Infliximab (Remicade) for Patients With Acute Kawasaki Disease
Condition: Kawasaki Disease
MeSH terms: Mucocutaneous Lymph Node Syndrome
Intervention: Infliximab (Remicade); Intravenous immunoglobulin (IVIG)
Intervention description: Remicade was 5 mg/kg IV (single dose); 2nd dose of IVIG (2g/kg)
Intervention MeSH terms: Infliximab; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the safety of infliximab in infants and children with acute Kawasaki
      Disease.
    

Eligibility criteria:

        Inclusion criteria

        To be eligible for the trial, subjects must meet all of the following criteria:

          1. All eligible subjects, or legal representative, must provide written informed
             consent/assent, prior to initiation of any study procedure.

          2. Eligible subjects will be infants and children, under 18 years old, with acute KD who
             remain or become febrile (>/= 38.3˚ C or 101.0˚ F) after the end of the 48 h-period
             after completing their IVIG infusion (2gm/kg).

          3. Patients must have persistent or reoccurrence of fever > 48 hours of observation to be
             eligible for the trial.

          4. Prior to the initial IVIG treatment, patients must have been febrile for >/= 3 days
             and have met 4/5 standard clinical criteria (Table 1) - OR - patients with fever and
             3/5 clinical criteria will be eligible if echocardiogram demonstrates at least one
             coronary artery segment with a Z score of > 2.

          5. Patients must present for their initial diagnosis and IVIG treatment within the first
             14 days after fever onset (Illness Day 14).

          6. Females of childbearing potential and males must be using adequate contraception
             (abstinence, oral contraceptives, intrauterine device, barrier method with spermicide,
             or surgical sterilization) throughout the trial.

          7. All eligible subjects must have a chest radiograph within one week prior to first
             infusion of study drug with no evidence of malignancy, infection or fibrosis.

        Exclusion criteria

        If a subject has any of the following criteria, he or she may not be enrolled in the study:

          1. Have been receiving corticosteroids (ie, via any route) at doses > 1 mg/kg prednisone
             equivalent daily.

          2. Have history of TB or TB exposure.

          3. Have history of histoplasmosis or coccidiomycosis.

          4. Have received anakinra (Kineret®), etanercept (Enbrel®), or adalimumab (Humira®)
             within 1 month prior to first study drug administration.

          5. Have any chronic disease, except asthma, atopic dermatitis or controlled seizure
             disorder.

          6. Have documented history of current active hepatitis B or a history of hepatitis C
             infection.

          7. Have documented history of human immunodeficiency virus (HIV) infection

          8. Have received a transplanted organ (with the exception of a corneal transplant
             performed > 3 months prior to first study drug administration).

          9. Have a known malignancy or history of malignancy within the 5-year period prior to
             first study drug administration (with the exception of squamous or basal cell
             carcinoma of the skin that has been completely excised without evidence of
             recurrence).

         10. Have a history of prior lymphoproliferative disease including lymphoma.

         11. Have multiple sclerosis or other central demyelinating disorder.

         12. Have received any previous treatment with infliximab or other monoclonal antibodies.

         13. Have used any investigational drug within 1 month prior to first study drug
             administration or within 5 half-lives of the investigational agent, whichever is
             longer.

         14. Are participating in another investigative trial, involving investigational agents,
             during participation in this trial.

         15. Have a history of substance abuse (drug or alcohol) within the previous 3 years.

         16. Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or
             within the 6-month period thereafter.

         17. Have a known allergy to murine proteins or other chimeric proteins.

         18. Patients with ischemic congestive heart failure.