Etanercept in Kawasaki Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 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: November 11, 2013
Last verified: November 2013

February 10, 2009
November 11, 2013
March 2009
June 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00841789 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Etanercept in Kawasaki Disease
A Randomized, Double Blind, Placebo Controlled Study of the Effects of Etanercept in Children Presenting With Kawasaki Disease

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Mucocutaneous Lymph Node Syndrome
  • Kawasaki Disease
  • 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
  • Drug: Placebo
    Placebo 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.
  • Experimental: Arm 1 -Etanercept
    Drug - Treatment with Etanercept as adjunct to standard treatment with IVIG and aspirin
    Intervention: Drug: Etanercept
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Portman MA, Olson A, Soriano B, Dahdah N, Williams R, Kirkpatrick E. Etanercept as adjunctive treatment for acute Kawasaki disease: study design and rationale. Am Heart J. 2011 Mar;161(3):494-9. doi: 10.1016/j.ahj.2010.12.003.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
196
March 2016
June 2015   (final data collection date for primary outcome measure)

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.
Both
2 Months to 20 Years
No
Contact: Michael A Portman, MD (206) 884-1014 michael.portman@seattlechildrens.org
Contact: Miriam Silva, MD/BS (206) 884-5153 miriam.silva@seattlechildrens.org
United States,   Canada
 
NCT00841789
SEA-12652, FD003526
Yes
Michael Portman, Seattle Children's Hospital
Michael Portman
Amgen
Principal Investigator: Michael A Portman, MD Seattle Children's Hospital
Seattle Children's Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP