Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-13 @ 1:18 AM
Study NCT ID:
NCT00663169
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2008-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015210', 'term': 'Arthritis, Gouty'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D006073', 'term': 'Gout'}, {'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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541220', 'term': 'canakinumab'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.', 'otherNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': '72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.'}, {'type': 'SECONDARY', 'title': 'Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.'}], 'timeFrame': '72 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the study only recruited 6 subjects this analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.'}], 'timeFrame': '4 months', 'description': 'Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the study recruited only 6 subjects this analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Time to Walk Independently (if Applicable) During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.'}], 'timeFrame': '4 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the study recruited only 6 subjects this analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.'}], 'classes': [{'title': 'Discontinuation from treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'Additional safety information can be found in the Adverse Event section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in C-reactive Protein (CRP) From Baseline at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.23', 'spread': '16.822', 'groupId': 'OG000'}, {'value': '-30.30', 'spread': '51.963', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4', 'description': 'Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-579.980', 'spread': '563.7449', 'groupId': 'OG000'}, {'value': '-260.327', 'spread': '463.8600', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4', 'description': 'Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.'}, {'type': 'SECONDARY', 'title': 'ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Day 0.25', 'categories': [{'measurements': [{'value': '221.5', 'spread': '143.58', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 (n=2)', 'categories': [{'measurements': [{'value': '276.5', 'spread': '26.163', 'groupId': 'OG000'}]}]}, {'title': 'Day 3 (n=1)', 'categories': [{'measurements': [{'value': '92.3', 'spread': 'NA', 'comment': 'Standard deviation not calculated- data available for only 1 participant.', 'groupId': 'OG000'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '136.6', 'spread': '41,532', 'groupId': 'OG000'}]}]}, {'title': 'Day 20', 'categories': [{'measurements': [{'value': '72.37', 'spread': '11.154', 'groupId': 'OG000'}]}]}, {'title': 'Day 34', 'categories': [{'measurements': [{'value': '52.87', 'spread': '13.194', 'groupId': 'OG000'}]}]}, {'title': 'Day 55', 'categories': [{'measurements': [{'value': '31.67', 'spread': '8.4884', 'groupId': 'OG000'}]}]}, {'title': 'Day 119', 'categories': [{'measurements': [{'value': '7.643', 'spread': '4.6151', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119', 'description': 'Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA).', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Using a Visual Analog Scale at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-62.0', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '-65.7', 'spread': '17.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4', 'description': 'Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Took Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.'}, {'id': 'FG001', 'title': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.'}, {'id': 'BG001', 'title': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'spread': '10.97', 'groupId': 'BG000'}, {'value': '46.0', 'spread': '3.46', 'groupId': 'BG001'}, {'value': '46.3', 'spread': '7.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'dispFirstSubmitDate': '2012-05-22', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2008-04-18', 'dispFirstSubmitQcDate': '2012-05-22', 'resultsFirstSubmitDate': '2012-08-30', 'studyFirstSubmitQcDate': '2008-04-21', 'dispFirstPostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-04', 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale', 'timeFrame': '72 hours', 'description': '72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response.'}], 'secondaryOutcomes': [{'measure': 'Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period', 'timeFrame': '72 hours'}, {'measure': 'Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period', 'timeFrame': '4 months', 'description': 'Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.'}, {'measure': 'Time to Walk Independently (if Applicable) During Treatment Period', 'timeFrame': '4 months'}, {'measure': 'Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study', 'timeFrame': '4 months', 'description': 'Additional safety information can be found in the Adverse Event section.'}, {'measure': 'Change in C-reactive Protein (CRP) From Baseline at Month 4', 'timeFrame': 'Baseline, Month 4', 'description': 'Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.'}, {'measure': 'Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4', 'timeFrame': 'Baseline, Month 4', 'description': 'Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.'}, {'measure': 'ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period', 'timeFrame': 'Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119', 'description': 'Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA).'}, {'measure': 'Change From Baseline in Pain Using a Visual Analog Scale at Month 4', 'timeFrame': 'Baseline, Month 4', 'description': 'Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement.'}, {'measure': 'Number of Patients Who Took Rescue Medication', 'timeFrame': '4 months', 'description': 'Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arthritis Gouty', 'ACZ885', 'IL1B protein', 'Pain'], 'conditions': ['Arthritis, Gouty']}, 'descriptionModule': {'briefSummary': 'This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* score over 50 on the 0-100 VAS pain scale\n* acute, confirmed gout flare for no longer than 3 days\n\nExclusion Criteria:\n\n* Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months\n* Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours\n* Pregnant or breastfeeding women\n* Major surgery with high infection risk\n* History of severe allergy to food or drugs\n* History or risk of tuberculosis\n* Active infection\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00663169', 'briefTitle': 'Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout', 'orgStudyIdInfo': {'id': 'CACZ885A2212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canakinumab', 'description': 'Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.', 'interventionNames': ['Biological: canakinumab', 'Other: placebo matching dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone', 'description': 'Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.', 'interventionNames': ['Drug: dexamethasone', 'Other: placebo matching canakinumab']}], 'interventions': [{'name': 'canakinumab', 'type': 'BIOLOGICAL', 'otherNames': ['ACZ885', 'Ilaris®'], 'description': '10 mg/kg intravenous infusion 250 mL over 2 hours.', 'armGroupLabels': ['Canakinumab']}, {'name': 'dexamethasone', 'type': 'DRUG', 'description': '12 mg intravenous infusion 50 mL over 30 minutes.', 'armGroupLabels': ['Dexamethasone']}, {'name': 'placebo matching canakinumab', 'type': 'OTHER', 'description': '5% glucose in water intravenous infusion.', 'armGroupLabels': ['Dexamethasone']}, {'name': 'placebo matching dexamethasone', 'type': 'OTHER', 'description': 'Placebo intravenous infusion.', 'armGroupLabels': ['Canakinumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis investigator site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}