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

PHASE4RecruitingINTERVENTIONAL
Enrollment

650

Participants

Timeline

Start Date

February 22, 2024

Primary Completion Date

September 1, 2028

Study Completion Date

October 31, 2028

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.

Trial Locations (7)

10010

RECRUITING

NYU Langone, New York

26506

NOT_YET_RECRUITING

West Virginia University (Including Mobile Clinical Trials Unit), Morgantown

35233

NOT_YET_RECRUITING

The University of Alabama at Birmingham, South Birmingham

90404

NOT_YET_RECRUITING

UCLA Health, Santa Monica

02114

RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

Brigham and Women's Hospital (BWH), Boston

02119

NOT_YET_RECRUITING

Boston Medical Center (BMC), Boston

All Listed Sponsors
collaborator

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

NIH

lead

Massachusetts General Hospital

OTHER