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Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Sponsor: 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.
Official title: Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
650
Start Date
2024-02-22
Completion Date
2028-10-31
Last Updated
2025-09-25
Healthy Volunteers
No
Conditions
Interventions
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.
Naproxen 250 MG
Naproxen 250 mg p.o. twice daily
Colchicine 0.6 mg
Colchicine 0.6 mg p.o. once daily
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.
Naproxen 500 Mg
dose escalation to 500 mg twice daily for patients experiencing breakthrough flares.
Prednisone 40 mg
For flare glucocorticoids: prednisone taper for 8 days, starting with 40mg (oral) daily.
Locations (7)
The University of Alabama at Birmingham
South Birmingham, Alabama, United States
UCLA Health
Santa Monica, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital (BWH)
Boston, Massachusetts, United States
Boston Medical Center (BMC)
Boston, Massachusetts, United States
NYU Langone
New York, New York, United States
West Virginia University (Including Mobile Clinical Trials Unit)
Morgantown, West Virginia, United States