Clinical Trial: Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

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

Official Title: A 36-week Open-label Extension Study of CACZ885H2361 on the Safety and Tolerability of Canakinumab 150 mg s.c. Pre-filled Syringe (PFS) in Treating Acute Gouty Arthritis F

Brief Summary: This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Safety and tolerability of repeated dosing of canakinumab 150mg s.c. PFS [ Time Frame: 36 weeks ]

Frequency and severity of adverse event reports in patients who have received repeat dosing of canakinumab 150mg s.c. PFS


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Immunogenicity of repeated dosing of canakinumab 150mg s.c. PFS [ Time Frame: 36 weeks ]
    Presence or absence of Anti-ACZ885 antibody concentrations will be measured in patients who have received repeated dosing of canakinumab 150mg s.c. PFS
  • The time to the first new gouty arthritis flare since the entry into the core study [ Time Frame: 36 weeks ]
    Time will be measured to the onset of the first gouty arthritis flare from the time of the initial dose of study drug in the CACZ885H2361 core study.
  • Frequency of new gouty arthritis flares [ Time Frame: 36 Weeks ]
    The number of gouty arthritis flares will be recorded for the duration of the trial
  • Signs and symptoms of new gouty arthritis flares [ Time Frame: 36 Weeks ]
    Likert and visual analogue (VAS) pain scales, patient and physician global assessment scales and the physician's assessment of tenderness, swelling and erythema of the most affected joint will be collected during every gouty arthritis flare and at the end of the study.
  • Pharmacokinetics (PK) of canakinumab 150mg s.c. PFS [ Time Frame: 36 Weeks ]
    PK assessments at various time points will be carried out to characterize the PK properties of the PFS form of canakinumab, as well as provide supporting data in the interpretation of any immunogenicity findings.


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: August 30, 2011
Date Started: August 2011
Date Completion:
Last Updated: March 20, 2017
Last Verified: March 2017