Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Key facts
- Where
- Boston, Morgantown, New York, Santa Monica, and South Birmingham, United StatesSee the 7 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT04875702, who can take part
Where in United States
- Boston Medical Center (BMC)Boston, United StatesContact: Julien J Dedier, MD, MPHNot yet recruiting
- Brigham and Women's Hospital (BWH)Boston, United StatesContact: Daniel H Solomon, MD, MPHTaking people
- Massachusetts General HospitalBoston, United StatesContact: Ana D Fernandes, MATaking people
- West Virginia University (Including Mobile Clinical Trials Unit)Morgantown, United StatesContact: Sally Hodder, MDNot yet recruiting
- NYU LangoneNew York, United StatesContact: Michael Pillinger, MDTaking people
- UCLA HealthSanta Monica, United StatesContact: John Fitzgerald, MD, PhDNot yet recruiting
- The University of Alabama at BirminghamSouth Birmingham, United StatesContact: Kenneth Saag, MD, MScNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT04875702
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial
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.
Exclusion: 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; 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; Diagnosis of CKD Stage 3B or worse (eGFR < 45 mL/min/ 1.73 m2) at screening; AST/ALT > 3 × upper limit of normal (ULN) (within 6 months of entry); Candidates who meet any of the following criteria will be excluded from the study:; 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; Pregnancy, planning pregnancy, or breastfeeding; Unlikely to survive 2 years because of comorbidities; 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.
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.