Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-25 @ 8:04 AM
Study NCT ID:
NCT05312268
Status:
UNKNOWN
Last Update Posted:
2023-05-09
First Post:
2022-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rasburicase Treatment in Chronic Gouty Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C469709', 'term': 'rasburicase'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monosodium urate crystal volume change evaluated by dual energy CT', 'timeFrame': 'Baseline to week 12 and week 12 to week 24', 'description': 'Dual energy CT at baseline, week 12 and week 24'}], 'secondaryOutcomes': [{'measure': 'Tophus volume change evaluated by physical examination', 'timeFrame': 'Baseline to week 12 and week 12 to week 24'}, {'measure': 'The percentage of patients who have at least one tophi disappeared', 'timeFrame': 'Baseline to week 12 and week 12 to week 24'}, {'measure': 'The percentage of patients who had achieved serum urate concentrations less than 300 μmol/L (5mg/dl) after 3 months of rasburicase treatment', 'timeFrame': 'Baseline to week 12 and week 12 to week 24'}, {'measure': 'Number of gout flare', 'timeFrame': 'Baseline to week 12 and week 12 to week 24'}, {'measure': 'Change of patient global assessment', 'timeFrame': 'Baseline to week 12 and week 12 to week 24', '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.'}, {'measure': 'Change of physician global assessment', 'timeFrame': 'Baseline to week 12 and week 12 to week 24', '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.'}, {'measure': 'Change of Visual Analog Scale (VAS) for Pain in gout flare', 'timeFrame': 'Baseline to week 12 and week 12 to week 24', '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.'}, {'measure': 'Change of global functional status', 'timeFrame': 'Baseline to week 12 and week 12 to week 24', '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.'}, {'measure': 'Change of Short Form 12 health survey score', 'timeFrame': 'Baseline to week 12 and week 12 to week 24'}, {'measure': 'Change of Tophus Impact Questionnaire (TIQ)-20 score', 'timeFrame': 'Baseline to week 12 and week 12 to week 24'}, {'measure': 'Adverse event', 'timeFrame': 'Baseline to week 12 and week 12 to week 24'}, {'measure': 'Severe adverse event', 'timeFrame': 'Baseline to week 12 and week 12 to week 24'}, {'measure': 'Number of patients who have positive anti-rasburicase antibodies', 'timeFrame': 'Baseline to week 12 and week 12 to week 24'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic gouty arthritis', 'Rasburicase'], 'conditions': ['Chronic Gout']}, 'descriptionModule': {'briefSummary': 'The study will establish efficacy and safety of rasburicase in chronic gouty arthritis', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent must be obtained before any assessment is performed, able to understand and comply with the requirements of the study;\n* Male and female patients 18 to 70 years of age;\n* Fulfill the ACR/EULAR 2015 gout classification criteria;\n* Tophi detected by physical examination;\n* 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;\n\nExclusion Criteria:\n\n* Pregnant women, lactating women, and men or women who have recently prepared for pregnancy;\n* Abnormal liver function with AST, ALT, and GGT \\>3 times ULN;\n* Blood WBC\\<4.0×10\\^9/L, and/or hemoglobin \\<90g/L, and/or platelets;\\<100×10\\^9/L; or other hematologic disorders;\n* eGFR\\<15 ml/min;\n* Receive following medications: azathioprine, mercaptopurine, cyclosporine, pyrazinamide, ethambutol and sulfamethoxazole\n* Psychiatric disorders, history of alcoholism, drug or other substance abuse\n* Immunodeficiency diseases, uncontrolled infection, etc;\n* Sericosis, glucose-6-phosphate dehydrogenase activity deficiency\n* Allergy to biological agents and chronic active urticaria.'}, 'identificationModule': {'nctId': 'NCT05312268', 'briefTitle': 'Rasburicase Treatment in Chronic Gouty Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Efficacy and Safety of Rasburicase in the Treatment of Chronic Gouty Arthritis: A Multicenter Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2021-KY-097-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A', 'description': 'Rasburicase treatment at week 1, 4 and 8 with stable dose oral urate-lowering therapy for 24 weeks.', 'interventionNames': ['Drug: Rasburicase']}, {'type': 'OTHER', 'label': 'Group B', 'description': 'Rasburicase treatment at week 12, 16 and 20 with stable dose oral urate-lowering therapy for 24 weeks.', 'interventionNames': ['Drug: Rasburicase']}], 'interventions': [{'name': 'Rasburicase', 'type': 'DRUG', 'description': 'Rasburicase 1.5 mg/day for 3 consecutive days at scheduled times.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Foshan', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Yang, M.D.&Ph.D', 'role': 'CONTACT', 'phone': '2075722318000'}, {'name': 'Bin Liu, M.D.&Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shunde Hospital of Southern Medical University', 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Qianhua', 'role': 'CONTACT', 'email': 'sumsliqianh@163.com', 'phone': '862081332572'}], 'facility': 'Sun Yat-sen Memorial Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haijun Liu, M.D.&Ph.D', 'role': 'CONTACT', 'email': 'kayjun0753@126.com', 'phone': '862034858888'}, {'name': 'Haijun Liu, M.D.&Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Panyu Central Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '516600', 'city': 'Shanwei', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingqian Mo, M.D.&Ph.D', 'role': 'CONTACT', 'email': 'moyingq@mail.sysu.edu.cn', 'phone': '866603863000'}, {'name': 'Yingqian Mo, M.D.&Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shenshan Medical Center', 'geoPoint': {'lat': 22.78199, 'lon': 115.3475}}], 'centralContacts': [{'name': 'Qianhua Li, M.D.&Ph.D', 'role': 'CONTACT', 'email': 'liqianhua@mail.sysu.edu.cn', 'phone': '862081332572'}], 'overallOfficials': [{'name': 'Qianhua Li, M.D.&Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}