Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:48 PM
Study NCT ID:
NCT00798369
Status:
COMPLETED
Last Update Posted:
2012-04-10
First Post:
2008-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Finland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541220', 'term': 'canakinumab'}, {'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': "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': {'timeFrame': 'End of study (8 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Canakinumab 10 mg', 'description': 'Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.', 'otherNumAtRisk': 28, 'otherNumAffected': 2, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Canakinumab 25 mg', 'description': 'Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.', 'otherNumAtRisk': 29, 'otherNumAffected': 7, 'seriousNumAtRisk': 29, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Canakinumab 50 mg', 'description': 'Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.', 'otherNumAtRisk': 29, 'otherNumAffected': 5, 'seriousNumAtRisk': 29, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Canakinumab 90 mg', 'description': 'Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.', 'otherNumAtRisk': 29, 'otherNumAffected': 8, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Canakinumab 150 mg', 'description': 'Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.', 'otherNumAtRisk': 28, 'otherNumAffected': 5, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Triamcinolone Acetonide 40 mg', 'description': 'Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.', 'otherNumAtRisk': 57, 'otherNumAffected': 8, 'seriousNumAtRisk': 57, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab 10 mg', 'description': 'Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG001', 'title': 'Canakinumab 25 mg', 'description': 'Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG002', 'title': 'Canakinumab 50 mg', 'description': 'Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG003', 'title': 'Canakinumab 90 mg', 'description': 'Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG004', 'title': 'Canakinumab 150 mg', 'description': 'Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG005', 'title': 'Triamcinolone Acetonide 40 mg', 'description': 'Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.'}], 'classes': [{'title': '72 hrs post-dose (n= 28, 28, 26, 28, 27, 53)', 'categories': [{'measurements': [{'value': '-48.6', 'spread': '4.36', 'groupId': 'OG000'}, {'value': '-46.6', 'spread': '4.39', 'groupId': 'OG001'}, {'value': '-48.6', 'spread': '4.56', 'groupId': 'OG002'}, {'value': '-52.7', 'spread': '4.35', 'groupId': 'OG003'}, {'value': '-62.5', 'spread': '4.58', 'groupId': 'OG004'}, {'value': '-43.3', 'spread': '3.16', 'groupId': 'OG005'}]}]}, {'title': '7 days post-dose (n= 26, 28, 27, 27, 26, 51)', 'categories': [{'measurements': [{'value': '-57.6', 'spread': '4.06', 'groupId': 'OG000'}, {'value': '-53.9', 'spread': '3.93', 'groupId': 'OG001'}, {'value': '-63.4', 'spread': '4.00', 'groupId': 'OG002'}, {'value': '-61.2', 'spread': '3.96', 'groupId': 'OG003'}, {'value': '-66.4', 'spread': '4.19', 'groupId': 'OG004'}, {'value': '-56.0', 'spread': '2.88', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline,at 72 hrs post-dose and 7 days post-dose', 'description': 'The change in pain intensity from baseline to 72 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain. Analysis of Covariance (ANCOVA) with treatment group, VAS at baseline and Body mass Index (BMI) at baseline as covariates. Change from baseline = (post-baseline measurement - baseline).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set consisting of all participants with data for baseline and the given time point for each arm/group. Assessments up to Day 8, with 1 missing pain intensity value had it imputed. LOCF method was applied to impute post-dose measurements. Missing baseline values were replaced by the median baseline assessment'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab 10 mg', 'description': 'Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG001', 'title': 'Canakinumab 25 mg', 'description': 'Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG002', 'title': 'Canakinumab 50 mg', 'description': 'Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG003', 'title': 'Canakinumab 90 mg', 'description': 'Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG004', 'title': 'Canakinumab 150 mg', 'description': 'Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG005', 'title': 'Triamcinolone Acetonide 40 mg', 'description': 'Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 72 hours post-baseline', 'description': 'Participants scored their global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Slight and Poor.