Infliximab (Remicade) for Patients With Acute Kawasaki Disease

Phase 1

Completed

• Conditions: Kawasaki Disease
• Interventions: Biological: Intravenous immunoglobulin (IVIG); Drug: Infliximab (Remicade)

• Registration Number: NCT00271570
• Lead Sponsor: University of California, San Diego

Brief Summary

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

Detailed Description

This study is an exploratory, pilot study to examine tolerance and pharmacokinetics of infliximab in infants and children with acute Kawasaki Disease.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-12-30
• Study First Submitted QC: 2005-12-30
• Study First Posted: 2006-01-02
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Results First Submitted: 2009-05-01
• Status Verified: 2009-11
• Results First Submitted QC: 2009-11-23
• Results First Posted: 2009-12-29
• Last Update Submitted: 2010-06-11
• Last Update Posted: 2010-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Second Dose of IVIG (2g/kg)	Intravenous immunoglobulin (IVIG)	Subjects who did not respond to the first dose of IVIG received a 2nd dose of IVIG in this arm (2g/kg)
Infliximab (5mg/kg)	Infliximab (Remicade)	Remicade (5mg/kg) single dose

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)	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)	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).

Trial Locations

Locations (1)

Ucsd/Chhc; 🇺🇸 San Diego, California, United States