Comparing two treatment strategies for managing gout

Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial

This study is testing whether treating gout by aiming for specific blood urate levels works better than just focusing on avoiding symptoms for people with the condition.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 650 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 7 sites (South Birmingham, Alabama and 6 other locations)
• Trial ID: NCT04875702 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with a confirmed diagnosis of gout who have experienced at least one flare in the past year.

Not a fit: Patients with chronic kidney disease Stage 3B or worse, or those with multiple subcutaneous tophi, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for gout, enhancing patient outcomes and quality of life.

How similar studies have performed: While there have been studies on gout management, this specific comparison of treatment strategies is novel and has not been extensively tested.

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.

Where this trial is running

South Birmingham, Alabama and 6 other locations

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

Study contacts

• Principal investigator: Hyon K Choi, MD, PhD — Massachusetts General Hospital
• Study coordinator: Ana D Fernandes, MA

Conditions Gout