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab 10 mg', 'description': 'Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG001', 'title': 'Canakinumab 25 mg', 'description': 'Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG002', 'title': 'Canakinumab 50 mg', 'description': 'Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG003', 'title': 'Canakinumab 90 mg', 'description': 'Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG004', 'title': 'Canakinumab 150 mg', 'description': 'Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG005', 'title': 'Triamcinolone Acetonide 40 mg', 'description': 'Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '2.9'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '2.0'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '3.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, within 7 days after randomization', 'description': 'The median time in days to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab 10 mg', 'description': 'Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG001', 'title': 'Canakinumab 25 mg', 'description': 'Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG002', 'title': 'Canakinumab 50 mg', 'description': 'Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG003', 'title': 'Canakinumab 90 mg', 'description': 'Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG004', 'title': 'Canakinumab 150 mg', 'description': 'Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG005', 'title': 'Triamcinolone Acetonide 40 mg', 'description': 'Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.'}], 'classes': [{'title': '72 hrs post-dose (n= 27, 28, 26, 28, 25, 53)', 'categories': [{'measurements': [{'value': '16.7', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '3.34', 'groupId': 'OG001'}, {'value': '11.7', 'spread': '3.49', 'groupId': 'OG002'}, {'value': '13.4', 'spread': '3.34', 'groupId': 'OG003'}, {'value': '9.2', 'spread': '3.53', 'groupId': 'OG004'}, {'value': '13.4', 'spread': '2.43', 'groupId': 'OG005'}]}]}, {'title': '7 days post-dose (n= 28, 29, 28, 28, 27, 55)', 'categories': [{'measurements': [{'value': '8.0', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '3.23', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '3.31', 'groupId': 'OG002'}, {'value': '6.3', 'spread': '3.29', 'groupId': 'OG003'}, {'value': '3.7', 'spread': '3.36', 'groupId': 'OG004'}, {'value': '13.7', 'spread': '2.35', 'groupId': 'OG005'}]}]}, {'title': '4 week post-dose (n= 27, 28, 27, 28, 27, 55)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '3.08', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '3.14', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '3.08', 'groupId': 'OG003'}, {'value': '4.8', 'spread': '3.13', 'groupId': 'OG004'}, {'value': '9.2', 'spread': '2.20', 'groupId': 'OG005'}]}]}, {'title': '8 weeks post-dose (n= 26, 28, 27, 28, 27, 54)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.75', 'groupId': 'OG002'}, {'value': '5.2', 'spread': '1.72', 'groupId': 'OG003'}, {'value': '2.9', 'spread': '1.75', 'groupId': 'OG004'}, {'value': '8.6', 'spread': '1.24', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 72 hours and 7 days, 4 and 8 weeks post-dose', 'description': 'High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.\n\nANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab 10 mg', 'description': 'Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG001', 'title': 'Canakinumab 25 mg', 'description': 'Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG002', 'title': 'Canakinumab 50 mg', 'description': 'Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG003', 'title': 'Canakinumab 90 mg', 'description': 'Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG004', 'title': 'Canakinumab 150 mg', 'description': 'Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG005', 'title': 'Triamcinolone Acetonide 40 mg', 'description': 'Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.'}], 'classes': [{'title': '72 hrs post-dose (n= 26, 28, 28, 28, 27, 50)', 'categories': [{'measurements': [{'value': '50.1', 'spread': '20.05', 'groupId': 'OG000'}, {'value': '27.6', 'spread': '19.32', 'groupId': 'OG001'}, {'value': '70.7', 'spread': '19.37', 'groupId': 'OG002'}, {'value': '29.4', 'spread': '19.28', 'groupId': 'OG003'}, {'value': '26.9', 'spread': '19.69', 'groupId': 'OG004'}, {'value': '52.5', 'spread': '14.48', 'groupId': 'OG005'}]}]}, {'title': '7 days post-dose (n= 28, 28, 28, 28, 26, 49)', 'categories': [{'measurements': [{'value': '10.6', 'spread': '10.92', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '10.91', 'groupId': 'OG001'}, {'value': '11.9', 'spread': '10.94', 'groupId': 'OG002'}, {'value': '10.5', 'spread': '10.89', 'groupId': 'OG003'}, {'value': '10.3', 'spread': '11.33', 'groupId': 'OG004'}, {'value': '39.4', 'spread': '8.26', 'groupId': 'OG005'}]}]}, {'title': '4 week post-dose (n= 27, 28, 27, 28, 27, 50)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '3.46', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '3.53', 'groupId': 'OG002'}, {'value': '14.3', 'spread': '3.45', 'groupId': 'OG003'}, {'value': '6.2', 'spread': '3.53', 'groupId': 'OG004'}, {'value': '12.9', 'spread': '2.59', 'groupId': 'OG005'}]}]}, {'title': '8 weeks post-dose (n= 26, 26, 26, 27, 27, 48)', 'categories': [{'measurements': [{'value': '5.5', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '3.64', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '3.64', 'groupId': 'OG002'}, {'value': '8.2', 'spread': '3.56', 'groupId': 'OG003'}, {'value': '4.1', 'spread': '3.57', 'groupId': 'OG004'}, {'value': '18.0', 'spread': '2.68', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at 72 hours and 7 days, 4 and 8 weeks post-dose', 'description': 'Serum amyloid A (SAA) were determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.