Health Trials

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

ConditionGout
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Provide signed written or electronic informed consent.

Be between 18 and 90 years old.

Be in a participating primary care practice with at least one visit in the previous 36 months.

Be diagnosed with gout by the 2015 ACR/EULAR criteria, with 8 or more points on the 2015 ACR/EULAR criteria scoring algorithm.

Disqualifiers

Diagnosis of CKD Stage 3B or worse (eGFR < 45 mL/min/ 1.73 m2) at screening

More than one subcutaneous tophus on clinical examination at screening

Two or more episodes of renal colic in the past 5 years

Unable to provide informed consent.

Trial design

Treatments tested in this trial

  • Allopurinol
  • Naproxen 250 MG
  • Colchicine 0.6 mg
  • Colchicine 1.2 mg
  • Naproxen 500 Mg
  • Prednisone 40 mg

Treatment groups

650 Participants
are divided into 2 treatment groups

Locations

7
The University of Alabama at Birmingham35233, South BirminghamAlabama, United States
UCLA Health90404, Santa MonicaCalifornia, United States
Boston Medical Center (BMC)02119, BostonMassachusetts, United States
Brigham and Women's Hospital (BWH)02115, BostonMassachusetts, United States

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov