Clinical Trial: Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: University of California, San Diego

Current Primary Outcome: The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion [ Time Frame: 10 weeks ]

Original Primary Outcome: The larger of the z scores (normalized for body surface area) of the internal diameter of the right and left anterior descending coronary arteries at follow up [ Time Frame: 2 weeks ]

Current Secondary Outcome:

  • Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks) [ Time Frame: up to 6 weeks ]
  • Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm. [ Time Frame: 24 hours ]
  • Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm [ Time Frame: 2 weeks ]
    left anterior descending coronary artery Z-score; a Z score is the coronary artery adjusted for body surface area


Original Secondary Outcome:

  • Number of days of fever following therapy [ Time Frame: 2 weeks ]
  • z hemoglobin adjusted for age [ Time Frame: 2 weeks ]
  • Markers of inflammation including C-reactive protein, platelet count, white blood cell count, absolute neutrophil count, and percent bands [ Time Frame: 2 weeks ]
  • The area under the curve for temperature [ Time Frame: 2 weeks ]


Information By: University of California, San Diego

Dates:
Date Received: September 25, 2008
Date Started: March 2009
Date Completion:
Last Updated: November 12, 2014
Last Verified: November 2014