\n\nANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'PRIMARY', 'title': 'The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linear Model', 'description': 'The linear model was the best-fitting model out of the 4 selected models (Emax, Logistic, Linear in Log-dose, Linear)with lowest Akaike Information Criterion (AIC).'}], 'classes': [{'title': 'Target dose at 24 hrs post-baseline', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '5.94', 'upperLimit': '103.37'}]}]}, {'title': 'Target dose at 48 hrs post-baseline', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '2.87', 'upperLimit': '96.31'}]}]}, {'title': 'Target dose at 72 hrs post-baseline', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'A target dose for canakinumab to be comparable to triamcinolone acetonide 40 mg could not be estimated at 72 hours as it lies below the range of all doses of canakinumab tested in this trial', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 24,48 and 72 hours post-baseline', 'description': 'Mean target dose at 24, 48 and 72 hours. Four models: Emax, Logistic, Linear in log-dose, Linear were selected to describe the potential dose-response curve and hence estimate the target dose of canakinumab using baseline Visual Analog Scale (VAS) and Body Mass Index (BMI) as covariates. Target dose was defined as the dose for which the efficacy is equivalent to the efficacy of triamcinolone acetonide 40 mg and was identified by assessing the dose response relationship with regards to the pain intensity in the target joint measured on a 0- 100 mm VAS (0= no pain and 100= unbearable pain).', 'unitOfMeasure': 'mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Amount of Rescue Medication Taken for Each Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab 10 mg', 'description': 'Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG001', 'title': 'Canakinumab 25 mg', 'description': 'Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG002', 'title': 'Canakinumab 50 mg', 'description': 'Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG003', 'title': 'Canakinumab 90 mg', 'description': 'Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG004', 'title': 'Canakinumab 150 mg', 'description': 'Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'OG005', 'title': 'Triamcinolone Acetonide 40 mg', 'description': 'Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.'}], 'classes': [{'title': 'Acetaminophen', 'categories': [{'measurements': [{'value': '1414.3', 'spread': '2628.58', 'groupId': 'OG000'}, {'value': '1656.9', 'spread': '4437.26', 'groupId': 'OG001'}, {'value': '2178.6', 'spread': '2925.67', 'groupId': 'OG002'}, {'value': '1646.6', 'spread': '3161.20', 'groupId': 'OG003'}, {'value': '607.4', 'spread': '2250.12', 'groupId': 'OG004'}, {'value': '1614.3', 'spread': '2958.51', 'groupId': 'OG005'}]}]}, {'title': 'Codeine', 'categories': [{'measurements': [{'value': '42.9', 'spread': '138.19', 'groupId': 'OG000'}, {'value': '78.6', 'spread': '164.20', 'groupId': 'OG001'}, {'value': '49.3', 'spread': '139.57', 'groupId': 'OG002'}, {'value': '27.9', 'spread': '87.07', 'groupId': 'OG003'}, {'value': '4.4', 'spread': '23.09', 'groupId': 'OG004'}, {'value': '52.0', 'spread': '158.28', 'groupId': 'OG005'}]}]}, {'title': 'Prednisolone/Prednisone', 'categories': [{'measurements': [{'value': '13.4', 'spread': '36.82', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '44.03', 'groupId': 'OG001'}, {'value': '24.1', 'spread': '59.36', 'groupId': 'OG002'}, {'value': '13.1', 'spread': '35.37', 'groupId': 'OG003'}, {'value': '6.2', 'spread': '24.54', 'groupId': 'OG004'}, {'value': '13.3', 'spread': '26.13', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days after study drug administration', 'description': 'Participants who had difficulty in tolerating their pain after the 6-hour post-dose pain assessments and during the first 7 study days were allowed to take a maximum of 30 mg prednisolone (or equivalent dose of prednisone \\[30 mg\\]) orally once a day for a maximum of 5 days. In addition, participants could use 500 mg acetaminophen (paracetamol) and/or 30 mg codeine as needed during the first 7 study days. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/dose or 180 mg/day of codeine was allowed during the first 7 days of the study.