Chronic Gout
Conditions
Keywords
Chronic gouty arthritis, Rasburicase
Brief summary
The study will establish efficacy and safety of rasburicase in chronic gouty arthritis
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.
Interventions
DRUGRasburicase
Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent must be obtained before any assessment is performed, able to understand and comply with the requirements of the study; * Male and female patients 18 to 70 years of age; * Fulfill the ACR/EULAR 2015 gout classification criteria; * Tophi detected by physical examination; * 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
* Pregnant women, lactating women, and men or women who have recently prepared for pregnancy; * Abnormal liver function with AST, ALT, and GGT \>3 times ULN; * Blood WBC\<4.0×10\^9/L, and/or hemoglobin \<90g/L, and/or platelets;\<100×10\^9/L; or other hematologic disorders; * eGFR\<15 ml/min; * Receive following medications: azathioprine, mercaptopurine, cyclosporine, pyrazinamide, ethambutol and sulfamethoxazole * Psychiatric disorders, history of alcoholism, drug or other substance abuse * Immunodeficiency diseases, uncontrolled infection, etc; * Sericosis, glucose-6-phosphate dehydrogenase activity deficiency * Allergy to biological agents and chronic active urticaria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Tophus volume change evaluated by physical examination | 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 | — |
| 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. |
Countries
China
Contacts
Primary ContactQianhua Li, M.D.&Ph.D
Outcome results
None listed