Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

Inclusion criteria:

- 3 or more gout flares within last year

- Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine

- Body mass index of less than or equal to 45 kg/m2

Exclusion criteria:

- Use of the following therapies (within varying protocol defined timeframes):
corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs
(such as aspirin), colchicine.

- Hemodialysis

- Live vaccine within 3 months before first dose

- Donation or loss of 400 mL or more within 3 months before first dose

- Gout brought on by other factors such as chemotherapy, lead, transplant, etc.

- Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis

- Any conditions or significant medical problems that puts the patient at an
unacceptable immunological risk to receive this type of therapy such as HIV,
Hepatitis, Tuberculosis and other infections/conditions

- Significant cardiovascular conditions such as uncontrolled hypertension

- Significant medical diseases such as uncontrolled diabetes, thyroid disease

- History of malignancy of any organ system within the past 5 years

- Women who are pregnant or nursing

- Other protocol-defined inclusion/exclusion criteria may apply