Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial
Massachusetts General Hospital
Summary
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.
Description
This trial aims to answer a fundamental question in the management of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to determine which is most beneficial for a range of patient-centered gout outcomes, as well as relevant CV-metabolic-renal endpoints. Designing a scientifically valid and pragmatic clinical trial involves numerous tradeoffs in study design, subject eligibility criteria, and outcome measurement. We have come together as primary care physicians and rheumatologists to consider several alternative designs. We first considered the target study popu…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
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 swallo…
Interventions
- DrugAllopurinol
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.
- DrugNaproxen 250 MG
Naproxen 250 mg p.o. twice daily
- DrugColchicine 0.6 mg
Colchicine 0.6 mg p.o. once daily
- DrugColchicine 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.
- DrugNaproxen 500 Mg
dose escalation to 500 mg twice daily for patients experiencing breakthrough flares.
Locations (7)
- The University of Alabama at BirminghamSouth Birmingham, Alabama
- UCLA HealthSanta Monica, California
- Massachusetts General HospitalBoston, Massachusetts
- Brigham and Women's Hospital (BWH)Boston, Massachusetts
- Boston Medical Center (BMC)Boston, Massachusetts
- NYU LangoneNew York, New York