NCT00760435

Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease

Infliximab (Remicade®) Plus Intravenous Immunoglobulin (IVIG) for the Primary Treatment of Patients With Acute Kawasaki Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 4 Weeks – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the addition of infliximab to standard primary therapy of intravenous immunoglobulin (IVIG) and high dose aspirin will reduce resistance to therapy in acute Kawasaki disease (KD).

Detailed description

KD, an orphan disease of low prevalence in U.S. children, causes significant long term cardiac sequelae in a subset of patients. KD patients that are resistant to therapy are more likely to develop coronary artery abnormalities. This phase III placebo-controlled, multicenter, randomized clinical trial of infliximab plus standard therapy vs. placebo plus standard therapy in acute KD will determine if the addition of infliximab to primary therapy can reduce the percentage of children resistant to therapy.

Conditions

• Kawasaki Disease

Interventions

Type	Name	Description
DRUG	Infliximab	5 mg/kg IV over 2 hours once
DRUG	Placebo	Placebo (same volume as active drug)

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2008-09-26
• Last updated: 2014-11-24
• Results posted: 2014-11-13

Locations

2 sites across 1 country: United States