An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
Phase 3
- Conditions
- Hereditary Periodic Fevers
- Registration Number
- JPRN-jRCT2080223341
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
*Completed Epoch 4 of the CACZ885N2301 study in Japan before the approval of canakinumab in Japan
*Written informed consent. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients < 20 years of age
Exclusion Criteria
*Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study
Other protocol defined inclusion/exclusion may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber and percentage of patients with adverse events [ Time Frame: Participants will be followed for the duration until approval, an expected average of 3 months ]<br>To evaluate the safety and tolerability of canakinumab
- Secondary Outcome Measures
Name Time Method