Study of efficacy and safety of Canakinumab in patients with Kawasaki disease

Phase 1

• Conditions: Active Kawasaki disease; MedDRA version: 20.0Level: PTClassification code 10023320Term: Kawasaki's diseaseSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-002783-27-NL
• Lead Sponsor: Amsterdam University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-15
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

The presence of a complete clinical diagnosis of Kawasaki Disease.
Two patient categories are identified for patient inclusion: 1. IVIG-resistent patients (having fever at 48 hrs after start of IVIG); and 2. patients who have been diagnosed with Kawasaki disease before day 8 and have not yet been treated with IVIG.
Inclusion of patients aged 0-12 years.
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who were successfully treated with IVIG. Aged 12 years or more, Patietns using immunosuppressive biologicals.
Cardiac signs of mycocardial ischemia or infarction.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy, tolerability and saftey of Canakinumab in Kawasaki Disease .<br>The primary objective of this study is to evaluate the proportion of patients which show resolution of fever?;Secondary Objective: A: Does Canakinumab reduce the incidence of coronary artery lesions in patients?<br>B: Does Canakinumab prevent the need of further treatment with IVIG and/or corticosteroids?;Primary end point(s): The proportion of patients which show resolution of fever;Timepoint(s) of evaluation of this end point: Fever after 48 hrs of Canakinumab

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): proprtion of coronary artery lesions at 2, 6 and 12 months after Canakinumab;Timepoint(s) of evaluation of this end point: Duration of trial