Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT01356602
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2011-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'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': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'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': "Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. 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 pooled data (i.e.,data from all sites) in clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.', 'otherNumAtRisk': 133, 'otherNumAffected': 0, 'seriousNumAtRisk': 133, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.', 'otherNumAtRisk': 133, 'otherNumAffected': 0, 'seriousNumAtRisk': 133, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.', 'otherNumAtRisk': 133, 'otherNumAffected': 0, 'seriousNumAtRisk': 133, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Wound infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Obstructive uropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Aortitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '32', 'spread': '2.08', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '72 hours post dose', 'description': "The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.", 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '72 hours post dose', 'description': "The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.", 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of Pain Intensity on a 0-100mm VAS", 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '14.8', 'spread': '1.72', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 days', 'description': "The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days.", 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of Pain Intensity on a 5-point Likert Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000'}, {'value': '32.6', 'groupId': 'OG001'}, {'value': '23.4', 'groupId': 'OG002'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000'}, {'value': '44.2', 'groupId': 'OG001'}, {'value': '36.7', 'groupId': 'OG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}, {'value': '21.9', 'groupId': 'OG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '14.1', 'groupId': 'OG002'}]}]}, {'title': 'Extreme', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': "A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.", 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With at Least One New Gouty Arthritis Flare After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': "Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.", 'unitOfMeasure': 'Particpants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to the First New Gouty Arthritis Flare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': "Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '25'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '48'}, {'value': '48', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '54'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 days', 'description': "The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.", 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of Gouty Arthritis Flare as Reported by Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '168'}, {'value': '120', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '145'}, {'value': '170', 'groupId': 'OG002', 'lowerLimit': '144', 'upperLimit': '216'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 days', 'description': 'Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': "Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}, {'value': '34.8', 'groupId': 'OG001'}, {'value': '20.4', 'groupId': 'OG002'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000'}, {'value': '36.5', 'groupId': 'OG001'}, {'value': '31.9', 'groupId': 'OG002'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '21.2', 'groupId': 'OG002'}]}]}, {'title': 'Slight', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}, {'value': '14.2', 'groupId': 'OG002'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '12.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': "A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'title': 'Very good', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}, {'value': '33.6', 'groupId': 'OG001'}, {'value': '21.5', 'groupId': 'OG002'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}, {'value': '33.9', 'groupId': 'OG002'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001'}, {'value': '23.1', 'groupId': 'OG002'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '14.0', 'groupId': 'OG002'}]}]}, {'title': 'Very poor', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '7.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': "A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': "Physician's Assessment of Tenderness", 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'title': 'No pain', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '29.8', 'groupId': 'OG002'}]}]}, {'title': 'There is pain', 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000'}, {'value': '52.8', 'groupId': 'OG001'}, {'value': '47.1', 'groupId': 'OG002'}]}]}, {'title': 'There is pain and winces', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}, {'value': '14.0', 'groupId': 'OG002'}]}]}, {'title': 'There is pain, winces and withdraws', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '9.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that "there is pain", 2 = patient states "there is pain and winces" and 3 = patient states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': "Physician's Assessment of Swelling", 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'title': 'No swelling', 'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000'}, {'value': '55.2', 'groupId': 'OG001'}, {'value': '51.2', 'groupId': 'OG002'}]}]}, {'title': 'Palpable', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}, {'value': '25.6', 'groupId': 'OG001'}, {'value': '15.7', 'groupId': 'OG002'}]}]}, {'title': 'Visible', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}, {'value': '24.8', 'groupId': 'OG002'}]}]}, {'title': 'Bulging beyond the joint margins', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.', 'unitOfMeasure': 'Percentage of Partipants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': "Physician's Assessment of Erythema", 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '88.3', 'groupId': 'OG000'}, {'value': '82.9', 'groupId': 'OG001'}, {'value': '68.6', 'groupId': 'OG002'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}, {'value': '31.