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

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Fudan University

Status and phase

Withdrawn
Phase 3

Conditions

Kawasaki Disease

Treatments

Drug: Aspirin
Drug: IVIG
Drug: Infliximab

Study type

Interventional

Funder types

Other

Identifiers

NCT04535518
KD-4-01

Details and patient eligibility

About

This study evaluates the efficacy of the addition of infliximab to conventional initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in early regression of coronary artery lesion in patients with Kawasaki disease (KD).

Full description

This is a multicenter, open-label, blind-end, randomized controlled trial at 5 hospitals in Shanghai, China. The KD children diagnosed within 14 days of onset according to the diagnostic criteria for KD released by American Heart Association (AHA) in 2017 will be considered for participants in the trial. The patients meeting eligibility criteria will be randomly assigned in a 1:1 ratio to the control group (receiving 2 g/kg*1 IVIG and 30 mg/kg/d aspirin) or intervention group (receiving 2 g/kg*1 IVIG, 30 mg/kg/d aspirin and additional 5 mg/kg*1 infliximab) based on the randomly block design (block sizes 4). Baseline characteristics of each participant will be collected, including sex, age of onset, height, body weight, subtype of KD, fever days before initial IVIG, other clinical manifestations, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at least 7 timepoints: at admission, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months after onset of KD to assess the coronary artery lesions.

Sex

All

Ages

1 month to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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);
  • Diagnosed within 14 days of illness (including the 14th day, considering the first day of illness as the first day of fever);
  • Not treated with IVIG or other treatments for KD yet;
  • 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;
  • Aged between one month and 14 years.

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

the standard group
Active Comparator group
Description:
IVIG 2 g/kg once, given within 12 to 24 hours; Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 72 hours and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
Treatment:
Drug: IVIG
Drug: Aspirin
the standard + infliximab group
Experimental group
Description:
IVIG 2 g/kg once, given within 12 to 24 hours; Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 72 hours and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness. Intravenous infliximab at single dose of 5 mg/kg, given more than 2 hours.
Treatment:
Drug: Infliximab
Drug: IVIG
Drug: Aspirin

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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