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Monoclonal Antibodies

1 for Kawasaki Disease

Phase 3
Waitlist Available
Led By Jane C Burns, M.D.
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Study Summary

The purpose of this study is to determine whether the addition of infliximab to standard primary therapy of intravenous immunoglobulin (IVIG) and high dose aspirin will reduce resistance to therapy in acute Kawasaki disease (KD).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion
Secondary outcome measures
Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm
Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm.
Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks)

Side effects data

From 2020 Phase 4 trial • 42 Patients • NCT03006393
52%
Laceration
38%
Headache
24%
Bruises
19%
Sore throat
14%
Muscle tension
10%
Heartburn
10%
Fatigue
10%
Change in urination
10%
Nausea
10%
Dizziness
10%
Itchiness
5%
Pain in joints
5%
Menstruation
5%
Stomach ache
5%
Syncope
5%
Migraine
5%
Chest pain
5%
Swelling
5%
Bloody stool
5%
Pain in leg
5%
Allergies
5%
Change in blood pressure
5%
Vertigo
5%
Change in appetite
5%
Numbness
5%
Motor vehicle accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Infliximab
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Infliximab plus Intravenous immunoglobulin (IVIG)
Group II: 2Placebo Group1 Intervention
Placebo plus IVIG
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infliximab
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,130 Previous Clinical Trials
1,552,663 Total Patients Enrolled
Nationwide Children's HospitalOTHER
341 Previous Clinical Trials
5,220,303 Total Patients Enrolled
Adriana H. Tremoulet, M.D.Study DirectorUniversity of California, San Diego

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The Journal of PediatricsJournal
Infliximab Treatment of Intravenous Immunoglobulin–resistant Kawasaki Disease
Burns, Jane C., Brookie M. Best, Asuncion Mejias, Lynn Mahony, David E. Fixler, Hasan S. Jafri, Marian E. Melish, et al.. 2008. “Infliximab Treatment of Intravenous Immunoglobulin–resistant Kawasaki Disease”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2008.06.011.
clinicaltrials.govStudy
Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease
Jane C. Burns 2009. "Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00760435.
~12 spots leftby May 2025
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