Clinical Trial: β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated

Brief Summary: This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: safety and tolerability [ Time Frame: 18 months ]

long-term safety and tolerability of canakinumab


Original Primary Outcome: Safety and tolerability of canakinumab [ Time Frame: 18 months ]

Safety and tolerability will be evaluated by summarizing adverse events (including infections and malignancies), vital signs and laboratory data in patients exposed to canakinumab


Current Secondary Outcome: long-term efficacy [ Time Frame: 18 months ]

long-term efficacy of canakinumab defined as frequency of new flares


Original Secondary Outcome:

  • Long-term efficacy of canakinumab defined as frequency of new flares [ Time Frame: 18 months ]
    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 ]
    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 ]
    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 ]
    hsCRP will be measured at scheduled (every 6 months) and unscheduled visits (flare/control visits)
  • Immunogenicity of canakinumab [ Time Frame: 18 months ]
    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 ]
    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


Information By: Novartis

Dates:
Date Received: August 16, 2011
Date Started: November 2011
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017