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

Recruiting now · Phase 4

Conditions studied: Gout

In brief

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.

Key facts

Study ID

NCT04875702

Run by

Massachusetts General Hospital

People needed

650

Starts

2024-02-22

Expected to finish

2028-10-31

Last updated by the study team

2025-09-25

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Brigham and Women's Hospital (BWH) — Boston, Massachusetts, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• NYU Langone — New York, New York, United States (enrolling)
• The University of Alabama at Birmingham — South Birmingham, Alabama, United States
• Boston Medical Center (BMC) — Boston, Massachusetts, United States
• UCLA Health — Santa Monica, California, United States
• West Virginia University (Including Mobile Clinical Trials Unit) — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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