Comparing two treatment strategies for managing gout

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the management of gout by comparing two treatment strategies: treating to target serum urate levels versus treating to avoid symptoms. It is a randomized, controlled multicenter study designed to determine which approach yields better patient-centered outcomes and relevant cardiovascular, metabolic, and renal endpoints. The trial is conducted in primary care settings, allowing for a pragmatic approach that can be generalized to everyday practice. Input from a diverse panel of healthcare professionals and patients was incorporated to ensure the study addresses key issues in gout management.

Why it matters

Who can join: the full rules

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.

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Brigham and Women's Hospital (BWH)
  Boston, Massachusetts, United States Recruiting
• NYU Langone
  New York, New York, United States Recruiting
• The University of Alabama at Birmingham
  South Birmingham, Alabama, United States Not yet recruiting
• UCLA Health
  Santa Monica, California, United States Not yet recruiting
• Boston Medical Center (BMC)
  Boston, Massachusetts, United States Not yet recruiting

Study contacts

• Principal investigator: Hyon K Choi, MD, PhD — Massachusetts General Hospital
• Study coordinator: Ana D Fernandes, MA
• Email: adfernandes@mgh.harvard.edu
• Phone: 617-643-2140

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Remote monitoring for gout in primary care

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• Purified Cortrophin® Gel for treating acute gout flares at two dose levels

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• IV PRX-115 at different dose schedules, with or without methotrexate, versus placebo for adults with gout

  This trial will test whether IV PRX-115 given on different schedules, with or without low-dose methotrexate, can lower uric acid and be safe in adults whose gout is not controlled by standard urate-lowering drugs.

  Recruiting at 35 sites Phase 2 Protalix · Glendale, Arizona and 34 other locations · NCT07280156

• Dotinurad versus allopurinol for lowering uric acid in gout

  This trial tests whether dotinurad lowers blood uric acid more than allopurinol in adults with gout.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.