Rasburicase Treatment in Chronic Gouty Arthritis
Study Details
Study Description
Brief Summary
The study will establish efficacy and safety of rasburicase in chronic gouty arthritis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Group A Rasburicase treatment at week 1, 4 and 8 with stable dose oral urate-lowering therapy for 24 weeks. |
Drug: Rasburicase
Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.
|
| Other: Group B Rasburicase treatment at week 12, 16 and 20 with stable dose oral urate-lowering therapy for 24 weeks. |
Drug: Rasburicase
Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.
|
Outcome Measures
Primary Outcome Measures
- Monosodium urate crystal volume change evaluated by dual energy CT [Baseline to week 12 and week 12 to week 24]
Dual energy CT at baseline, week 12 and week 24
Secondary Outcome Measures
- 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]
- 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 [Baseline to week 12 and week 12 to week 24]
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.
- Change of physician global assessment [Baseline to week 12 and week 12 to week 24]
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.
- Change of Visual Analog Scale (VAS) for Pain in gout flare [Baseline to week 12 and week 12 to week 24]
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.
- Change of global functional status [Baseline to week 12 and week 12 to week 24]
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.
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent must be obtained before any assessment is performed, able to understand and comply with the requirements of the study;
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Male and female patients 18 to 70 years of age;
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Fulfill the ACR/EULAR 2015 gout classification criteria;
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Tophi detected by physical examination;
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Serum urate>300μmol/L (5mg/dl) after one-month maximum dose of urate-lowering therapy (allopurinol 600mg/d or febuxostat 80mg/d in combination with benzbromarone 100mg/d) unless intolerable OR no reduction in size of tophi after serum urate<300μmol/L (5mg/dl) for six month;
Exclusion Criteria:
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Pregnant women, lactating women, and men or women who have recently prepared for pregnancy;
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Abnormal liver function with AST, ALT, and GGT >3 times ULN;
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Blood WBC<4.0×109/L, and/or hemoglobin <90g/L, and/or platelets;<100×109/L; or other hematologic disorders;
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eGFR<15 ml/min;
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Receive following medications: azathioprine, mercaptopurine, cyclosporine, pyrazinamide, ethambutol and sulfamethoxazole
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Psychiatric disorders, history of alcoholism, drug or other substance abuse
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Immunodeficiency diseases, uncontrolled infection, etc;
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Sericosis, glucose-6-phosphate dehydrogenase activity deficiency
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Allergy to biological agents and chronic active urticaria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shunde Hospital of Southern Medical University | Foshan | Guangdong | China | |
| 2 | Panyu Central Hospital | Guangzhou | Guangdong | China | |
| 3 | Shenshan Medical Center | Shanwei | Guangdong | China | 516600 |
Sponsors and Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
- Principal Investigator: Qianhua Li, M.D.&Ph.D, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-KY-097-001