What this study is
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.
What's being tested
- Allopurinol
Intervention · DRUG
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.
- Naproxen 250 MG
Intervention · DRUG
Naproxen 250 mg p.o. twice daily
- Colchicine 0.6 mg
Intervention · DRUG
Colchicine 0.6 mg p.o. once daily
- Colchicine 1.2 mg
Intervention · DRUG
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.
- Naproxen 500 Mg
Intervention · DRUG
dose escalation to 500 mg twice daily for patients experiencing breakthrough flares.
- Prednisone 40 mg
Intervention · DRUG
For flare glucocorticoids: prednisone taper for 8 days, starting with 40mg (oral) daily.
Study details
- Official title
- Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial
- Sponsor
- Massachusetts General Hospital
- Conditions
- Gout
- Enrolling
- 650 people
- Starts
- 2024-02-22
- Est. completion
- 2028-10-31
- Design
- Double-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 90 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (7)
7 openThe University of Alabama at Birmingham
South Birmingham, Alabama, United States
- Kenneth Saag, MD, MSc · Contactksagg@uabmc.edu
- Kevin Riggs, MD, MPH · Contactkriggs@uab.edu
Not yet recruitingUCLA Health
Santa Monica, California, United States
- John Fitzgerald, MD, PhD · ContactJfitzgerald@mednet.ucla.edu
- Paul Shekelle, MD,PhD · ContactPaul.Shekelle@va.gov
Not yet recruitingMassachusetts General Hospital
Boston, Massachusetts, United States
- Ana D Fernandes, MA · Contact617-643-2140adfernandes@mgh.harvard.edu
- Hyon K Choi, MD, DrPH · Principal investigator
RecruitingBrigham and Women's Hospital (BWH)
Boston, Massachusetts, United States
- Daniel H Solomon, MD, MPH · Contactdsolomon@bwh.harvard.edu
- Jacklyn Stratton · Contactjstratton1@bwh.harvard.edu
RecruitingBoston Medical Center (BMC)
Boston, Massachusetts, United States
- Julien J Dedier, MD, MPH · ContactJulien.Dedier@bmc.org
Not yet recruitingNYU Langone
New York, New York, United States
- Michael Pillinger, MD · ContactMichael.pillinger@nyulangone.org
- David Wei, MD · ContactDavid.Wei@nyulangone.org
RecruitingWest Virginia University (Including Mobile Clinical Trials Unit)
Morgantown, West Virginia, United States
- Sally Hodder, MD · Contact304-581-1842slhodder@hsc.wvu.edu
- Maggie Childers-Kakos, MS · Contact304-293-1426margaret.childers@hsc.wvu.edu
- Sarah Hansen, MD · Sub-investigator
- Kimberly Houchin, MD · Sub-investigator
- Joanna Bailey, MD · Sub-investigator
- Mathew Weimer, MD · Sub-investigator
Not yet recruiting
Study team
Sponsor
Massachusetts General Hospital
Study ID 2021P000517
Principal investigator
Hyon K Choi, MD, PhD
Massachusetts General Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.