Actively Recruiting
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Led by Massachusetts General Hospital · Updated on 2025-09-25
650
Participants Needed
7
Research Sites
244 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 cardiovascular-metabolic-renal endpoints.
CONDITIONS
Official Title
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, scoring 8 or more points.
- Have experienced at least one gout flare in the previous 12 months.
- Have a baseline serum urate level of 6.0 mg/dL or higher within 30 days before screening.
- Be able to swallow pills.
- Agree to use effective birth control if of reproductive potential.
You will not qualify if you...
- Diagnosis of chronic kidney disease Stage 3B or worse (eGFR less than 45 mL/min/1.73 m2) at screening.
- More than one subcutaneous tophus found during clinical examination at screening.
- Two or more episodes of kidney stones (renal colic) in the past 5 years.
- Unable to provide informed consent.
- Elevated liver enzymes with AST/ALT more than three times the upper limit of normal within 6 months before entry.
- Pregnancy, planning pregnancy, or currently breastfeeding.
- Treatment with thiopurines (mercaptopurine, azathioprine, or thioguanine) in the past 12 months or currently.
- Expected survival less than 2 years due to other health conditions.
- Currently taking more than 200 mg of allopurinol daily or any dose of febuxostat.
- Known allergy or hypersensitivity to allopurinol and unwilling to start febuxostat if needed.
- Positive test for HLA-B*5801 allele and unwilling to start febuxostat if urate lowering is needed; higher-risk ethnicities will be tested.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
The University of Alabama at Birmingham
South Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
UCLA Health
Santa Monica, California, United States, 90404
Not Yet Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Brigham and Women's Hospital (BWH)
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Boston Medical Center (BMC)
Boston, Massachusetts, United States, 02119
Not Yet Recruiting
6
NYU Langone
New York, New York, United States, 10010
Actively Recruiting
7
West Virginia University (Including Mobile Clinical Trials Unit)
Morgantown, West Virginia, United States, 26506
Not Yet Recruiting
Research Team
A
Ana D Fernandes, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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