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': "Physician's Assessment of Range of Motion of the Most Affected Joint", 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '44.8', 'groupId': 'OG001'}, {'value': '35.5', 'groupId': 'OG002'}]}]}, {'title': 'Mildly restricted', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}, {'value': '40.8', 'groupId': 'OG001'}, {'value': '37.2', 'groupId': 'OG002'}]}]}, {'title': 'Moderately restricted', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '12.0', 'groupId': 'OG001'}, {'value': '14.0', 'groupId': 'OG002'}]}]}, {'title': 'Severely restricted', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}, {'value': '12.4', 'groupId': 'OG002'}]}]}, {'title': 'Immobilized', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': "The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Rescue Medication Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}, {'value': '31.8', 'groupId': 'OG001'}, {'value': '45.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Patients used a diary to record the time of intake of rescue medication and the amount taken.', 'unitOfMeasure': 'Percentage of Particpants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to First Rescue Medication Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'spread': '61.87', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '279'}, {'value': '7.5', 'spread': '31.59', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '142'}, {'value': '11', 'spread': '39.06', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '186'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 days', 'description': 'Patients used a diary to record the time of intake of rescue medication and the amount taken.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Amount of Rescue Medication Taken (mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'title': 'Acetaminophen', 'categories': [{'measurements': [{'value': '609.2', 'spread': '1800.06', 'groupId': 'OG000'}, {'value': '1108.3', 'spread': '2821.54', 'groupId': 'OG001'}, {'value': '2323.1', 'spread': '5580.82', 'groupId': 'OG002'}]}]}, {'title': 'Codeine', 'categories': [{'measurements': [{'value': '12.7', 'spread': '55.30', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '124.56', 'groupId': 'OG001'}, {'value': '60.8', 'spread': '191.2', 'groupId': 'OG002'}]}]}, {'title': 'Prednisolone / Prednisone', 'categories': [{'measurements': [{'value': '5.8', 'spread': '23.13', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '25.09', 'groupId': 'OG001'}, {'value': '24.7', 'spread': '53.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'Patients used a diary to record the time of intake of rescue medication and the amount taken.', 'unitOfMeasure': 'milligrams (mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'C-reactive Protein Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'OG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.65', 'groupId': 'OG000', 'lowerLimit': '3.11', 'upperLimit': '4.29'}, {'value': '3.37', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': '3.96'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '4.41', 'upperLimit': '6.13'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '72 hours', 'description': 'A central laboratory was used for analysis of all blood samples collected.', 'unitOfMeasure': 'mg / L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'FG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'FG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '132'}, {'groupId': 'FG002', 'numSubjects': '132'}]}, {'type': 'Safety Set', 'achievements': [{'comment': 'In this arm, 1 patient had only 3 placebo injections and 3 patients also took other active drug.', 'groupId': 'FG000', 'numSubjects': '133'}, {'comment': 'In this arm, 3 patients also took other active drug.', 'groupId': 'FG001', 'numSubjects': '133'}, {'comment': 'In this arm, 3 patients also took other active drug.', 'groupId': 'FG002', 'numSubjects': '133'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '129'}, {'groupId': 'FG002', 'numSubjects': '129'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '117'}, {'groupId': 'FG002', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Administrative Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Number of subjects randomized was 397. Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to a safety set of 399 subjects. Subjects who did not receive study drug were excluded from analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '399', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Canakinumab, Pre-filled Syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'BG001', 'title': 'Canakinumab, Lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'BG002', 'title': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '11.21', 'groupId': 'BG000'}, {'value': '53', 'spread': '11.84', 'groupId': 'BG001'}, {'value': '53.7', 'spread': '11.33', 'groupId': 'BG002'}, {'value': '53.5', 'spread': '11.44', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '364', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 397}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2011-05-16', 'resultsFirstSubmitDate': '2013-09-06', 'studyFirstSubmitQcDate': '2011-05-18', 'lastUpdatePostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-10', 'studyFirstPostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups', 'timeFrame': '72 hours post dose', 'description': "The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method."