An Open-label Extension Study With Canakinumab on the Treatment and Prevention of Gout Flares up to 3 Years (B-Relieved)

• Long-term efficacy of canakinumab defined as frequency of new flares [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  Flare rate will be calculated as the number of new gout flares over the period of observations in years
• Long-term efficacy of canakinumab defined as Patient's assessment of gout pain intensity (Likert scale) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  Patient's assessment of gout pain intensity (Likert scale) will be measured on a daily basis over 14 days after each new flare starting one day after re-dosing until control visit
• Long-term efficacy of canakinumab defined as global assessment of response to treatment (Likert scale) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  Global assessment of response to treatment (Likert scale) will be measured on a daily basis over 14 days after each new flare starting one day after re-dosing until control visit
• Long-term efficacy of canakinumab with regards to inflammatory markers (high sensitivity C-reactive protein) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  hsCRP will be measured at scheduled (every 6 months) and unscheduled visits (flare/control visits)
• Immunogenicity of canakinumab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  Immunogenicity will be assessed at scheduled (every 6 months) and unscheduled visits (flare visits)
• Safety in the concomitant use of canakinumab with different urate lowering therapy regimens [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  Safety in the concomitant use with different ULT regimens will be evaluated by summarizing adverse events (including infections and malignancies), urate lowering concomitant medications, vital signs and laboratory data in patients initiating or modifying their urate lowering therapy while exposed canakinumab

The purpose of this third extension study is to provide additional long-term safety and tolerability data of canakinumab over an 18-month time period on patients who have completed the extension studies CACZ885H2356E2 and CACZ885H2357E2. Overall, the treatment and follow-up period from the initial baseline visit in the core studies, and all subsequent extensions will amount to a total of up to 3 years.The study will provide additional safety data of repeated treatment with on-demand use of canakinumab in patients with gouty arthritis. The study may further be used to optimize patients' Urate Lowering Therapy (ULT) as needed, and collect further safety data on the concomitant use of canakinumab with different ULT regimens.

Inclusion criteria:

• Patients who have completed the second extension studies
• Patients who have already been treated with canakinumab in the core studies or subsequent extensions

Exclusion criteria:

• Continuation in this extension study is considered inappropriate by the treating physician
• Other protocol-defined inclusion/exclusion criteria may apply