Status:
RECRUITING
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Gout
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief 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 benef...
Detailed Description
This trial aims to answer a fundamental question in the management of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to determine which is most beneficial for a range...
Eligibility Criteria
Inclusion
- To be eligible to be enrolled in the study, each patient must:
- Provide signed written or electronic informed consent.
- Be between 18 and 90 years old.
- Be in a participating primary care practice with at least one visit in the previous 36 months.
- Be diagnosed with gout by the 2015 ACR/EULAR criteria, with 8 or more points on the 2015 ACR/EULAR criteria scoring algorithm.
- Have experienced at least one gout flare attributed in the previous 12 months.
- Have a baseline inter-critical serum urate (SU) ≥ 6.0 mg/dL (at screening or in the 30 days before screening)
- Be able to swallow pills.
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
February 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT04875702
Start Date
February 22 2024
End Date
October 31 2028
Last Update
September 25 2025
Active Locations (7)
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1
The University of Alabama at Birmingham
South Birmingham, Alabama, United States, 35233
2
UCLA Health
Santa Monica, California, United States, 90404
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Brigham and Women's Hospital (BWH)
Boston, Massachusetts, United States, 02115