The objective of this extension protocol is to collect safety data (serious and non-serious adverse events) and to provide continuous canakinumab to patients in France who completed study CACZ885G2301E1(NCT00891046), CACZ885G2306 (NCT02296424) or CACZ885N2301 (NCT02059291) until a decision regarding reimbursement in France is effective for canakinumab (Ilaris®) in these indications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
canakinumab
Novartis Investigative Site
Bron, France
Novartis Investigative Site
Le Kremlin-Bicêtre, France
Novartis Investigative Site
Paris, France
Number of Participants With Adverse Events
The objective of this protocol was to collect additional safety data (serious and non serious AEs) and to provide continuous Ilaris® (canakinumab) treatment to patients in France who completed CACZ885G2301E1, CACZ885N2301 or CACZ885G2306 studies.
Time frame: every 4 weeks up to 1 year
All-cause Mortality
Number of participants who died for any reason during the study
Time frame: uo to 1 year
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