Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT01593527
Status:
WITHDRAWN
Last Update Posted:
2017-04-20
First Post:
2012-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D015210', 'term': 'Arthritis, Gouty'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541220', 'term': 'canakinumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-19', 'studyFirstSubmitDate': '2012-05-03', 'studyFirstSubmitQcDate': '2012-05-04', 'lastUpdatePostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': 'The time to the first new gout flare', 'timeFrame': '12 Weeks'}, {'measure': 'Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution', 'timeFrame': '12 weeks'}, {'measure': 'Number of patients needing rescue medication use during acute gouty arthritis flare(s)', 'timeFrame': '12 Weeks'}, {'measure': 'Measurement of efficacy using inflammatory markers', 'timeFrame': '12 Weeks'}, {'measure': 'Time to 50% reduction of baseline pain intensity in the most affected joint', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'keywords': ['Frequent flares', 'Frequent attacks', 'gout', 'gouty arthritis', 'Chronic kidney disease', 'renal impairment', 'Anti-interleukin-1β monoclonal antibody', 'anti-inflammatory therapy'], 'conditions': ['Acute Gouty Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months\n* Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4\n* Onset of current acute gouty arthritis flare within 3 days prior to randomization\n\nExclusion criteria:\n\n* Hemodialysis CKD Stage 5 Organ transplantation\n* Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis\n* Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01593527', 'briefTitle': 'Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized Double-blind Active-controlled Trial of Canakinumab Versus Triamcinolone Acetonide on Reducing the Proportion of Patients With Any New Gouty Arthritis Flare(s) in Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'CACZ885H2402'}, 'secondaryIdInfos': [{'id': '2011-001766-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Canakinumab 150 mg s.c.', 'interventionNames': ['Drug: ACZ885']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Triamcinelone acetonide 40 mg i.m.', 'interventionNames': ['Drug: Triamcinelone acetonide']}], 'interventions': [{'name': 'ACZ885', 'type': 'DRUG', 'description': 'Canakinumab 150 mg s.c.', 'armGroupLabels': ['Arm 1']}, {'name': 'Triamcinelone acetonide', 'type': 'DRUG', 'description': 'Triamcinelone acetonide 40 mg i.m.', 'armGroupLabels': ['Arm 2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}