The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial: A Phase III, Randomized Trial of Second Intravenous Immunoglobulin Versus Infliximab for Resistant Kawasaki Disease

Authors

Samantha C. Roberts
Sonia Jain
Adriana H. Tremoulet
Katherine K. Kim
Jane C. Burns
KIDCARE Multicenter Study Group
Vikram Anand
Marsha Anderson
Jocelyn Ang
Emily Ansusinha
Moshe Arditi
Negar Ashouri
Allison Bartlett
Archana Chatterjee
Roberta DeBiasi
Cornelia Dekker
Sylvia Yeh

Journal Title

Contemporary Clinical Trials

First Page

98

Last Page

103

Document Type

Article

Publication Date

April 2019

Department

Pathology, Microbiology and Immunology

Abstract

BACKGROUND: Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease (KD), the most common cause of acquired heart disease in children, 10-20% of patients are IVIG-resistant and require additional therapy. This group has an increased risk of coronary artery aneurysms (CAA) and there has been no adequately powered, randomized clinical trial in a multi-ethnic population to determine the optimal therapy for IVIG-resistant patients. OBJECTIVES: The primary outcome is duration of fever in IVIG-resistant patients randomized to treatment with either infliximab or a second IVIG infusion. Secondary outcomes include comparison of inflammatory markers, duration of hospitalization, and coronary artery outcome. An exploratory aim records parent-reported outcomes including signs, symptoms and treatment experience. METHODS: The KIDCARE trial is a 30-site randomized Phase III comparative effectiveness trial in KD patients with fever >/=36h after the completion of their first IVIG treatment. Eligible patients will be randomized to receive either a second dose of IVIG (2g/kg) or infliximab (10mg/kg). Subjects with persistent or recrudescent fever at 24h following completion of the first study treatment will cross-over to the other treatment arm. Subjects will exit the study after their first outpatient visit (5-18days following last study treatment). The parent-reported outcomes, collected daily during hospitalization and at home, will be compared by study arm. CONCLUSION: This trial will contribute to the management of IVIG-resistant patients by establishing the relative efficacy of a second dose of IVIG compared to infliximab and will provide data regarding the patient/parent experience of these treatments.

Comments

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Recommended Citation

Roberts, S., Jain, S., Tremoulet, A., Kim, K., Burns, J., KIDCARE Multicenter Study Group., Anand, V., Anderson, M., Ang, J., Ansusinha, E., Arditi, M., Ashouri, N., Bartlett, A., Chatterjee, A., DeBiasi, R., Dekker, C., & Yeh, S. (2019). The Kawasaki Disease Comparative Effectiveness (KIDCARE) trial: A Phase III, Randomized Trial of Second Intravenous Immunoglobulin Versus Infliximab for Resistant Kawasaki Disease. Contemporary Clinical Trials, 79, 98-103. https://doi.org/10.1016/j.cct.2019.02.008