Brief Title
Infliximab (Remicade) for Patients With Acute Kawasaki Disease
Official Title
Infliximab (Remicade) for Patients With Acute Kawasaki Disease Who Fail to Become Afebrile After Intravenous Gamma Globulin Therapy
Brief Summary
This study evaluates the safety of infliximab in infants and children with acute Kawasaki
Disease.
Detailed Description
This study is an exploratory, pilot study to examine tolerance and pharmacokinetics of
infliximab in infants and children with acute Kawasaki Disease.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)
Condition
Kawasaki Disease
Intervention
Infliximab (Remicade)
Study Arms / Comparison Groups
Second Dose of IVIG (2g/kg)
Description: Subjects who did not respond to the first dose of IVIG received a 2nd dose of IVIG in this arm (2g/kg)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
24
Start Date
April 2004
Completion Date
October 2006
Primary Completion Date
October 2006
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.
Gender
All
Ages
N/A - 18 Years
Accepts Healthy Volunteers
No
Contacts
Jane C Burns, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00271570
Organization ID
041374
Secondary IDs
2004-0548
Study Sponsor
University of California, San Diego
Collaborators
Centocor, Inc.
Study Sponsor
Jane C Burns, M.D., Principal Investigator, UCSD/CHHC
Verification Date
November 2009