NCT04875702 · Massachusetts General Hospital
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
(TRUST)
What this study is about
The TRUST study is a randomly assigned, controlled conducted at multiple hospitals 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.
View original scientific 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.
Interventions
DRUG
Allopurinol
For the TTT-SU group: The dose titration algorithm for allopurinol increases every 4 weeks by 100 mg until the target serum urate of 6 mg/dL is reached or a patient requires 800 mg per day of allopurinol. Subjects will require a blood draw for SU every 4 weeks until reaching the target. For the TTASx group: Subjects randomized to the TTASx group will receive anti-inflammatory treatments (naproxen, colchicine, and/or prednisone) for up to six flares over the ensuing three months. Urate lowering therapy (ULT) will only be offered after the third flare during the trial.
DRUG
Naproxen 250 MG
Naproxen 250 mg p.o. twice daily
DRUG
Colchicine 0.6 mg
Colchicine 0.6 mg p.o. once daily
DRUG
Colchicine 1.2 mg
Dose escalation to 0.6 mg p.o. twice daily for patients experiencing breakthrough flares or a dose decrease (0.6 mg p.o. every other day) for patients experiencing gastrointestinal intolerance.
DRUG
Naproxen 500 Mg
dose escalation to 500 mg twice daily for patients experiencing breakthrough flares.
DRUG
Prednisone 40 mg
For flare glucocorticoids: prednisone taper for 8 days, starting with 40mg (oral) daily.
Primary outcome measures
Frequency of gout flare
Time frame: baseline to two years of follow up
number of gout flares occurring during two years of follow-up between the TTT-SU and TTASx groups
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
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
Where
- South Birmingham, Alabama
- Santa Monica, California
- Boston, Massachusetts
- New York, New York
- Morgantown, West Virginia
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2025 · Source of record for eligibility and locations