Severe Gout Registry (SGR)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC08) canakinumab

  canakinumab
• Medical condition to be studied:
  Gouty arthritis

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  To characterize the users, use and safety profile of canakinumab in the gouty arthritis population in the Netherlands and to mirror these results against a standard of care cohort of patients with frequent gout flares, not receiving canakinumab.
• Outcomes:
  To explore the overall efficacy and safety profile of canakinumabunder conditions of routine clinical care and provide data on the incidence rates of selected safety related outcomes in the population of frequently flaring gout flares and to mirror the results against a cohort of frequently flaring gout patients under standard care.
• Data analysis plan:
  Descriptive statistics will be used to summarize all safety and effectiveness criteria. No formal hypothesis testing or statistical significance testing is planned. The primary analyses will include evaluating the frequency (proportions or rates and 95% CI) of serious infections, malignancies, hypersensitivity reactions and other selected events. Additional analyses will explore the frequency of markers of diseaseprogression, such as to be determined and the frequency of other SAEs considered potentially related to canakinumab or standard of care.