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Canakinumab 10 mg', 'description': 'Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'FG001', 'title': 'Canakinumab 25 mg', 'description': 'Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'FG002', 'title': 'Canakinumab 50 mg', 'description': 'Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'FG003', 'title': 'Canakinumab 90 mg', 'description': 'Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'FG004', 'title': 'Canakinumab 150 mg', 'description': 'Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'FG005', 'title': 'Triamcinolone Acetonide 40 mg', 'description': 'Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adminstrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}, {'value': '200', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Canakinumab 10 mg', 'description': 'Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'BG001', 'title': 'Canakinumab 25 mg', 'description': 'Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'BG002', 'title': 'Canakinumab 50 mg', 'description': 'Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'BG003', 'title': 'Canakinumab 90 mg', 'description': 'Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'BG004', 'title': 'Canakinumab 150 mg', 'description': 'Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.'}, {'id': 'BG005', 'title': 'Triamcinolone Acetonide 40 mg', 'description': 'Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '≥18 years - 40 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}]}]}, {'title': '≥ 41 - 64 years', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '135', 'groupId': 'BG006'}]}]}, {'title': '≥ 65 - 74 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}, {'title': '≥ 75 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}]}], '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': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-09', 'studyFirstSubmitDate': '2008-11-25', 'resultsFirstSubmitDate': '2011-01-20', 'studyFirstSubmitQcDate': '2008-11-25', 'lastUpdatePostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-20', 'studyFirstPostDateStruct': {'date': '2008-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)', 'timeFrame': 'at 24,48 and 72 hours post-baseline', 'description': 'Mean target dose at 24, 48 and 72 hours. Four models: Emax, Logistic, Linear in log-dose, Linear were selected to describe the potential dose-response curve and hence estimate the target dose of canakinumab using baseline Visual Analog Scale (VAS) and Body Mass Index (BMI) as covariates. Target dose was defined as the dose for which the efficacy is equivalent to the efficacy of triamcinolone acetonide 40 mg and was identified by assessing the dose response relationship with regards to the pain intensity in the target joint measured on a 0- 100 mm VAS (0= no pain and 100= unbearable pain).'}], 'secondaryOutcomes': [{'measure': 'The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide', 'timeFrame': 'Baseline,at 72 hrs post-dose and 7 days post-dose', 'description': 'The change in pain intensity from baseline to 72 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain. Analysis of Covariance (ANCOVA) with treatment group, VAS at baseline and Body mass Index (BMI) at baseline as covariates. Change from baseline = (post-baseline measurement - baseline).'}, {'measure': "Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment", 'timeFrame': 'at 72 hours post-baseline', 'description': 'Participants scored their global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Slight and Poor.'}, {'measure': 'The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint', 'timeFrame': 'Baseline, within 7 days after randomization', 'description': 'The median time in days to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).'}, {'measure': 'High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group', 'timeFrame': 'at 72 hours and 7 days, 4 and 8 weeks post-dose', 'description': 'High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.\n\nANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates.'}, {'measure': 'Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group', 'timeFrame': 'at 72 hours and 7 days, 4 and 8 weeks post-dose', 'description': 'Serum amyloid A (SAA) were determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.\n\nANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates.'}, {'measure': 'Amount of Rescue Medication Taken for Each Treatment Group', 'timeFrame': '7 days after study drug administration', 'description': 'Participants who had difficulty in tolerating their pain after the 6-hour post-dose pain assessments and during the first 7 study days were allowed to take a maximum of 30 mg prednisolone (or equivalent dose of prednisone \\[30 mg\\]) orally once a day for a maximum of 5 days. In addition, participants could use 500 mg acetaminophen (paracetamol) and/or 30 mg codeine as needed during the first 7 study days. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/dose or 180 mg/day of codeine was allowed during the first 7 days of the study.'}]}, 'conditionsModule': {'keywords': ['Acute flares', 'Gout', 'Anti-interleukin-1β monoclonal antibody', 'Colchicine', 'Triamcinolone acetonide'], 'conditions': ['Acute Gout']}, 'referencesModule': {'references': [{'pmid': '24122883', 'type': 'DERIVED', 'citation': 'Chakraborty A, Van LM, Skerjanec A, Floch D, Klein UR, Krammer G, Sunkara G, Howard D. Pharmacokinetic and pharmacodynamic properties of canakinumab in patients with gouty arthritis. J Clin Pharmacol. 2013 Dec;53(12):1240-51. doi: 10.1002/jcph.162. Epub 2013 Sep 30.'