Back to resultsRasburicase Treatment in Chronic Gouty Arthritis
Primary Purpose
Chronic Gout
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Rasburicase
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Gout focused on measuring Chronic gouty arthritis, Rasburicase
Eligibility Criteria
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.
Sites / Locations
- Shunde Hospital of Southern Medical University
- Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityRecruiting
- Panyu Central Hospital
- Shenshan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A
Group B
Arm Description
Rasburicase treatment at week 1, 4 and 8 with stable dose oral urate-lowering therapy for 24 weeks.
Rasburicase treatment at week 12, 16 and 20 with stable dose oral urate-lowering therapy for 24 weeks.
Outcomes
Primary Outcome Measures
Monosodium urate crystal volume change evaluated by dual energy CT
Dual energy CT at baseline, week 12 and week 24
Secondary Outcome Measures
Tophus volume change evaluated by physical examination
The percentage of patients who have at least one tophi disappeared
The percentage of patients who had achieved serum urate concentrations less than 300 μmol/L (5mg/dl) after 3 months of rasburicase treatment
Number of gout flare
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.
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.
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.
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.
Change of Short Form 12 health survey score
Change of Tophus Impact Questionnaire (TIQ)-20 score
Adverse event
Severe adverse event
Number of patients who have positive anti-rasburicase antibodies
Full Information
NCT ID
NCT05312268
First Posted
March 16, 2022
Last Updated
May 8, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT05312268
Brief Title
Rasburicase Treatment in Chronic Gouty Arthritis
Official Title
Efficacy and Safety of Rasburicase in the Treatment of Chronic Gouty Arthritis: A Multicenter Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Gout
Keywords
Chronic gouty arthritis, Rasburicase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Other
Arm Description
Rasburicase treatment at week 1, 4 and 8 with stable dose oral urate-lowering therapy for 24 weeks.
Arm Title
Group B
Arm Type
Other
Arm Description
Rasburicase treatment at week 12, 16 and 20 with stable dose oral urate-lowering therapy for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Rasburicase
Intervention Description
Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.
Primary Outcome Measure Information:
Title
Monosodium urate crystal volume change evaluated by dual energy CT
Description
Dual energy CT at baseline, week 12 and week 24
Time Frame
Baseline to week 12 and week 12 to week 24
Secondary Outcome Measure Information:
Title
Tophus volume change evaluated by physical examination
Time Frame
Baseline to week 12 and week 12 to week 24
Title
The percentage of patients who have at least one tophi disappeared
Time Frame
Baseline to week 12 and week 12 to week 24
Title
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
Title
Number of gout flare
Time Frame
Baseline to week 12 and week 12 to week 24
Title
Change of patient global assessment
Description
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
Title
Change of physician global assessment
Description
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
Title
Change of Visual Analog Scale (VAS) for Pain in gout flare
Description
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.
Time Frame
Baseline to week 12 and week 12 to week 24
Title
Change of global functional status
Description
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
Title
Change of Short Form 12 health survey score
Time Frame
Baseline to week 12 and week 12 to week 24
Title
Change of Tophus Impact Questionnaire (TIQ)-20 score
Time Frame
Baseline to week 12 and week 12 to week 24
Title
Adverse event
Time Frame
Baseline to week 12 and week 12 to week 24
Title
Severe adverse event
Time Frame
Baseline to week 12 and week 12 to week 24
Title
Number of patients who have positive anti-rasburicase antibodies
Time Frame
Baseline to week 12 and week 12 to week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qianhua Li, M.D.&Ph.D
Phone
862081332572
Email
liqianhua@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qianhua Li, M.D.&Ph.D
Organizational Affiliation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shunde Hospital of Southern Medical University
City
Foshan
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Yang, M.D.&Ph.D
Phone
2075722318000
First Name & Middle Initial & Last Name & Degree
Bin Liu, M.D.&Ph.D
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Qianhua
Phone
862081332572
Email
sumsliqianh@163.com
Facility Name
Panyu Central Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haijun Liu, M.D.&Ph.D
Phone
862034858888
Email
kayjun0753@126.com
First Name & Middle Initial & Last Name & Degree
Haijun Liu, M.D.&Ph.D
Facility Name
Shenshan Medical Center
City
Shanwei
State/Province
Guangdong
ZIP/Postal Code
516600
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingqian Mo, M.D.&Ph.D
Phone
866603863000
Email
moyingq@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yingqian Mo, M.D.&Ph.D
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Rasburicase Treatment in Chronic Gouty Arthritis
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