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Etanercept in Kawasaki Disease

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Michael Portman, Seattle Children's Hospital Identifier:
First received: February 10, 2009
Last updated: May 1, 2017
Last verified: May 2017
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

Condition Intervention Phase
Mucocutaneous Lymph Node Syndrome
Kawasaki Disease
Drug: Etanercept
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled Study of the Effects of Etanercept in Children Presenting With Kawasaki Disease

Resource links provided by NLM:

Further study details as provided by Michael Portman, Seattle Children's Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 42 days after initial dose ]

Secondary Outcome Measures:
  • Determine if the safety profile differs between the etanercept treated group and the placebo group. [ Time Frame: 42 days after initial dose ]
  • Determine if Etanercept treatment alters the rate of coronary artery dilation and disease (CAD) defined by z-scores at 2 and 6 weeks after treatment. [ Time Frame: 42 days after initial dose ]
  • Determine the pharmacokinetics of Etanercept in KD patients. [ Time Frame: 42 days after initial dose ]

Estimated Enrollment: 196
Study Start Date: March 2009
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 -Etanercept
Drug - Treatment with Etanercept as adjunct to standard treatment with IVIG and aspirin
Drug: Etanercept
etanercept 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.
Other Name: Enbrel
Placebo Comparator: 2
Drug: Placebo
Placebo 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.

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.

Ages Eligible for Study:   2 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00841789

United States, New York
Feinstein Institute for Medical Rsearch
New Hyde Park, New York, United States, 11040
Columbia University Medical Center
New York, New York, United States, 10032
Montefiore Medical Center
The Bronx, New York, United States, 10467
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Canada, Quebec
Sainte-Justine Hospital
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Michael Portman
Principal Investigator: Michael A Portman, MD Seattle Children's Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael Portman, Cardiologist, Seattle Children's Hospital Identifier: NCT00841789     History of Changes
Other Study ID Numbers: SEA-12652
FD003526 ( Other Grant/Funding Number: FD )
Study First Received: February 10, 2009
Last Updated: May 1, 2017

Keywords provided by Michael Portman, Seattle Children's Hospital:

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors processed this record on May 25, 2017