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

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.

Conditions

• Gout

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.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  collaborator NIH

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Hyon K Choi, MD, PhD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-22

Primary Completion

2028-09-01

Completion

2028-10-31

FDA Drug

Yes

Countries

• United States

Study Locations