Effecacy of infliximab on IVIG-unresponsive Kawasaki disease: a single center prospective randamized controlled study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900027954

Enrollment

Unknown

Registered

2019-12-07

Start date

2020-01-01

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kawasaki disease

Interventions

IVIG group:Treatment with a second dose of IVIG

infliximab group:Treatment with infliximab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A. children diagnosed as Kawasaki disease according to the AHA statement published in 2017; B. children with persistent fever (axillary temperature >= 38 degree C for no less than 4 hours) after 36 hours since the initial IVIG therapy (2g/kg, or 1g/kg x 2days) within 4 to 10 days from onset of Kawasaki disease; C. age and gender unlimited; D. axillary temperature >= 37.5 degree C at enrollment; E. the use of infliximab within 10 days from onset.

Exclusion criteria

Exclusion criteria: A. contraindications for the use of infliximab; B. not IVIG as the initial therapy of Kawasaki disease; C. use of systemic steroids within 4 weeks; D. history of treatment with infliximab or other biological agents; E. live vaccination within 1 month.

Design outcomes

Primary

Measure	Time frame
febrile duration after treatment;defervescent rate within 48h after treatment;reintervention rate;incidence of coronary artery lesions;	—

Secondary

Measure	Time frame
white blood cell;C-reactive protein;TNF-a;interleukin-6;interleukin-8;interleukin-10;	—

Countries

China

Contacts

Public ContactYanfei Wang

Guangzhou Women and Children's Medical Center

wangyanfei@gwcmc.org+86 18100202078

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026