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

Part of paid clinical trials in South Birmingham, Alabama.

Sponsor
Massachusetts General Hospital
Study ID
NCT04875702
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Allopurinol — DRUG
    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 — DRUG
    Naproxen 250 mg p.o. twice daily
  • Colchicine 0.6 mg — DRUG
    Colchicine 0.6 mg p.o. once daily
  • Colchicine 1.2 mg — DRUG
    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 — DRUG
    dose escalation to 500 mg twice daily for patients experiencing breakthrough flares.
  • Prednisone 40 mg — DRUG
    For flare glucocorticoids: prednisone taper for 8 days, starting with 40mg (oral) daily.

Study Details

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.

Key Dates

Start date
Feb 22, 2024
Status verified
Sep 2025
Primary completion
Sep 1, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
650 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Frequency of gout flare [ Time Frame: baseline to two years of follow up ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamSouth BirminghamAlabama35233
Kenneth Saag, MD, MSc
[email protected]
Kevin Riggs, MD, MPH
[email protected]
UCLA HealthSanta MonicaCalifornia90404
John Fitzgerald, MD, PhD
[email protected]
Paul Shekelle, MD,PhD
[email protected]
Boston Medical Center (BMC)BostonMassachusetts02119
Julien J Dedier, MD, MPH
[email protected]
Brigham and Women's Hospital (BWH)BostonMassachusetts02115
Daniel H Solomon, MD, MPH
[email protected]
Jacklyn Stratton
[email protected]
Massachusetts General HospitalBostonMassachusetts02114
Ana D Fernandes, MA
[email protected]
617-643-2140
Hyon K Choi, MD, DrPH (PRINCIPAL_INVESTIGATOR)
NYU LangoneNew YorkNew York10010
Michael Pillinger, MD
[email protected]
David Wei, MD
[email protected]
West Virginia University (Including Mobile Clinical Trials Unit)MorgantownWest Virginia26506
Sally Hodder, MD
[email protected]
304-581-1842
Maggie Childers-Kakos, MS
[email protected]
304-293-1426
Sarah Hansen, MD (SUB_INVESTIGATOR)
Kimberly Houchin, MD (SUB_INVESTIGATOR)
Joanna Bailey, MD (SUB_INVESTIGATOR)
Mathew Weimer, MD (SUB_INVESTIGATOR)

Find similar trials in South Birmingham, AL

By research site
The University of Alabama at Birmingham· South Birmingham, ALUCLA Health· Santa Monica, CABoston Medical Center (BMC)· Boston, MABrigham and Women's Hospital (BWH)· Boston, MAMassachusetts General Hospital· Boston, MANYU Langone· New York, NY

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