650
Participants
Start Date
February 22, 2024
Primary Completion Date
September 1, 2028
Study Completion Date
October 31, 2028
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."
Naproxen 250 MG
Naproxen 250 mg p.o. twice daily
Colchicine 0.6 mg
Colchicine 0.6 mg p.o. once daily
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.
Naproxen 500 Mg
dose escalation to 500 mg twice daily for patients experiencing breakthrough flares.
Prednisone 40 mg
For flare glucocorticoids: prednisone taper for 8 days, starting with 40mg (oral) daily.
RECRUITING
NYU Langone, New York
NOT_YET_RECRUITING
West Virginia University (Including Mobile Clinical Trials Unit), Morgantown
NOT_YET_RECRUITING
The University of Alabama at Birmingham, South Birmingham
NOT_YET_RECRUITING
UCLA Health, Santa Monica
RECRUITING
Massachusetts General Hospital, Boston
RECRUITING
Brigham and Women's Hospital (BWH), Boston
NOT_YET_RECRUITING
Boston Medical Center (BMC), Boston
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Massachusetts General Hospital
OTHER