A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)
Condition: Gout
MeSH terms: Gout
Intervention: Canakinumab; Colchicine; Allopurinol; Placebo Matching Canakinumab; Placebo Matching Colchicine
Intervention description: Canakinumab was supplied in glass vials as a lyophilized powder.; 0.5 mg capsule orally once daily for 16 weeks.; 100-300 mg orally once daily for 24 weeks.; Subcutaneous injection.; Capsule orally once daily for 16 weeks.
Intervention MeSH terms: Colchicine; Allopurinol; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 432.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Gout; Chronic gout; Gouty arthritis; Gout flares

Summary:

      The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core
      study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute
      flares in chronic gout patients initiating allopurinol therapy. The core study was followed
      by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and
      efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout
      flare.
    

Eligibility criteria:

        Core study

        Inclusion Criteria:

          -  Signed written informed consent before any study procedure is performed.

          -  History of at least 2 gout flares in the year prior to Screening (Visit 1, based on
             patient history), thus, candidates for initiating uric acid lowering therapy.

          -  Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977
             preliminary criteria for the classification of arthritis of primary gout.

          -  Body Mass Index (BMI) ≤ 40 kg/m^2.

          -  Willingness to initiate allopurinol therapy as urate lowering agent for their gout
             therapy or having initiated allopurinol therapy within ≤ 1 month before Screening
             (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months
             before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of
             efficacy.

        Exclusion Criteria:

          -  Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening
             period.

          -  History of allergy or contraindication to colchicine or allopurinol.

          -  History of intolerance to allopurinol or to oral colchicine in appropriate dose for
             prophylactic use.

          -  History of bone marrow suppression.

          -  Absolute or relative contraindication to both naproxen and oral prednisolone/
             prednisone.

        Extension study

        Inclusion criteria:

          -  Patients who completed the core study. A patient is defined as completing the core
             study if he/she completed the study up to and including the last visit (Visit 9).

          -  Patients who have signed a written informed consent before any trial procedure is
             performed.

        Exclusion Criteria:

          -  Patients for whom continuation in the extension study is not considered appropriate by
             the treating physician.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive pregnancy test (serum or urine).

        Other protocol-defined inclusion/exclusion criteria applied to the study.