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RECRUITING
NCT04875702
PHASE4

Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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

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.

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