After Infliximab Infusion) [ Time Frame: before infliximab infusion and then 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion. ]
    The area under the curve (AUC) from time 0 to the last measurable concentration (AUC0-last) was estimated using the trapezoidal rule up to the last measurable concentration.Samples were collected before infliximab infusion and then at 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion. Subjects with detectable infliximab concentrations at week 4 had another sample drawn at week 10 (68 to 72 days).


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, San Diego

Dates:
Date Received: December 30, 2005
Date Started: April 2004
Date Completion:
Last Updated: June 11, 2010
Last Verified: November 2009