Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
⁃ To be eligible to be enrolled in the study, each patient must:
• 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.
• Have experienced at least one gout flare attributed in the previous 12 months.
• Have a baseline inter-critical serum urate (SU) ≥ 6.0 mg/dL (at screening or in the 30 days before screening)
• Be able to swallow pills.
• Agree to practice effective measures of birth control if of reproductive potential.
Locations
United States
Alabama
The University of Alabama at Birmingham
NOT_YET_RECRUITING
South Birmingham
California
UCLA Health
NOT_YET_RECRUITING
Santa Monica
Massachusetts
Boston Medical Center (BMC)
NOT_YET_RECRUITING
Boston
Brigham and Women's Hospital (BWH)
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
New York
NYU Langone
RECRUITING
New York
West Virginia
West Virginia University (Including Mobile Clinical Trials Unit)
NOT_YET_RECRUITING
Morgantown
Contact Information
Primary
Ana D Fernandes, MA
adfernandes@mgh.harvard.edu
617-643-2140
Time Frame
Start Date:2024-02-22
Estimated Completion Date:2028-10-31
Participants
Target number of participants:650
Treatments
Active_comparator: TTT-SU
The participants randomized to the Treat-to-Target-Serum Urate (TTT-SU) group will be counseled about gout, generalized lifestyle and dietary issues and will be provided with a three-month supply of allopurinol as well as a treatment to prophylax against attacks that might occur during the up-titration of urate lowering therapy. Allopurinol dose increases will occur until SU concentrations achieve a target level \< 6.0 mg/dL.
Active_comparator: TTASx
Subjects randomized to the treat-to-avoid-symptoms (TTASx) group will receive the same education as the TTT-SU group. In addition, they will receive anti-inflammatory treatments (naproxen, colchicine, and/or prednisone); enough to treat up to six flares over the ensuing three months.