}], 'secondaryOutcomes': [{'measure': 'Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups', 'timeFrame': '72 hours post dose', 'description': "The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method."}, {'measure': "Patient's Assessment of Pain Intensity on a 0-100mm VAS", 'timeFrame': '14 days', 'description': "The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days."}, {'measure': "Patient's Assessment of Pain Intensity on a 5-point Likert Scale", 'timeFrame': '72 hours', 'description': "A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days."}, {'measure': 'Number of Patients With at Least One New Gouty Arthritis Flare After Baseline', 'timeFrame': '12 weeks', 'description': "Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely."}, {'measure': 'Time to the First New Gouty Arthritis Flare', 'timeFrame': '12 weeks', 'description': "Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated."}, {'measure': 'Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS', 'timeFrame': '14 days', 'description': "The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported."}, {'measure': 'Time to Resolution of Gouty Arthritis Flare as Reported by Patient', 'timeFrame': '14 days', 'description': 'Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.'}, {'measure': "Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale", 'timeFrame': '72 hours', 'description': "A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale."}, {'measure': "Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale", 'timeFrame': '72 hours', 'description': "A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor)."}, {'measure': "Physician's Assessment of Tenderness", 'timeFrame': '72 hours', 'description': 'The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that "there is pain", 2 = patient states "there is pain and winces" and 3 = patient states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.'}, {'measure': "Physician's Assessment of Swelling", 'timeFrame': '72 hours', 'description': 'The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.'}, {'measure': "Physician's Assessment of Erythema", 'timeFrame': '72 hours', 'description': 'The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.'}, {'measure': "Physician's Assessment of Range of Motion of the Most Affected Joint", 'timeFrame': '72 hours', 'description': "The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized)."}, {'measure': 'Proportion of Patients With Rescue Medication Intake', 'timeFrame': '12 weeks', 'description': 'Patients used a diary to record the time of intake of rescue medication and the amount taken.'}, {'measure': 'Time to First Rescue Medication Intake', 'timeFrame': '14 days', 'description': 'Patients used a diary to record the time of intake of rescue medication and the amount taken.'}, {'measure': 'Amount of Rescue Medication Taken (mg)', 'timeFrame': '14 days', 'description': 'Patients used a diary to record the time of intake of rescue medication and the amount taken.'}, {'measure': 'C-reactive Protein Level', 'timeFrame': '72 hours', 'description': 'A central laboratory was used for analysis of all blood samples collected.'}]}, 'conditionsModule': {'keywords': ['Gout', 'arthritis', 'gout flare', 'acute gout', 'gouty', 'rheumatic disease', 'uric acid'], 'conditions': ['Acute Gouty Arthritis']}, 'descriptionModule': {'briefSummary': 'This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 3 or more gout flares within last year\n* Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine\n* Body mass index of less than or equal to 45 kg/m2\n\nExclusion criteria:\n\n* Use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs (such as aspirin), colchicine.\n* Hemodialysis\n* Live vaccine within 3 months before first dose\n* Donation or loss of 400 mL or more within 3 months before first dose\n* Gout brought on by other factors such as chemotherapy, lead, transplant, etc.\n* Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis\n* Any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as HIV, Hepatitis, Tuberculosis and other infections/conditions\n* Significant cardiovascular conditions such as uncontrolled hypertension\n* Significant medical diseases such as uncontrolled diabetes, thyroid disease\n* History of malignancy of any organ system within the past 5 years\n* Women who are pregnant or nursing\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01356602', 'briefTitle': 'Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients', 'orgStudyIdInfo': {'id': 'CACZ885H2361'}, 'secondaryIdInfos': [{'id': '2010-024173-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canakinumab, pre-filled syringes (PFS)', 'description': 'Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.', 'interventionNames': ['Drug: Canakinumab pre-filled syringe', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Canakinumab, lyophilizate (LYO)', 'description': 'The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized powder and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.', 'interventionNames': ['Drug: Canakinumab lyophilized powder', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triamcinolone Acetonide', 'description': 'The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.', 'interventionNames': ['Drug: Triamcinolone Acetonide', 'Drug: Placebo']}], 'interventions': [{'name': 'Canakinumab pre-filled syringe', 'type': 'DRUG', 'description': 'Canakinumab pre-filled syringe', 'armGroupLabels': ['Canakinumab, pre-filled syringes (PFS)']}, {'name': 'Canakinumab lyophilized powder', 'type': 'DRUG', 'description': 'Canakinumab lyophilized powder', 'armGroupLabels': ['Canakinumab, lyophilizate (LYO)']}, {'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'description': 'Triamcinolone Acetonide', 'armGroupLabels': ['Triamcinolone Acetonide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide', 'armGroupLabels': ['Canakinumab, lyophilizate (LYO)', 'Canakinumab, pre-filled syringes (PFS)', 'Triamcinolone Acetonide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207-5710', 'city': 'Anniston', 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