Clinical Trial: An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Extension Study of CACZ885N2301, Multi-center, Open Label Study of Canakinumab in Japanese Patients With Periodic Fever Syndromes (TRAPS, HIDS, or crFMF)
Brief Summary: The primary objective of this study is to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offers the opportunity for patients who completed Epoch 4 of the preceding CACZ885N2301 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 is suspended.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Number and percentage of patients with adverse events [ Time Frame: Participants will be followed for the duration until approval, an expected average of 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 20, 2016
Date Started: October 3, 2016
Date Completion:
Last Updated: May 11, 2017
Last Verified: May 2017