Clinical Trial: Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
Brief Summary: The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or refractory patients diagnosed with active Kawasaki disease, administration of canakinumab controls fever and acute phase reactants.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: resolution of fever [ Time Frame: Day 3/4 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- proportion of patients with C-reactive Protein reduction [ Time Frame: 12 weeks ]
- proportion of patients developing coronary artery aneurysms [ Time Frame: 12 weeks ]
- time to resolution of fever [ Time Frame: 12 weeks ]
- proportion of patients with remittent fever [ Time Frame: 12 weeks ]
- size of coronary artery aneurysm [ Time Frame: 24 weeks ]
- Coronary artery aneurysm evolution over time [ Time Frame: 12 weeks ]
- proportion of patients with coronary artery aneurysm [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: October 24, 2016
Date Started: November 15, 2016
Date Completion: November 30, 2017
Last Updated: February 15, 2017
Last Verified: February 2017
