Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-07 @ 3:28 PM
Study NCT ID:
NCT01663506
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2012-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Non-Interventional Study in Patients With Moderate to Severe Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Month 12', 'eventGroups': [{'id': 'EG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 10, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '51.6', 'upperLimit': '89.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000', 'lowerLimit': '47.1', 'upperLimit': '86.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Dose Modification', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}]}]}, {'title': 'Dose Modification + Interruption', 'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000'}]}]}, {'title': 'Dose Modification + Interruption + Irregularity', 'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 12', 'description': 'Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (\\>=) 75 days between two consecutive doses of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Comorbidities at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Iron deficiency anemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Atrial fibrillation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hypothyroidism', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Chronic gastritis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Duodenitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Duodenal ulcer perforation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Dyspepsia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Gastric disorder', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Inguinal hernia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Large intestine polyp', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cholelithiasis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hepatic steatosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Latent tuberculosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pulmonary tuberculosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hyperlipidaemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Spinal osteoarthritis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Osteoarthritis', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Osteopenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Osteoporosis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Rotator cuff syndrome', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Scoliosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Spondyloarthropathy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Spondylolisthesis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Spinal column stenosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Haemangioma of liver', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Ovarian cancer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Radiculopathy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cervical radiculopathy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Gynaecomastia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Chronic obstructive pulmonary disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'No Prior DMARDs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '1 Prior DMARD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '2 Prior DMARDs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '3 Prior DMARDs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '4 Prior DMARDs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '5 Prior DMARDs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Prior Exposure of Biologics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'No Prior Biologics', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '1 Prior Biologic', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '2 Prior Biologics', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score Based on 28-joints Count (DAS28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline (n=22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.35', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.54', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.91', 'spread': '1.59', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.29', 'spread': '1.11', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 3', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 6', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 12', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, 6, and 12', 'description': "DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hr\\]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (\\<=) 2.6 meant clinical remission; DAS28 \\<=3.2 meant low disease activity; DAS28 greater than (\\>) 3.2 to 5.1 implied moderate disease activity; and DAS28 \\>5.1 implied high disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Month 3: Good responders (n=18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: Moderate responders (n=18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: Non-responders (n=18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Good responders (n=16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Moderate responders (n = 16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Non-responders (n=16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: Good responders (n=11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: Moderate responders (n=11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: Non-responders (n=11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, and 12', 'description': 'The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline \\>1.2 with DAS28 \\<= 3.2; moderate responders: decrease from baseline \\>1.2 with DAS28 \\>3.2 or decrease from baseline \\>0.6 to \\<=1.2 with DAS28 \\<=5.1; non-responders: decrease from baseline \\<= 0.6 or decrease from baseline \\>0.6 and \\<=1.2 with DAS28 \\>5.1.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category."}, {'type': 'SECONDARY', 'title': 'Physician Global Assessment (PGA) of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline (n=20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.40', 'spread': '10.08', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.00', 'spread': '18.34', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.80', 'spread': '13.83', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 6', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 12', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Patient Global Assessment (PtGA) of Disease Activity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline (n=22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.68', 'spread': '17.67', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.85', 'spread': '24.22', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.27', 'spread': '21.00', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 6', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 12', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire-Disability Index (HAQ-DI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline (n=20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.80', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'HAQ-DI: participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale (VAS)-Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline (n=22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.18', 'spread': '21.64', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.00', 'spread': '23.25', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.91', 'spread': '22.87', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 6', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 12', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Visual Analog Fatigue Scale (VAFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline (n=6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.00', 'spread': '30.66', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.80', 'spread': '30.38', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.67', 'spread': '6.66', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 12', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale-Morning Stiffness (VAS-MS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline (n=6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.00', 'spread': '12.54', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.60', 'spread': '33.22', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.00', 'spread': '19.80', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Erythrocyte Sedimentation Rate (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline (n=23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.83', 'spread': '27.53', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.81', 'spread': '14.11', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.54', 'spread': '6.77', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 6', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 12', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline (n=23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.16', 'spread': '41.14', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.54', 'spread': '17.54', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.07', 'spread': '7.70', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 6', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 12', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Number of Swollen and Tender Joints Based on 66 and 68 Joints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'SJC66: Baseline (n=7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.29', 'spread': '2.21', 'groupId': 'OG000'}]}]}, {'title': 'TJC68: Baseline (n=7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.86', 'spread': '7.99', 'groupId': 'OG000'}]}]}, {'title': 'SJC66: Month 6 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'Standard deviation was not calculated due to insufficient number of participants analyzed at this time point.', 'groupId': 'OG000'}]}]}, {'title': 'TJC68: Month 6 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'Standard deviation was not calculated due to insufficient number of participants analyzed at this time point.', 'groupId': 'OG000'}]}]}, {'title': 'SJC66: Month 12 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated due to insufficient number of participants analyzed at this time point.', 'groupId': 'OG000'}]}]}, {'title': 'TJC68: Month 12 (n=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated due to insufficient number of participants analyzed at this time point.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.', 'unitOfMeasure': 'joints count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category."}, {'type': 'SECONDARY', 'title': 'Number of Swollen and Tender Joints Based on 28 Joints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'SJC28: Baseline (n=23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.78', 'spread': '4.06', 'groupId': 'OG000'}]}]}, {'title': 'TJC28: Baseline (n=23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.13', 'spread': '7.23', 'groupId': 'OG000'}]}]}, {'title': 'SJC28: Month 6 (n=18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.56', 'spread': '2.79', 'groupId': 'OG000'}]}]}, {'title': 'TJC28: Month 6 (n=18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.11', 'spread': '6.03', 'groupId': 'OG000'}]}]}, {'title': 'SJC28: Month 12 (n=13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.54', 'spread': '2.40', 'groupId': 'OG000'}]}]}, {'title': 'TJC28: Month 12 (n=13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.92', 'spread': '1.85', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'SJC28: Change from Baseline at Month 6', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'TJC28: Change from Baseline at Month 6', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'SJC28: Change from Baseline at Month 12', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'TJC28: Change from Baseline at Month 12', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.', 'unitOfMeasure': 'joints count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category."}, {'type': 'SECONDARY', 'title': 'Simplified Disease Activity Index (SDAI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline (n=20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.99', 'spread': '10.77', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.69', 'spread': '11.60', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.17', 'spread': '6.12', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 6', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 12', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI \\<=3.3 indicates disease remission, \\>3.4 to 11 = low disease activity, \\>11 to 26 = moderate disease activity, and \\>26 = high disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Clinical Disease Activity Index (CDAI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline (n=20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.68', 'spread': '10.21', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.12', 'spread': '11.55', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.77', 'spread': '5.33', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 6', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from Baseline at Month 12', 'statisticalMethod': "Wilcoxon's signed-rank test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI \\<= 2.8 indicates disease remission, \\>2.8 to 10 = low disease activity, \\>10 to 22 = moderate disease activity, and \\>22 = high disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Tocilizumab as Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Study end', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Study end (at Month 12 or at time of study discontinuation)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Study end', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Study end (at Month 12 or at time of study discontinuation)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Receiving Oral Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline (n=23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Month 3, 6, and 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Disease Activity Status Based on DAS28 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline: Remission (n=22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: low disease activity (n=22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: moderate disease activity (n=22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: high disease activity (n=22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: Remission (n=19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: low disease activity (n=19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: moderate disease activity (n=19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: high disease activity (n=19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Remission (n=17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: low disease activity (n=17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: moderate disease activity (n=17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: high disease activity (n=17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: Remission (n=11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: moderate disease activity (n=11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3, 6, and 12', 'description': 'Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score \\<= 2.6; low disease activity: DAS28 \\<=3.2; moderate disease activity: DAS28 \\<=5.1; and high disease activity: DAS28 \\>5.1.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Disease Activity Status Based on SDAI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline: moderate disease activity (n=20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: high disease activity (n=20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: low disease activity (n=16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: moderate disease activity (n=16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: high disease activity (n=16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Remission (n=15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: low disease activity (n=15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: moderate disease activity (n=15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: high disease activity (n=15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: Remission (n=10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: low disease activity (n=10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: moderate disease activity (n=10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3, 6, and 12', 'description': 'Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score \\<= 3.3; low disease activity: SDAI \\<=11.0; moderate disease activity: SDAI \\<=26.0; and high disease activity: SDAI \\>26.0.