Allopurinol Outcome Study

Inclusion Criteria: * Meets the diagnosis of gout according to the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout. * Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening. * If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening. * Must have had at least 2 gout flares in the past year. Exclusion Criteria: * Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz \[150 mL\] of wine, 12 oz \[360 mL\] of beer, or 1.5 oz \[45 mL\] of hard liquor). * History or suspicion of drug abuse. * History of autoimmune disease requiring systemic treatment. * Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or hepatitis B antibody (HBsAg) infection. * History of malignancy within the previous 5 years (with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer). * Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure, or stroke within the last 12 months. * Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure above 95 mm Hg). * Estimated creatinine clearance \< 30 mL/min by Cockcroft-Gault formula. * Kidney or other organ transplant. * Active peptic ulcer disease requiring treatment. * History of xanthinuria, active liver disease, or hepatic dysfunction. * If unable to take gout flare prophylaxis of either colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal function, use of contraindicated medications). * Known hypersensitivity or allergy to allopurinol.