Noncontrolled 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.

Noncontrolled 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. - Noncontrolled 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027523

Enrollment

Registered

2017-06-01

Start date

2017-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kawasaki disease

Interventions

Infliximab is administered intravenously in 2 hours as a dose of 5 mg per kg of body weight.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Kawasaki disease patient who is refractory to intravenous immunoglobulin therapy and additional intravenous immunoglobulin therapy and refractory to initial infliximab therapy

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Presence or absence of fever exceeding 37.5 degrees Celsius	—

Secondary

Measure	Time frame
Presence or absence of coronary artery lesion, safety of infliximab administration, and presence or absence of infection during 3 months after administration.	—

Countries

Japan

Contacts

Public ContactYuuka Miyajima

Shinshu University School of Medicine Pediatrics

miyajima@shinshu-u.ac.jp0263-37-2642

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026