No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 90
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
650 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 90 with gout who want to help find the best way to manage their condition. Participants will compare two treatment methods to see which one helps more with gout symptoms and overall health.
Are You a Good Fit for This Trial?
Must not be takingThiopurines
Rules you outChronic Kidney Disease Stage 3B or worse
You may be able to join if
I am between 18 and 90 years old.
I have been diagnosed with gout.
I have had a gout flare in the past year.
I have a serum urate level of 6.0 mg/dL or higher.
I can swallow pills.
I can provide informed consent.
I agree to practice effective birth control if I can become pregnant.
You may not be able to join if
I have severe kidney disease.
I have more than one big lump of gout.
I have had kidney pain more than once in the past 5 years.
I am pregnant, planning to get pregnant, or breastfeeding.
I am taking too much allopurinol or any dose of febuxostat.
I am allergic to allopurinol.
I would not survive for 2 years due to other health issues.
I have tested positive for a specific genetic marker related to allopurinol.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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/EUL…
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.
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