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

About

Brief Summary

The TRUST study is a randomized, controlled multicenter study to evaluate the management of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to determine the most beneficial for a patient-centered gout outcomes, as well as relevant cardiovascular-metabolic-renal endpoints.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 4

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

90 Years

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

Provide signed written or electronic informed consent.
Be between 18 and 90 years old.
Be in a participating primary care practice with at least one visit in the previous 36 months.
Be diagnosed with gout by the 2015 ACR/EULAR criteria, with 8 or more points on the 2015 ACR/EULAR criteria scoring algorithm.
Have experienced at least one gout flare attributed in the previous 12 months.
Have a baseline inter-critical serum urate (SU) ≥ 6.0 mg/dL (at screening or in the 30 days before screening)
Be able to swallow pills.
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:

Diagnosis of 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 informed consent.
AST/ALT > 3 × upper limit of normal (ULN) (within 6 months of entry).
Pregnancy, planning pregnancy, or breastfeeding.
Patients who have been treated with thiopurines (mercaptopurine (PURINETHOL®), azathioprine (IMURAN®), or thioguanine) in the past 12 months or currently being treated with thiopurines are not eligible for the study. Usage of the thiopurines (azathioprine and mercaptopurine) with allopurinol has been shown to cause a significant drug-drug interaction.
Unlikely to survive 2 years because of comorbidities.
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.
Patients with known allergic or hypersensitive reactions to allopurinol and not willing to initiate febuxostat if urate lowering is indicated.
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.