Etanercept in Kawasaki Disease
Information source: Seattle Children's Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mucocutaneous Lymph Node Syndrome; Kawasaki Disease
Intervention: Etanercept (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Michael Portman Official(s) and/or principal investigator(s):
Michael A Portman, MD, Principal Investigator, Affiliation: Seattle Children's Hospital
Overall contact:
Michael A Portman, MD, Phone: (206) 884-1014, Email: michael.portman@seattlechildrens.org
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.
Clinical Details
Official title: A Randomized, Double Blind, Placebo Controlled Study of the Effects of Etanercept in Children Presenting With Kawasaki Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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.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. Determine the pharmacokinetics of Etanercept in KD patients.
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
Minimum age: 2 Months.
Maximum age: 20 Years.
Gender(s): Both.
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.
Locations and Contacts
Michael A Portman, MD, Phone: (206) 884-1014, Email: michael.portman@seattlechildrens.org
Steven & Alexandra Cohen Children's Medical Center of New York, New Hyde Park, New York 11040, United States; Recruiting
Deborah Mensch, MD, Phone: 718-470-7350, Email: DMensch@nshs.edu
Dorota Gruber, MS, GC, Phone: 718-470-7350, Email: dgruber1@nshs.edu
Deborah Mensch, MD, Principal Investigator
Columbia University Medical Center, New York, New York 10032, United States; Not yet recruiting
Lisa F Imundo, MD, Phone: 212-305-9304, Email: lfil@columbia.edu
Lisa F Imundo, MD, Principal Investigator
Sainte-Justine Hospital, Montreal, Quebec H3T 1C5, Canada; Recruiting
Nagib Dahdah, MD, Phone: 514-345-4931, Ext: 5403, Email: nagib.dahdah.hsj@ssss.gouv.qc.ca
Julie Briere, RN, Phone: 514-345-4931, Ext: 4573, Email: julie.briere@recherche-ste-justine.qc.ca
Nagib Dahdah, MD, Principal Investigator
Texas Children's Hospital, Houston, Texas 77030, United States; Not yet recruiting
Carolyn A Altman, MD, Phone: 832-826-5682, Email: caaltman@texaschildrens.org
Debra Griffin, RN, Phone: 832-826-5864, Email: dagriffi@mcm.tmc.edu
Carolyn A. Altman, MD, Principal Investigator
Seattle Children's Hospital, Seattle, Washington 98105, United States; Recruiting
Michael A Portman, MD, Phone: 206-884-1014, Email: michael.portman@seattlechildrens.org
Miriam Silva, MD, Phone: 206-884-5153, Email: miriam.silva@seattlechildrens.org
Michael A Portman, MD, Principal Investigator
Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53201, United States; Recruiting
Edward Kilpatrick, DO, Phone: 414-456-8296, Email: EKirkpatrick@chw.org
Mary Krolikowski, RN, MSN, Phone: 414-266-2093, Email: mkrolikowski@chw.org
Edward Kilpatrick, DO, Principal Investigator
Additional Information
Starting date: March 2009
Last updated: April 25, 2012
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