Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease

Efficacy of Primary Treatment With Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease: a Multicenter, Open-Label, Blinded-End Randomized Controlled Study.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000037634

Enrollment

Unknown

Registered

2020-08-29

Start date

2020-10-10

Completion date

Unknown

Last updated

2020-11-02

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

Conditions

Kawasaki disease (mucocutaneous lymph node syndrome)

Interventions

the standard group:IVIG at a single dose of 2 g/kg

the standard group:aspirin 30mg/kg/d

infliximab+IVIG+aspirin group:IVIG at a single dose of 2 g/kg

infliximab+IVIG+aspirin group:aspirin 30mg/kg/d

infliximab+IVIG+aspirin group:intravenous infliximab 5mg/kg*1 (given more than 2 hours)

Eligibility

Sex/Gender

All

Age

1 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Meeting diagnostic criteria for KD released by American Heart Association (AHA) in 2017, including complete KD (also sometimes referred to as typical or classic KD) and incomplete KD ((also sometimes referred to as atypical KD); 2. Diagnosed within 14 days of illness (including the 14th day, considering the first day of illness as the first day of fever); 3. Not treated with IVIG or other treatments for KD yet; 4. Z score of any coronary artery of LMCA, LAD, LCX, the proximal and middle segment of RCA >= 2 calculated based on the height, weight and coronary artery diameter measured by echocardiography; 5. Aged between one month and 14 years.

Exclusion criteria

Exclusion criteria: 1. Receiving steroids or other immunosuppressive agents in the previous 30 days; 2. With a previous history of KD; 3. Afebrile and all the inflammation indicators (including white blood cell count, CRP, and erythrocyte sedimentation) become normal before enrolment; 4. With suspected infectious diseases including tuberculosis, sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, influenza, EBV infection, etc; 5. With serious immune diseases such as immunodeficiency or chromosomal abnormalities; 6. Unable to be followed up for at least 1 year.

Design outcomes

Primary

Measure	Time frame
Percentage of the regression of coronary artery lesion (CAL) at one month of illness;	—

Secondary

Measure	Time frame
Duration of fever (hours) after initiation of initial IVIG infusion;Percentage of the need for additional treatment;Change in serum C-reactive protein (CRP) concentration;	—

Countries

China

Contacts

Public ContactGuoying Huang

Children's Hospital of Fudan University

gyhuang@shmu.edu.cn+86 18017590999

Outcome results

None listed

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