Etanercept in Kawasaki Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Seattle Children's Hospital
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Michael Portman, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00841789
First received: February 10, 2009
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Determine the pharmacokinetics of Etanercept in KD patients. [ Time Frame: 42 days after initial dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 196
Study Start Date: March 2009
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: June 2015 (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
Placebo
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.

  Eligibility

Ages Eligible for Study:   2 Months to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841789

Contacts
Contact: Michael A Portman, MD (206) 884-1014 michael.portman@seattlechildrens.org
Contact: Jeremy Gillis, BS (206) 884-5153 jeremy.gillis@seattlechildrens.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Nadine Choueiter, MD    718-741-2539    nchoueit@montefiore.org   
Contact: Kelly A Balem, RN    718-741-2384    kbrownb@montefiore.org   
Principal Investigator: Nadine Choueiter, MD         
Feinstein Institute for Medical Rsearch Completed
New Hyde Park, New York, United States, 11040
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Lisa F Imundo, MD    212-305-9304    lfil@columbia.edu   
Contact: Monica Sull, MPH    212-305-4938    ms4093@cumc.columbia.edu   
Principal Investigator: Lisa F Imundo, MD         
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Carolyn A Altman, MD    832-826-5682    caaltman@texaschildrens.org   
Contact: Debra Griffin, RN    832-826-5864    dagriffi@mcm.tmc.edu   
Principal Investigator: Carolyn A. Altman, MD         
United States, Utah
Primary Children's Medical Center Completed
Salt Lake City, Utah, United States, 84113
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Michael A Portman, MD    206-884-1014    michael.portman@seattlechildrens.org   
Contact: Jeremy Gillis, BS    206-884-5153    jeremy.gillis@seattlechildrens.org   
Principal Investigator: Michael A Portman, MD         
United States, Wisconsin
Children's Hospital of Wisconsin Completed
Milwaukee, Wisconsin, United States, 53201
Canada, Quebec
Sainte-Justine Hospital Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Nagib Dahdah, MD    514-345-4931 ext 5403    nagib.dahdah.hsj@ssss.gouv.qc.ca   
Contact: Julie Briere, RN    514-345-4931 ext 4573    julie.briere@recherche-ste-justine.qc.ca   
Principal Investigator: Nagib Dahdah, MD         
Sponsors and Collaborators
Michael Portman
Amgen
Investigators
Principal Investigator: Michael A Portman, MD Seattle Children's Hospital
  More Information

No publications provided by Seattle Children's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Portman, Cardiologist, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00841789     History of Changes
Other Study ID Numbers: SEA-12652, FD003526
Study First Received: February 10, 2009
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Children's Hospital:
Etanercept

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014