About this trial
The goal of this clinical trial is to compare the changes in serum urate levels and symptom recurrence after reducing or suspending urate-lowering agents in well-controlled gout patients (the 'after dishes are clean' state in the Dirty Dish hypothesis)
Researchers will compare three randomized groups: the reducing group takes febuxostat 20 mg once daily for 12 months, the discontinuing group takes a placebo once daily for 6 months, followed by febuxostat 20 mg once daily for the next 6 months, and the maintaining group continues their pre-study urate-lowering agents for 12 months, serving as an observational reference group.
During the 12-month study period, participants will visit every 3 months for laboratory evaluations including serum urate levels, and for checking symptomatic status using questionnaires and diaries. Additionally, musculoskeletal ultrasonography and serum sample collection will be performed at baseline to study predictors for maintaining serum urate levels \<7.0 mg/dL after reducing or suspending urate-lowering therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult gout patients aged ≥19 but <80 years.
Gout patients treated with urate-lowering therapy (either allopurinol or febuxostat monotherapy, or a combination of two agents) for at least the past 5 years.
Patients without palpable or visible tophi on physical examination (evaluated at pre-defined 18 joint sites and the ears).
Patients without acute gouty attack or history of nephrolithiasis in the past 12 months
Disqualifiers
Subjects who continuously require prophylactic low-dose colchicine/NSAIDs.
Subjects already having taken low-dose urate-lowering agents. The low-dose urate-lowering agents are defined as allopurinol ≤200 mg/day or febuxostat ≤20 mg/day. But patients on a combination of low-dose allopurinol and febuxostat are eligible.
Subjects taking medications that could affect serum uric acid levels and uric acid fractional excretion rates, such as benzbromarone, fenofibrate, loop diuretics, thiazide or thiazide-like diuretics, and losartan.
Subjects with a history of hypersensitivity to febuxostat or allopurinol
Trial design
Parallel
Treatments tested in this trial
Febuxostat
DrugThe minimal approved dose of febuxostat is 40 mg/day. We will use 0.5 tablet of febuxostat 40 mg or its placebo.
Treatment groups
Trial outcomes
Primary outcomes
The proportion of patients with serum urate levels <7.0 mg/dL
The proportion of patients who maintain serum urate levels \<7.0 mg/dL at 6 months after taking febuxostat 20 mg once daily or after suspending urate-lowering agents
Secondary outcomes
The proportion of subjects with serum urate <7.0 mg/dL
We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months
Serum urate levels
We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months
Gout Impact Scale (GIS) score using the Korean version
We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months
Patient's overall assessment of gout using a visual analog scale
We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months
Other outcomes
The reliability of the ultrasound scoring system for tophi in gout patients
We will compare the USG scores evaluated by each institution with ones evaluated by an independent review committee.
Sponsors and contacts
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Seoul National University Hospital
Lead sponsor
Seoul National University
Sponsor institution
Gachon University Gil Medical Center
Collaborator
SMG-SNU Boramae Medical Center
Collaborator
Chungnam National University Hospital
Collaborator
Seoul National University Bundang Hospital
Collaborator
Uijeongbu Eulji University Hospital
Collaborator
Ajou University Medical Center
Collaborator