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GoutDrugPhase 4

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 ↗