A 12 month, open label, parallel-cohort study to evaluate the efficacy, safety and tolerability of canakinumab in children with Kawasaki disease

Phase 2

Recruiting

Conditions: Acute vasculitis
10011082
10002363

Registration Number: NL-OMON52448

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Written informed consent, must be obtained by the legal guardian(s)
Female / male patients < 12 years
Active Kawasaki disease defined as:
1. fever >= 38.5°C for 4 days
2. four out of five of the following clinical crtiteria: (i) conjuctival
infection, (ii) oral muscous membrane changes, (e.g. infected pharynx or
strawberry tongue), (iii) erythema of hands or feet, (iv)polymorphous rash, (v)
cervical lymphadenopathy
OR
IVIG-nonresponsiveness, defined as persistent fever 48 hours after IVIG

Exclusion Criteria

a. Fever for 8 days or longer for IVIG-naive patients (cohort 2)
b. Treatment with biologicals (e.g. Anakinra, Etanercept, Infliximab,
Tocilizumab, Adalimumab)
c. Every other study medication given 30 days prior to inclusion
d. Immunosuppressive drugs given within 3 months prior to inclusion
e. Known history of allergy to biologicals
f. Significant abnormalities on ECG, or symptoms compatible with myocaridal
ischemia or infarction
which may jeopardize the participation to this study.
g. Every other decision of the prjnciple investigator regarding safety or
otherwise that will preclude
inclusion.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Determine how many patients will be fever-free after administration of<br /><br>Canakinumab, in which fever-free is defined as a body temperature of <37.5<br /><br>degrees Celsius after 48 hours.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Determine how many patients develop coronary artery aneurysms in week 6-8<br /><br>and at 6 and 12 months after administration of the therapy.<br /><br>2. The location, number of coronary artery aneurysms (CAA) and diameter.<br /><br>3. Follow the development of CAA over time with echocardiography.</p><br>