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Disease Activity Status Based on CDAI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'classes': [{'title': 'Baseline: moderate disease activity (n=20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: high disease activity (n=20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: low disease activity (n=17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: moderate disease activity (n=17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: high disease activity (n=17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Remission (n=15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: low disease activity (n=15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: moderate disease activity (n=15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: high disease activity (n=15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: Remission (n=10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: low disease activity (n=10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Month 12: moderate disease activity (n=10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3, 6, and 12', 'description': 'Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score \\<= 2.8; low disease activity: CDAI \\<=10.0; moderate disease activity: CDAI \\<=22.0; and high disease activity: CDAI \\>22.0.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab (RoActemra/Actemra) treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Consent Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Switched to Subcutaneous Tocilizumab', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tocilizumab', 'description': 'Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '12.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all participants who were enrolled in this study.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2012-08-08', 'resultsFirstSubmitDate': '2015-11-03', 'studyFirstSubmitQcDate': '2012-08-10', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-03', 'studyFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation', 'timeFrame': '6 Months'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation', 'timeFrame': 'Month 12'}, {'measure': 'Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity', 'timeFrame': 'Up to Month 12', 'description': 'Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (\\>=) 75 days between two consecutive doses of study drug.'}, {'measure': 'Number of Participants With Comorbidities at Baseline', 'timeFrame': 'Baseline', 'description': 'Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.'}, {'measure': 'Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)', 'timeFrame': 'Baseline'}, {'measure': 'Number of Participants With Prior Exposure of Biologics', 'timeFrame': 'Baseline'}, {'measure': 'Disease Activity Score Based on 28-joints Count (DAS28)', 'timeFrame': 'Baseline, Month 3, 6, and 12', 'description': "DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hr\\]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (\\<=) 2.6 meant clinical remission; DAS28 \\<=3.2 meant low disease activity; DAS28 greater than (\\>) 3.2 to 5.1 implied moderate disease activity; and DAS28 \\>5.1 implied high disease activity."}, {'measure': 'Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28', 'timeFrame': 'Month 3, 6, and 12', 'description': 'The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline \\>1.2 with DAS28 \\<= 3.2; moderate responders: decrease from baseline \\>1.2 with DAS28 \\>3.2 or decrease from baseline \\>0.6 to \\<=1.2 with DAS28 \\<=5.1; non-responders: decrease from baseline \\<= 0.6 or decrease from baseline \\>0.6 and \\<=1.2 with DAS28 \\>5.1.'}, {'measure': 'Physician Global Assessment (PGA) of Disease Activity', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.'}, {'measure': 'Patient Global Assessment (PtGA) of Disease Activity Score', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.'}, {'measure': 'Health Assessment Questionnaire-Disability Index (HAQ-DI) Score', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'HAQ-DI: participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.'}, {'measure': 'Visual Analog Scale (VAS)-Pain', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.'}, {'measure': 'Visual Analog Fatigue Scale (VAFS)', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.'}, {'measure': 'Visual Analog Scale-Morning Stiffness (VAS-MS)', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.'}, {'measure': 'C-Reactive Protein (CRP)', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.'}, {'measure': 'Number of Swollen and Tender Joints Based on 66 and 68 Joints', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.'}, {'measure': 'Number of Swollen and Tender Joints Based on 28 Joints', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.'}, {'measure': 'Simplified Disease Activity Index (SDAI) Score', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI \\<=3.3 indicates disease remission, \\>3.4 to 11 = low disease activity, \\>11 to 26 = moderate disease activity, and \\>26 = high disease activity.'}, {'measure': 'Clinical Disease Activity Index (CDAI) Score', 'timeFrame': 'Baseline, Month 6, and 12', 'description': 'The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI \\<= 2.8 indicates disease remission, \\>2.8 to 10 = low disease activity, \\>10 to 22 = moderate disease activity, and \\>22 = high disease activity.'}, {'measure': 'Number of Participants Who Received Tocilizumab as Monotherapy', 'timeFrame': 'Baseline, Study end (at Month 12 or at time of study discontinuation)'}, {'measure': 'Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)', 'timeFrame': 'Baseline, Study end (at Month 12 or at time of study discontinuation)'}, {'measure': 'Number of Participants Receiving Oral Corticosteroids', 'timeFrame': 'Baseline, Month 3, 6, and 12'}, {'measure': 'Number of Participants With Disease Activity Status Based on DAS28 Score', 'timeFrame': 'Baseline, Month 3, 6, and 12', 'description': 'Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score \\<= 2.6; low disease activity: DAS28 \\<=3.2; moderate disease activity: DAS28 \\<=5.1; and high disease activity: DAS28 \\>5.1.'}, {'measure': 'Number of Participants With Disease Activity Status Based on SDAI Score', 'timeFrame': 'Baseline, Month 3, 6, and 12', 'description': 'Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score \\<= 3.3; low disease activity: SDAI \\<=11.0; moderate disease activity: SDAI \\<=26.0; and high disease activity: SDAI \\>26.0.'}, {'measure': 'Number of Participants With Disease Activity Status Based on CDAI Score', 'timeFrame': 'Baseline, Month 3, 6, and 12', 'description': 'Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score \\<= 2.8; low disease activity: CDAI \\<=10.0; moderate disease activity: CDAI \\<=22.0; and high disease activity: CDAI \\>22.0.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the local label will be followed for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra (tocilizumab)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria\n* Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 week prior to the enrolment visit\n\nExclusion Criteria:\n\n* Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit\n* Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use\n* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra\n* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT01663506', 'briefTitle': 'A Non-Interventional Study in Patients With Moderate to Severe Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab', 'orgStudyIdInfo': {'id': 'ML28311'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11312', 'city': 'Tallinn', 'country': 'Estonia', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '13419', 'city': 'Tallinn', 'country': 'Estonia', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '51014', 'city': 'Tartu', 'country': 'Estonia', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}