CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 196 enrolled
Drug / intervention
Infliximab +1 moredrug
Likely dose
Infliximab 5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00760435
NCT00760435Phase 3Completed
CompareCT.gov

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

University of California, San Diego·interventional·Posted Sep 26, 2008·Updated Nov 24, 2014

In Brief

A Phase 3 clinical trial evaluating Infliximab and Placebo for Kawasaki Disease. Completed, enrolled 196 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKawasaki Disease
CountriesUnited States
CollaboratorsNationwide Children's Hospital

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 26, 2008
Enrollment StartMar 1, 2009
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.8 years ago

Interventions

Infliximabdrug

5 mg/kg IV over 2 hours once

Placebodrug

Placebo (same volume as active drug)