Kawasaki Disease
Conditions
Keywords
Kawasaki disease, Coronary artery aneurysm, mucocutaneous lymph node syndrome, lymph node syndrome, canakinumab, intravenous immunoglobulin naïve (IVIG-naïve), intravenous immunoglobulin refractory (IVIG-refractory), pediatric
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.
Interventions
DRUGCanakinumab
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Days to 10 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: -Active Kawasaki disease defined as: * fever ≥38.5°C for ≥5 days * four out of five of the following criteria: (i) conjunctival injection, (ii) oral mucous membrane changes, (e.g., injected pharynx, or strawberry tongue), (iii) erythema of hands or feet, (iv) polymorphous rash, (v) cervical lymphadenopathy Key
Exclusion criteria
Patients fulfilling any of the following criteria are not eligible for inclusion in this study: * Previous Kawasaki Disease diagnosis, refractory and/or incomplete Kawasaki disease (for IVIG-naïve patients, Cohort 1) * Patients who had fever for longer than a week (for Intravenous Immunoglobulin-naïve patients, Cohort 1), or longer than 14 days (for Intravenous Immunoglobulin-refractory patients, Cohort 2) * History of hypersensitivity to any of the study drugs or to drugs or similar chemical classes or excipients (e.g. citric acid and anhydrous sodium chloride disodium edetate dehydrate polysorbate 80; sodium hydroxide; water for injections) Other protocol-defined inclusion/exclusion may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| resolution of fever | Day 3/4 |
Secondary
| Measure | Time frame |
|---|---|
| proportion of patients developing coronary artery aneurysms | 12 weeks |
| time to resolution of fever | 12 weeks |
| proportion of patients with remittent fever | 12 weeks |
| proportion of patients with C-reactive Protein reduction | 12 weeks |
| Coronary artery aneurysm evolution over time | 12 weeks |
| proportion of patients with coronary artery aneurysm | 12 weeks |
| size of coronary artery aneurysm | 24 weeks |
Outcome results
None listed