Phase 2
N=205
A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease
Mucocutaneous Lymph Node Syndrome · Kawasaki Disease
Bottom Line
View on ClinicalTrials.gov: NCT00841789 ↗Enrolled (actual)
205
Serious AEs
9.5%
Results posted
May 2023
Primary outcome: Primary: IVIG Refractory — 13; 22 Participants — p=.10
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Etanercept (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Michael Portman
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IVIG Refractory |
13; 22 | .10 |
| SECONDARY Determine if Etanercept Treatment Alters the Rate of Coronary Artery Dilation and Disease (CAD) at 2 and 6 Weeks After Treatment in Patients With Dilated Coro |
56; 53 | 0.86 |
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
Eligibility 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:
- Platelet count 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.
Data sourced from ClinicalTrials.gov (NCT00841789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.