Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout

For people ages 18-90

To be eligible to be enrolled in the study, each patient must:

1. Provide signed written informed consent
2. Be between 18 and 90 years old
3. Be in a participating primary care practice with at least one visit in the previous 36 months
4. Be diagnosed with gout by the 2015 ACR/EULAR criteria, with 8 or more points on the 2015 ACR/EULAR criteria scoring algorithm
5. Have experienced at least one gout flare attributed in the previous 12 months
6. Have a baseline inter-critical serum urate (SU) ≥ 7.0 mg/dL (at screening or in the 30 days before screening)
7. Be able to swallow pills
8. Agree to practice effective measures of birth control if of reproductive potential.

Exclusion Criteria

Candidates who meet any of the following criteria will be excluded from the study:

1. Diagnosis of CKD Stage 3B or worse (eGFR < 45 mL/min/ 1.73 m2) at screening
2. More than one subcutaneous tophus on clinical examination at screening
3. Two or more episodes of renal colic in the past 5 years
4. Unable to provide a written informed consent
5. ALT > 3 × upper limit of normal (ULN) (within 6 months of entry);
6. Pregnancy, planning pregnancy, or breastfeeding;
7. Taking mercaptopurine (PURINETHOL®) or azathioprine (IMURAN®);
8. Unlikely to survive 2 years because of comorbidities;
9. Currently taking > 200 mg of allopurinol per day or any dose of febuxostat. Patients taking 200 mg or less of allopurinol daily may participate, provided they meet the eligibility criteria for flares and current SU, and they have not had a dose escalation in their allopurinol in the previous 6 months
10. Patients with known allergic or hypersensitive reactions to allopurinol and not willing to initiate febuxostat if urate lowering is indicated; or
11. Subjects that test positive for HLA-B*5801 allele, a genetic marker for severe cutaneous adverse reactions caused by allopurinol and are unwilling to initiate febuxostat if urate lowering is indicated by the study. Subjects of higher risk, including Black/African American, Asian (except Japanese), native Hawaiian, or Pacific Islander descent will be tested at screening.

Candidates who meet any of the following criteria will be excluded from the study:

• Diagnosis of chronic kidney disease (CKD) Stage 3B or worse (eGFR < 45 mL/min/ 1.73 m2) at screening;
• More than one subcutaneous tophus on clinical examination at screening;
• Two or more episodes of renal colic in the past 5 years;
• Unable to provide a written informed consent;
• alanine aminotransferase (ALT) > 3 × upper limit of normal (ULN) (within 6 months of entry);
• Pregnancy, planning pregnancy, or breastfeeding;
• Taking mercaptopurine (PURINETHOL®) or azathioprine (IMURAN®);
• Unlikely to survive 2 years because of comorbidities; or
• Currently taking > 200 mg per day of allopurinol. Patients taking 200 mg or less of allopurinol daily may participate, provided they meet the eligibility criteria for flares and current SU, and they have not had a dose escalation in their allopurinol in the previous 6 months.