Etanercept in Kawasaki Disease

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Brief Title

Etanercept in Kawasaki Disease

Official Title

A Randomized, Double Blind, Placebo Controlled Study of the Effects of Etanercept in Children Presenting With Kawasaki Disease

Brief Summary

      The purpose of this study is to determine whether Etanercept (Enbrel) when used in
      conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with
      Kawasaki Disease. Funding Source- FDA/OOPD
    

Detailed Description

      Kawasaki Disease (KD) is a potentially life threatening acute vasculitis in children with a
      predilection for involvement of the coronary arteries. Aspirin and Intravenous gamma globulin
      (IVIG) are principally used for the treatment of the symptoms of Kawasaki Disease. Aspirin
      reduces inflammation and platelet formation, but has no effect in attenuating the development
      of coronary abnormalities. Although IVIG reduces inflammation and the prevalence of coronary
      artery abnormalities, it has a relatively high failure rate of 23-30%, warranting new
      treatment methods for Kawasaki Disease. We propose a placebo controlled double blinded
      randomized study to determine if etanercept 0.8 mg/kg subcutaneously (max 25 mg) given three
      times at weekly intervals starting at initial diagnosis is safe in this patient population
      and if it is a successful adjunct therapy with IVIG in reducing the incidence of persistent
      or recurrent fever.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Determine if Etanercept at the dosing regimen of 0.8 mg/kg (50 mg max) SQ X3 doses given at weekly intervals, when used in conjunction with IVIG and aspirin will reduce the incidence of fever persistence or recrudescence.

Secondary Outcome

 Determine if the safety profile differs between the etanercept treated group and the placebo group.

Condition

Mucocutaneous Lymph Node Syndrome

Intervention

Etanercept

Study Arms / Comparison Groups

 Arm 1 -Etanercept
Description:  Drug - Treatment with Etanercept as adjunct to standard treatment with IVIG and aspirin

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

196

Start Date

March 2009

Completion Date

August 2018

Primary Completion Date

January 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Male Age 2 months to 20 years of age Female Age 2 months to 11 years of age

          -  Provision of Parental Consent

          -  Kawasaki Disease Presentation

        Exclusion Criteria:

          -  Laboratory Criteria: Any laboratory toxicity, at the time of the screening visit or at
             any time during the study that in the opinion of the Investigator would preclude
             participation in the study or:

               1. Platelet count < 100,000/mm3

               2. WBC count < 3,000 cells/mm3

               3. Hemoglobin, hematocrit, or red blood cell count outside 30% of the upper or lower
                  limits of normal for the Lab

          -  Subject is currently enrolled in another investigational device or drug trial(s), or
             subject has received other investigational agent(s) within 28 days of baseline visit.

          -  Female subjects diagnosed with KD 12 years of age and older.

          -  Subjects who have known hypersensitivity to Enbrel or any of its components or who is
             known to have antibodies to etanercept

          -  Prior or concurrent cyclophosphamide therapy

          -  Prior treatment with any TNF alpha antagonist or steroid within 48 hours prior to
             initiation of IVIG

          -  Concurrent sulfasalazine therapy

          -  Active severe infections within 4 weeks before screening visit, or between the
             screening and baseline visits.

          -  SLE, history of multiple sclerosis, transverse myelitis, optic neuritis, or chronic
             seizure disorder

          -  Known HIV-positive status or known history of any other immuno-suppressing disease.

          -  Any mycobacterial disease or high risk factors for tuberculosis, such as family member
             with TB or taking INH

          -  Untreated Lyme disease

          -  Severe comorbidities (diabetes mellitus requiring insulin, CHF of any severity, MI,
             CVA or TIA within 3 months of screening visit, unstable angina pectoris, uncontrolled
             hypertension (sitting systolic BP > 160 or diastolic BP > 100 mm Hg), oxygen-dependent
             severe pulmonary disease, history of cancer within 5 years [other than resected
             cutaneous basal or squamous cell carcinoma or in situ cervical cancer])

          -  Exposure to hepatitis B or hepatitis C or high risk factors such as intravenous drug
             abuse in patient's mother, or history of jaundice (other than neonatal jaundice). SLE,
             history of multiple sclerosis, transverse myelitis, optic neuritis or chronic seizure
             disorder.

          -  Use of a live vaccine (Measles Mumps Rubella or Varicella) 30 days prior to or during
             this study.

          -  Any condition judged by the patient's physician to cause this clinical trial to be
             detrimental to the patient

          -  History of non-compliance with other therapies

          -  Must not have received immunosuppressive agents for at least three months prior to
             enrollment.
      

Gender

All

Ages

2 Months - 20 Years

Accepts Healthy Volunteers

No

Contacts

Michael A Portman, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00841789

Organization ID

SEA-12652

Secondary IDs

FD003526

Responsible Party

Sponsor-Investigator

Study Sponsor

Michael Portman

Collaborators

 Amgen

Study Sponsor

Michael A Portman, MD, Principal Investigator, Seattle Children's Hospital


Verification Date

April 2018