Infliximab (Remicade) for Patients With Acute Kawasaki Disease

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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