}, {'pmid': '21439048', 'type': 'DERIVED', 'citation': 'Schlesinger N, De Meulemeester M, Pikhlak A, Yucel AE, Richard D, Murphy V, Arulmani U, Sallstig P, So A. Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis by suppressing inflammation: results of a randomized, dose-ranging study. Arthritis Res Ther. 2011 Mar 25;13(2):R53. doi: 10.1186/ar3297.'}, {'pmid': '20533546', 'type': 'DERIVED', 'citation': 'So A, De Meulemeester M, Pikhlak A, Yucel AE, Richard D, Murphy V, Arulmani U, Sallstig P, Schlesinger N. Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: Results of a multicenter, phase II, dose-ranging study. Arthritis Rheum. 2010 Oct;62(10):3064-76. doi: 10.1002/art.27600.'}]}, 'descriptionModule': {'briefSummary': 'This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the corticosteroid triamcinolone acetonide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of at least 1 gout flare prior to the Screening Visit\n* Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout.\n* Presence of acute gout flare for no longer than 5 days.\n* Baseline pain intensity \\> or = to 50 mm on the 0-100 mm VAS.\n* Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both.\n\nExclusion Criteria:\n\n* Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.\n* Presence of severe renal function impairment\n* Contraindication to intramuscular injection\n* Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment\n* Evidence of active pulmonary disease\n* Live vaccinations within 3 months prior to the start of the study\n* Use of forbidden therapy\n\nOther protocol-defined inclusion/exclusion criteria applied'}, 'identificationModule': {'nctId': 'NCT00798369', 'briefTitle': 'Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Adaptive Dose-ranging, Multi-center, Single-blind, Double-dummy, Active-controlled Trial to Determine the Target Dose of Canakinumab (ACZ885) in the Treatment of Acute Flares in Gout Patients Who Are Refractory or Contraindicated to NSAIDs and/or Colchicine', 'orgStudyIdInfo': {'id': 'CACZ885H2255'}, 'secondaryIdInfos': [{'id': 'EudraCT 2008-004666-61'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canakinumab 10 mg', 'description': 'Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.', 'interventionNames': ['Drug: Canakinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Canakinumab 25 mg', 'description': 'Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.', 'interventionNames': ['Drug: Canakinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Canakinumab 50 mg', 'description': 'Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.', 'interventionNames': ['Drug: Canakinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Canakinumab 90 mg', 'description': 'Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.', 'interventionNames': ['Drug: Canakinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Canakinumab 150 mg', 'description': 'Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.', 'interventionNames': ['Drug: Canakinumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triamcinolone acetonide 40 mg', 'description': 'Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.', 'interventionNames': ['Drug: Triamcinolone acetonide']}], 'interventions': [{'name': 'Canakinumab', 'type': 'DRUG', 'description': 'Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.', 'armGroupLabels': ['Canakinumab 10 mg']}, {'name': 'Canakinumab', 'type': 'DRUG', 'description': 'Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.', 'armGroupLabels': ['Canakinumab 25 mg']}, {'name': 'Canakinumab', 'type': 'DRUG', 'description': 'Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.', 'armGroupLabels': ['Canakinumab 50 mg']}, {'name': 'Canakinumab', 'type': 'DRUG', 'description': 'Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.', 'armGroupLabels': ['Canakinumab 90 mg']}, {'name': 'Canakinumab', 'type': 'DRUG', 'description': 'Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.', 'armGroupLabels': ['Canakinumab 150 mg']}, {'name': 'Triamcinolone acetonide', 'type': 'DRUG', 'description': 'Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.', 'armGroupLabels': ['Triamcinolone acetonide 40 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207-5710', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group, LLC', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90620', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'facility': 'Associated Pharmaceutical Research', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Institute for Bone Health', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Arthritis & Osteoporosis Medical Clinic', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91790', 'city': 'West Covina', 'state': 'California', 'country': 'United States', 'facility': 'Center for Clinical Trials of San Gabriel', 'geoPoint': {'lat': 34.06862, 'lon': -117.93895}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa Medical Group, P.A.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33542', 'city': 'Zephyrhills', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Medical Clinic, PA', 'geoPoint': 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