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 Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks 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: 230.0
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 the 12-week core 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 CACZ885H2356.

      The purpose of the second 48 week open-label extension study was to collect additional
      long-term safety and tolerability data in patients who have completed the first extension
      study CACZ885H2356E1.
    

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, intolerance, or lack of efficacy for non-steroidal anti-inflammatory
             drugs (NSAIDs) 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 Completed of the first extension study CACZ885H2356E1. A patient was defined as
        completing the first extension study if they completed the study up to and including Visit
        10).

        Exclusion

        -Continuation in this extension study was considered inappropriate by the treating
        physician

        Other protocol-defined inclusion-exclusion criteria applied to the core and extension
        studies.