Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease

Recruiting at1 trial location

Overseen by Jane C Burns, M.D.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of California, San Diego

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Research Team

Octavio Ramilo, M.D.

Principal Investigator

University of Texas

Adriana H. Tremoulet, M.D.

Principal Investigator

University of California, San Diego

Jane C Burns, M.D.

Principal Investigator

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

All eligible subjects, or legal representative, must provide written informed consent/assent, prior to initiation of any study procedure.

Eligible subjects will be infants and children, 4 weeks to 17 years old, who have had fever for 3 to 15 days (illness day 1 = first day of fever ≥ 38.3° C)

Case definition for complete KD: Fever (≥ 38.3°C) for ≥ 3 days and 4/5 standard clinical criteria (Table 1)

Treatment Details

Interventions

• Infliximab (Monoclonal Antibodies)

Participant Groups

Group I: 1 Experimental Treatment 1 Intervention

Infliximab plus Intravenous immunoglobulin (IVIG)

Group II: 2 Placebo Group 1 Intervention

Placebo plus IVIG

Infliximab is already approved in Canada, Japan for the following indications:

Approved in Canada as Remicade for:

• Ankylosing Spondylitis
• Crohn's Disease
• Ulcerative Colitis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Plaque Psoriasis

Approved in Japan as Remicade for:

• Ankylosing Spondylitis
• Crohn's Disease
• Ulcerative Colitis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Plaque Psoriasis

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Catherine Krawczeski

Nationwide Children's Hospital

Chief Medical Officer

MD

Timothy C. Robinson

Nationwide Children's Hospital

Chief Executive Officer since 2019

BSc in Psychology and Business Administration from Indiana University