NCT00841789

A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease

A Randomized, Double Blind, Placebo Controlled Study of the Effects of Etanercept in Children Presenting With Kawasaki Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Michael Portman · Academic / Other
• Sex: All
• Age: 2 Months – 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Etanercept (Enbrel) when used in conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with Kawasaki Disease. Funding Source- FDA/OOPD

Detailed description

Kawasaki Disease (KD) is a potentially life threatening acute vasculitis in children with a predilection for involvement of the coronary arteries. Aspirin and Intravenous gamma globulin (IVIG) are principally used for the treatment of the symptoms of Kawasaki Disease. Aspirin reduces inflammation and platelet formation, but has no effect in attenuating the development of coronary abnormalities. Although IVIG reduces inflammation and the prevalence of coronary artery abnormalities, it has a relatively high failure rate of 23-30%, warranting new treatment methods for Kawasaki Disease. We propose a placebo controlled double blinded randomized study to determine if etanercept 0.8 mg/kg subcutaneously (max 25 mg) given three times at weekly intervals starting at initial diagnosis is safe in this patient population and if it is a successful adjunct therapy with IVIG in reducing the incidence of persistent or recurrent fever.

Conditions

• Mucocutaneous Lymph Node Syndrome
• Kawasaki Disease

Interventions

Type	Name	Description
DRUG	Etanercept	etanercept 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.
DRUG	Placebo	Placebo 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.

Timeline

• Start date: 2009-03-01
• Primary completion: 2018-01-01
• Completion: 2018-08-30
• First posted: 2009-02-11
• Last updated: 2023-05-06
• Results posted: 2023-05-06

Locations

8 sites across 2 countries: United States, Canada