Chronic GoutPhase 4NCT05312268
Rasburicase Treatment in Chronic Gouty Arthritis
A Phase 4 study testing Rasburicase in people with Chronic Gout, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites in China.
Trial summary
The study will establish efficacy and safety of rasburicase in chronic gouty arthritis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Gout
- What is being tested?
- Rasburicase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesChina
- Study dates
- 15 Jun 2022to 15 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
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- Immunodeficiency diseases, uncontrolled infection, etc;
- Sericosis, glucose-6-phosphate dehydrogenase activity deficiency
- Allergy to biological agents and chronic active urticaria.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Not yet recruiting
Shunde Hospital of Southern Medical University
Foshan, Guangdong
Bin Yang, M.D.&Ph.D, 2075722318000
Bin Liu, M.D.&Ph.D
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Li Qianhua, 862081332572, sumsliqianh@163.com
- Not yet recruiting
Panyu Central Hospital
Guangzhou, Guangdong
Haijun Liu, M.D.&Ph.D, 862034858888, kayjun0753@126.com
Haijun Liu, M.D.&Ph.D
- Not yet recruiting
Shenshan Medical Center
Shanwei, Guangdong, 516600
Yingqian Mo, M.D.&Ph.D, 866603863000, moyingq@mail.sysu.edu.cn
Yingqian Mo, M.D.&Ph.D
About this study
Official title: Efficacy and Safety of Rasburicase in the Treatment of Chronic Gouty Arthritis: A Multicenter Randomized Controlled Study
The study will establish efficacy and safety of rasburicase in chronic gouty arthritis
Read the 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.
- Conditions
- Chronic Gout
- Being tested
- Rasburicase
- Keywords
- Chronic gouty arthritis, Rasburicase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RasburicaseDrug
Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Rasburicase treatment at week 1, 4 and 8 with stable dose oral urate-lowering therapy for 24 weeks. Receives: Drug: Rasburicase |
| Group B | Other | Rasburicase treatment at week 12, 16 and 20 with stable dose oral urate-lowering therapy for 24 weeks. Receives: Drug: Rasburicase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monosodium urate crystal volume change evaluated by dual energy CT
Dual energy CT at baseline, week 12 and week 24
Measured: Baseline to week 12 and week 12 to week 24
Secondary outcomes (13)
Tophus volume change evaluated by physical examination
Measured: Baseline to week 12 and week 12 to week 24
The percentage of patients who have at least one tophi disappeared
Measured: 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
Measured: Baseline to week 12 and week 12 to week 24
Number of gout flare
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to week 12 and week 12 to week 24
Change of Short Form 12 health survey score
Measured: Baseline to week 12 and week 12 to week 24
Change of Tophus Impact Questionnaire (TIQ)-20 score
Measured: Baseline to week 12 and week 12 to week 24
Adverse event
Measured: Baseline to week 12 and week 12 to week 24
Severe adverse event
Measured: Baseline to week 12 and week 12 to week 24
Number of patients who have positive anti-rasburicase antibodies
Measured: Baseline to week 12 and week 12 to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start15 Jun 2022
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic GoutStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qianhua Li, M.D.&Ph.D, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312268
- Sponsor's protocol ID
- 2021-KY-097-001
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rasburicase in the Treatment of Chronic Gouty Arthritis: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05312268
- Acronym / sponsor ID
- 2021-KY-097-001
- Conditions
- Chronic Gout
- Keywords
- Chronic gouty arthritis, Rasburicase
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Drug: RasburicaseRasburicase treatment at week 1, 4 and 8 with stable dose oral urate-lowering therapy for 24 weeks. |
| Group B | Other | Drug: RasburicaseRasburicase treatment at week 12, 16 and 20 with stable dose oral urate-lowering therapy for 24 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RasburicaseRasburicase 1.5 mg/day for 3 consecutive days at scheduled times. | Drug | Group A, Group B |
Primary outcome
Monosodium urate crystal volume change evaluated by dual energy CT
Time frame: Baseline to week 12 and week 12 to week 24
Dual energy CT at baseline, week 12 and week 24
13 secondary outcomes
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
Time frame: Baseline to week 12 and week 12 to week 24
Change of physician global assessment
Time frame: Baseline to week 12 and week 12 to week 24
Change of Visual Analog Scale (VAS) for Pain in gout flare
Time frame: Baseline to week 12 and week 12 to week 24
Change of global functional status
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qianhua Li, M.D.&Ph.D principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rasburicase in people with Chronic Gout, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qianhua Li, M.D.&Ph.D (862081332572, liqianhua@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monosodium urate crystal volume change evaluated by dual energy CT (time frame: Baseline to week 12 and week 12 to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.