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

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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 CV-metabolic-renal endpoints.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Allopurinol; Anti-Inflammatory Agents

Criteria

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

1. Be 18 years or older; 2. Be in a participating primary care practice with at least one visit in the previous 36 months; 3. Be diagnosed with gout by the 2015 ACR/EULAR criteria, with 8 or more points on the 2015 ACR/EULAR criteria scoring algorithm; 4. Have experienced at least one gout flare attributed in the previous 12 months; and 5. Have a baseline inter-critical serum urate (SU) ≥ 7.0 mg/dL (in the previous 6 months).

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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; or

9. 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.