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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | Rasburicase treatment at week 1, 4 and 8 with stable dose oral urate-lowering therapy for 24 weeks. |
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| Group B | Other | Rasburicase treatment at week 12, 16 and 20 with stable dose oral urate-lowering therapy for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasburicase | Drug | Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times. |
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| Measure | Description | Time Frame |
|---|---|---|
| Monosodium urate crystal volume change evaluated by dual energy CT | Dual energy CT at baseline, week 12 and week 24 | Baseline to week 12 and week 12 to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Tophus volume change evaluated by physical examination | Baseline to week 12 and week 12 to week 24 | |
| The percentage of patients who have at least one tophi disappeared | Baseline to week 12 and week 12 to week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qianhua Li, M.D.&Ph.D | Contact | 862081332572 | liqianhua@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qianhua Li, M.D.&Ph.D | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shunde Hospital of Southern Medical University | Not yet recruiting | Foshan | Guangdong | China |
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| ID | Term |
|---|---|
| C469709 | rasburicase |
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| The percentage of patients who had achieved serum urate concentrations less than 300 μmol/L (5mg/dl) after 3 months of rasburicase treatment | Baseline to week 12 and week 12 to week 24 |
| Number of gout flare | 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. | 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. | 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. | 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. | Baseline to week 12 and week 12 to week 24 |
| Change of Short Form 12 health survey score | Baseline to week 12 and week 12 to week 24 |
| Change of Tophus Impact Questionnaire (TIQ)-20 score | Baseline to week 12 and week 12 to week 24 |
| Adverse event | Baseline to week 12 and week 12 to week 24 |
| Severe adverse event | Baseline to week 12 and week 12 to week 24 |
| Number of patients who have positive anti-rasburicase antibodies | Baseline to week 12 and week 12 to week 24 |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| Panyu Central Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
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| Shenshan Medical Center | Not yet recruiting | Shanwei | Guangdong | 516600 | China |
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