Document Detail


Etanercept as adjunctive treatment for acute Kawasaki disease: study design and rationale.
MedLine Citation:
PMID:  21392603     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Kawasaki disease (KD) is a multisystem vasculitis affecting coronary arteries in children. Patients, refractory to standard treatment with intravenous immunoglobulin and aspirin, show higher rates of coronary artery dilation. Early tumor necrosis factor α receptor antagonism in KD may provide effective adjunctive therapy.
STUDY DESIGN: The EATAK trial is a multicenter, double-blind, randomized, and placebo-controlled trial intended to assess the efficacy of etanercept in reducing the intravenous immunoglobulin refractory rate during treatment of acute KD. Each arm will enroll 110 patients who will receive 3 doses of study drug over 2 weeks in conjunction with standard therapy. Coronary artery dilation parameters will serve as secondary end points.
DISCUSSION: The EATAK trial will test a new paradigm for treatment of acute KD involving tumor necrosis factor α antagonism by etanercept.
Authors:
Michael A Portman; Aaron Olson; Brian Soriano; Nagib Dahdah; Richard Williams; Edward Kirkpatrick
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  American heart journal     Volume:  161     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-03-11     Completed Date:  2011-05-26     Revised Date:  2013-03-18    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  494-9     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2011 Mosby, Inc. All rights reserved.
Affiliation:
Seattle Children's Hospital, WA 98101, USA. michael.portman@seattlechildrens.org
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00841789
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MeSH Terms
Descriptor/Qualifier:
Coronary Vessels / pathology
Dilatation, Pathologic
Endpoint Determination
Humans
Immunoglobulin G / administration & dosage,  therapeutic use*
Immunoglobulins, Intravenous / therapeutic use
Immunologic Factors / therapeutic use
Receptors, Tumor Necrosis Factor / administration & dosage,  antagonists & inhibitors*,  therapeutic use
Research Design
Grant Support
ID/Acronym/Agency:
R01-FD-003526/FD/FDA HHS; UL1 RR025014/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Immunoglobulin G; 0/Immunoglobulins, Intravenous; 0/Immunologic Factors; 0/Receptors, Tumor Necrosis Factor; 185243-69-0/TNFR-Fc fusion protein

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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