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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

650 Participants

are divided into 2 treatment groups

Group A: TTT-SUActive comparator 3 interventions

Group B: TTASxActive comparator 5 interventions

Trial outcomes

Primary outcomes

Frequency of gout flare

number of gout flares occurring during two years of follow-up between the TTT-SU and TTASx groups

Time frame

baseline to two years of follow up

Secondary outcomes

Quality of life assessment

The Short Form 36 Health Survey Questionnaire (SF-36) questionnaire will be used to assess the health status of study participants by surveying 36 questions in 8 domains of health. A higher score indicates a better health status. For the TRUST study a total physical (score of 10 to 30), functional (a score of 4 to 8) and pain (a score of 2 to 11) will be used as the secondary outcome.

Time frame

baseline to two years of follow up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

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