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

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 3, 2021

Keywords

ClinConnect Summary

The TRUST study is a clinical trial aimed at finding the best way to manage gout, a painful condition caused by high levels of uric acid in the blood. Researchers want to compare two treatment strategies: one that focuses on lowering uric acid levels to a specific target and another that aims to prevent symptoms of gout from occurring. By doing this, the study hopes to understand which approach leads to better overall health outcomes for patients, including aspects related to heart and kidney health.

To join the study, participants must be between 18 and 90 years old and have been diagnosed with gout. They should have had at least one gout flare in the past year and have a certain level of uric acid in their blood. Participants will need to be able to take medication by mouth and provide consent to join the trial. Those who qualify can expect regular visits and monitoring over the course of the study. It’s important to note that individuals with certain health conditions or who are taking specific medications may not be eligible to participate. If you think you might be a good fit for this study, please talk to your doctor for more information.

Gender

ALL

Eligibility criteria

• To be eligible to be enrolled in the study, each patient must:
• • 1. Provide signed written or electronic 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) ≥ 6.0 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 informed consent.
• • 5. AST/ALT \> 3 × upper limit of normal (ULN) (within 6 months of entry).
• • 6. Pregnancy, planning pregnancy, or breastfeeding.
• • 7. 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.
• • 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.
• • 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.