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

Completed · Phase 2 · Has a placebo group

Conditions studied: Mucocutaneous Lymph Node Syndrome, Kawasaki Disease

In brief

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

Key facts

Study ID

NCT00841789

Run by

Michael Portman

People needed

205

Starts

2009-03-01

Expected to finish

2018-08-30

Last updated by the study team

2023-05-06

Who can join

Age: 0 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• Platelet count < 100,000/mm3
• WBC count < 3,000 cells/mm3
• 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.

Where it is running

• Feinstein Institute for Medical Rsearch — New Hyde Park, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Texas Children's Hospital — Houston, Texas, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• Sainte-Justine Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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