Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.
Condition: Acute Gout
MeSH terms: Gout
Intervention: Canakinumab 150 mg; Triamcinolone acetonide 40 mg; Placebo to canakinumab; Placebo to triamcinolone acetonide
Intervention description: Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).; Triamcinolone acetonide 40 mg was supplied as a suspension.; Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophilized cake.; Placebo triamcinolone acetonide was supplied as a lipid emulsion similar in appearance to triamcinolone acetonide.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Antibodies, Monoclonal; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Frequent flares; Gout; Anti-interleukin-1β monoclonal antibody

Summary:

      The purpose of this study was to demonstrate that canakinumab given upon acute gout flares
      relieves the signs and symptoms and prevents recurrence of gout flares in patients with
      frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or
      colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab
      was compared to the corticosteroid triamcinolone acetonide.

      The purpose of the first 12 week extension study was to collect additional safety,
      tolerability and efficacy data in patients who have completed the core study CACZ885H2357.

      The purpose of the second one year open-label extension study was to confirm the long-term
      safety and tolerability of canakinumab in patients who had completed the first extension
      study.
    

Eligibility criteria:

        Core Study:

        Inclusion criteria:

          -  Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the
             classification of acute arthritis of primary gout

          -  Onset of current acute gout flare within 5 days prior to study entry

          -  Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)

          -  History of ≥ 3 gout flares within the 12 months prior to study entry

          -  Contraindication, or intolerance, or lack of efficacy for non-steroidal
             anti-inflammatory drugs (NSAID) and/or colchicine

        Exclusion criteria:

          -  Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other
             acute inflammatory arthritis

          -  Presence of severe renal function impairment

          -  Use of specified pain relief medications or biologics (corticosteroids, narcotics,
             paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis
             factor inhibitor within specified periods prior to study entry

          -  Live vaccinations within 3 months prior to randomization

          -  Requirement for administration of antibiotics against latent tuberculosis (TB)

          -  Refractory heart failure (Stage D)

          -  Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia

          -  Any active or recurrent bacterial, fungal, or viral infection

        Extension Study 1:

        Inclusion:

        - Completion of the Core study. A patient was defined as completing the core study if they
        completed the study up to and including visit 7.

        Exclusion:

        - Continuation in this extension study was considered inappropriate by the treating
        physician.

        Extension Study 2:

        Inclusion Criteria:

          -  Completion of the first extension study CACZ885H2357E1. A patient was defined as
             completing the first extension study if they completed the study up to and including
             Visit 10).

        Exclusion Criteria:

        -Continuation in this second extension study was considered inappropriate by the treating
        physician.

        Other protocol-defined inclusion-exclusion criteria applied to the core and extension
        studies.