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 groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov