oncontrolled open-label exploratory clinical trial of additional infliximab therapy for patients with refractory Kawasaki disease who are refractory to intravenous immunoglobulin therapy, additional intravenous immunoglobulin therapy and first infliximab therapy.
- Conditions
- Kawasaki disease
- Registration Number
- JPRN-UMIN000027523
- Lead Sponsor
- Shinshu University School of Medicine
- Brief Summary
Additional infliximab was administered to 5 patients with refractory Kawasaki disease. Fever was resolved in 2 cases and it was judged that there was an effect. The other 3 cases were judged to be refractory due to fever persistence and additional treatment was performed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Not provided
1. Example which was ineligible for the first infliximab administration 2. Patients with severe infectious complications or sepsis 3. Patients with a history of demyelinating disease 4. Patients with a history of malignant tumors 5. Patients with a history of tuberculosis infection or tuberculosis 6. Patients with less than 6 months after BCG vaccination 7. Patients with less than 1 month after live vaccination 8. Patients who showed allergy symptoms in the first infliximab administration 9. Patients with congestive heart failure 10. Patients who are receiving steroids or other immunosuppressants 11. In addition, patients whose research managers judged inappropriate as subjects
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence or absence of fever exceeding 37.5 degrees Celsius
- Secondary Outcome Measures
Name Time Method Presence or absence of coronary artery lesion, safety of infliximab administration, and presence or absence of infection during 3 months after administration.