Allopurinol vs. Febuxostat Non-Inferiority in Gout Treatment: A Treat-to-Target Approach

Study start date: March 6, 2017

Inclusion Criteria: * Age 18 years * History of gout - crystal proven or historical as defined by ACR criteria listed above * Serum urate level \> 6.8 mg/dl Exclusion Criteria: * Stage 4 or 5 Chronic Kidney Disease (CKD) - defined as eGFR \< 30 ml/min/1.73 m2 * Women less than 50 years of age * Patients with a history of prior solid organ / hematopoietic transplantation * Previous allergy or intolerance to allopurinol or febuxostat * Patients who are not candidates for any of the recommended prophylactic medications (colchicine, naprosyn or glucocorticoids) * Patients who in the opinion of the investigator have a high genetic risk for allopurinol hypersensitivity syndrome (AHS\*) unless they have been found to be negative for HLA B5801. * Previous history of failure to reach target uric acid levels despite therapy with allopurinol at dose \> 300 mg/day * Prior febuxostat use * Patients with malignancies that are currently active with exception of non-melanoma skin cancer * Patients with serum uric acid levels \>15 mg/dl * Patients with myelodysplasia and hemoglobin of \< 8.5 mg/dL * Patients with chronic liver disease with more than one of the following: * INR \> 1.7, not on Warfarin therapy * Bilirubin 2 mg/dL * Serum albumin \< 3.5 mg/dL * Ascites * Encephalopathy * Current use of azathioprine, mercaptopurine, didanosine, cyclophosphamide, probenecid, lesinurad or pegloticase * Enrollment in another randomized interventional clinical trial * Any severe medical condition that, in the enrolleer's opinion, is likely to compromise the participant's ability to complete the trial