Periodic Fevers Syndrome Clinical Trial
Official title:
An Extension Study of CACZ885N2301 (NCT02059291), Multi-center, Open Label Study of Canakinumab in Japanese Patients With Periodic Fever Syndromes (Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyper Immunoglobulin D Syndrome ((Also Known as Mevalonate Kinase Deficiency) (HIDS/MKD), or Colchicine Resistant/Intolerant Familial Mediterranean Fever (crFMF))
Verified date | November 2017 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.
Status | Completed |
Enrollment | 4 |
Est. completion date | January 27, 2017 |
Est. primary completion date | January 27, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Japan | Novartis Investigative Site | Fukuoka city | Fukuoka |
Japan | Novartis Investigative Site | Kyoto-city | Kyoto |
Japan | Novartis Investigative Site | Yokohama-city | Kanagawa |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths | Participants were monitored for safety throughout the study. | Participants were followed for the duration until approval, an expected average of 3 months. |