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)

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.