The study will establish efficacy and safety of rasburicase in chronic gouty arthritis
The study hypothesis is that the proportion of patients who achieved the primary endpoint after 12 weeks of treatment with rasburicase combined with oral urate-lowering therapy is superior to 12 weeks of treatment with oral urate-lowering therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.
Shunde Hospital of Southern Medical University
Foshan, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGPanyu Central Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGMonosodium urate crystal volume change evaluated by dual energy CT
Dual energy CT at baseline, week 12 and week 24
Time frame: Baseline to week 12 and week 12 to week 24
Tophus volume change evaluated by physical examination
Time frame: Baseline to week 12 and week 12 to week 24
The percentage of patients who have at least one tophi disappeared
Time frame: Baseline to week 12 and week 12 to week 24
The percentage of patients who had achieved serum urate concentrations less than 300 μmol/L (5mg/dl) after 3 months of rasburicase treatment
Time frame: Baseline to week 12 and week 12 to week 24
Number of gout flare
Time frame: Baseline to week 12 and week 12 to week 24
Change of patient global assessment
The patient global assessment is given as a single question, scored from 0-10, with higher numbers representing worse perceived disease activity or overall health.
Time frame: Baseline to week 12 and week 12 to week 24
Change of physician global assessment
The physician global assessment is given as a single question, scored from 0-10, with higher numbers representing worse perceived disease activity or overall health.
Time frame: Baseline to week 12 and week 12 to week 24
Change of Visual Analog Scale (VAS) for Pain in gout flare
Visual Analog for Pain consists of a horizontal line, usually 100mm in length. The left end of the line signifies no pain while the right end signifies the worst possible pain.
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Shenshan Medical Center
Shanwei, Guangdong, China
NOT_YET_RECRUITINGTime frame: Baseline to week 12 and week 12 to week 24
Change of global functional status
The criteria are as follows: class I = able to perform usual activities of daily living (self-care, vocational, and avocational); class II = able to perform usual self-care and vocational activities, but limited in avocational activities; class III = able to perform usual self-care activities but limited in vocational and avocational activities; class IV = limited in ability to perform usual self-care, vocational, and avocational activities.
Time frame: Baseline to week 12 and week 12 to week 24
Change of Short Form 12 health survey score
Time frame: Baseline to week 12 and week 12 to week 24
Change of Tophus Impact Questionnaire (TIQ)-20 score
Time frame: Baseline to week 12 and week 12 to week 24
Adverse event
Time frame: Baseline to week 12 and week 12 to week 24
Severe adverse event
Time frame: Baseline to week 12 and week 12 to week 24
Number of patients who have positive anti-rasburicase antibodies
Time frame: Baseline to week 12 and week 12 to week 24