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Etanercept in Kawasaki Disease

Information source: Seattle Children's Hospital
ClinicalTrials.gov processed this data on November 27, 2014
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. Funding Source- FDA/OOPD

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

Montefiore Medical Center, Bronx, New York 10467, United States; Recruiting
Nadine Choueiter, MD, Phone: 718-741-2539, Email: nchoueit@montefiore.org
Kelly A Balem, RN, Phone: 718-741-2384, Email: kbrownb@montefiore.org
Nadine Choueiter, MD, Principal Investigator

Feinstein Institute for Medical Rsearch, New Hyde Park, New York 11040, United States; Completed

Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Lisa F Imundo, MD, Phone: 212-305-9304, Email: lfil@columbia.edu
Monica Sull, MPH, Phone: 212-305-4938, Email: ms4093@cumc.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; 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

Primary Children's Medical Center, Salt Lake City, Utah 84113, United States; Completed

Seattle Children's Hospital, Seattle, Washington 98105, United States; Recruiting
Michael A Portman, MD, Phone: 206-884-1014, Email: michael.portman@seattlechildrens.org
Jeremy Gillis, BS, Phone: 206-884-5153, Email: jeremy.gillis@seattlechildrens.org
Michael A Portman, MD, Principal Investigator

Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53201, United States; Completed

Additional Information

Starting date: March 2009
Last updated: September 15, 2014

Page last updated: November 27, 2014

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