A Phase 2 interventional study of Canakinumab in Kawasaki Disease, sponsored by Novartis Pharmaceuticals. Withdrawn. Open to participants aged 28 Days to 10 Years. Per ClinicalTrials.gov, last updated 2017-02-17.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
64 studies on the registry are indexed under Mucocutaneous Lymph Node Syndrome; 18 are open to participants now.
Browse Mucocutaneous Lymph Node Syndrome studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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Key Inclusion Criteria:
-Active Kawasaki disease defined as:
Key Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
Other protocol-defined inclusion/exclusion may apply.
Drug: Canakinumab
Also known as: ACZ885
resolution of fever
Time frame: Day 3/4
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Mucocutaneous Lymph Node Syndrome→
Novartis Pharmaceuticals