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A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease

NCT00841789 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2023-05-06

Study results available
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Summary

The purpose of this study is to determine whether Etanercept (Enbrel) when used in conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with Kawasaki Disease. Funding Source- FDA/OOPD

Conditions

  • Mucocutaneous Lymph Node Syndrome
  • Kawasaki Disease

Interventions

DRUG

Etanercept

etanercept 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.

DRUG

Placebo

Placebo 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Michael Portman

    lead OTHER

Principal Investigators

  • Michael A Portman, MD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2018-01-31
Completion
2018-08-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00841789 on ClinicalTrials.gov