Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-26 @ 11:16 PM
Study NCT ID:
NCT01007435
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2009-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, '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': 'Adverse events were reported from Baseline through Week 52.', 'description': 'Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo to Tocilizumab + Methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.', 'otherNumAtRisk': 282, 'otherNumAffected': 177, 'seriousNumAtRisk': 282, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.', 'otherNumAtRisk': 289, 'otherNumAffected': 182, 'seriousNumAtRisk': 289, 'seriousNumAffected': 29}, {'id': 'EG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.', 'otherNumAtRisk': 290, 'otherNumAffected': 201, 'seriousNumAtRisk': 290, 'seriousNumAffected': 31}, {'id': 'EG003', 'title': 'Tocilizumab 8 mg/kg + Placebo to Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.', 'otherNumAtRisk': 292, 'otherNumAffected': 163, 'seriousNumAtRisk': 292, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 55}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lyme disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pneumococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Endometrial cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Metastatic bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Ovarian germ cell teratoma benign', 'stats': [{'groupId': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Epididymal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Neurosensory hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Oteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 290, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 292, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '292', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Tocilizumab + Methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG003', 'title': 'Tocilizumab 8 mg/kg + Placebo to Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '19.1'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '26.6', 'upperLimit': '37.3'}, {'value': '44.8', 'groupId': 'OG002', 'lowerLimit': '39.1', 'upperLimit': '50.6'}, {'value': '38.7', 'groupId': 'OG003', 'lowerLimit': '33.1', 'upperLimit': '44.3'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.77', 'ciLowerLimit': '3.19', 'ciUpperLimit': '7.14', 'pValueComment': 'A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.', 'estimateComment': 'Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to "non-responder".', 'groupDescription': 'The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + methotrexate treatment groups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The stratification factors, region and serologic status, were included in the model.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.70', 'ciLowerLimit': '2.47', 'ciUpperLimit': '5.55', 'pValueComment': 'A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.', 'estimateComment': 'Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to "non-responder".', 'groupDescription': 'The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + placebo to methotrexate treatment groups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The stratification factors, region and serologic status, were included in the model.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.72', 'ciLowerLimit': '1.80', 'ciUpperLimit': '4.11', 'pValueComment': 'A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons. This comparison came after the break in statistical hierarchy.', 'estimateComment': 'Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to "non-responder".', 'groupDescription': 'The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 4 mg/kg + methotrexate treatment groups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The stratification factors, region and serologic status, were included in the model.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "A participant has a DAS28 remission response if their DAS28 \\< 2.6. The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \\[symptom-free and no arthritis symptoms\\], right end = maximum disease activity \\[maximum arthritis disease activity\\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '292', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Tocilizumab + Methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG003', 'title': 'Tocilizumab 8 mg/kg + Placebo to Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000'}, {'value': '34.0', 'groupId': 'OG001'}, {'value': '49.0', 'groupId': 'OG002'}, {'value': '39.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '292', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Tocilizumab + Methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG003', 'title': 'Tocilizumab 8 mg/kg + Placebo to Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.'}], 'classes': [{'title': 'Week 24: ACR 20', 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000'}, {'value': '73.6', 'groupId': 'OG001'}, {'value': '74.5', 'groupId': 'OG002'}, {'value': '70.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: ACR 50', 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000'}, {'value': '47.9', 'groupId': 'OG001'}, {'value': '56.9', 'groupId': 'OG002'}, {'value': '47.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: ACR 70', 'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000'}, {'value': '34.7', 'groupId': 'OG001'}, {'value': '38.6', 'groupId': 'OG002'}, {'value': '30.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: ACR 20', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '62.8', 'groupId': 'OG001'}, {'value': '67.2', 'groupId': 'OG002'}, {'value': '63.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: ACR 50', 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000'}, {'value': '52.4', 'groupId': 'OG001'}, {'value': '55.9', 'groupId': 'OG002'}, {'value': '49.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: ACR 70', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '37.2', 'groupId': 'OG001'}, {'value': '43.1', 'groupId': 'OG002'}, {'value': '36.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Weeks 24 and 52', 'description': 'Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" \\[symptom-free and no arthritis symptoms\\] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}, {'value': '275', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Tocilizumab + Methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG003', 'title': 'Tocilizumab 8 mg/kg + Placebo to Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'spread': '4.297', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '2.929', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '2.090', 'groupId': 'OG002'}, {'value': '0.26', 'spread': '1.876', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52', 'description': 'The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint, including subluxation, is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Sharp Erosion Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}, {'value': '275', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Tocilizumab + Methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG003', 'title': 'Tocilizumab 8 mg/kg + Placebo to Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '2.556', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '1.686', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '1.736', 'groupId': 'OG002'}, {'value': '0.15', 'spread': '1.544', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sharp Joint Space Narrowing Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}, {'value': '275', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Tocilizumab + Methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG003', 'title': 'Tocilizumab 8 mg/kg + Placebo to Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'spread': '2.362', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '1.645', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.751', 'groupId': 'OG002'}, {'value': '0.11', 'spread': '1.046', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Major Clinical Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '292', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Tocilizumab + Methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG003', 'title': 'Tocilizumab 8 mg/kg + Placebo to Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 52', 'description': 'A major clinical response is defined as an ACR70 response that is maintained for 6 consecutive months (24 weeks) for any 24-week period between Week 2 and Week 52.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '292', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Tocilizumab + Methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG003', 'title': 'Tocilizumab 8 mg/kg + Placebo to Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.'}], 'classes': [{'title': 'Week 24 (n=246, 255, 250, 265)', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.718', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '0.736', 'groupId': 'OG001'}, {'value': '-0.91', 'spread': '0.695', 'groupId': 'OG002'}, {'value': '-0.82', 'spread': '0.739', 'groupId': 'OG003'}]}]}, {'title': 'Week 52 (n=214, 227, 228, 230)', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.800', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.795', 'groupId': 'OG001'}, {'value': '-0.97', 'spread': '0.700', 'groupId': 'OG002'}, {'value': '-0.87', 'spread': '0.776', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 24 and 52', 'description': 'The Stanford HAQ-DI is a patient completed questionnaire specific for rheumatoid arthritis. The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '292', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Tocilizumab + Methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'OG003', 'title': 'Tocilizumab 8 mg/kg + Placebo to Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.'}], 'classes': [{'title': 'Week 24 (n=237, 247, 246, 255)', 'categories': [{'measurements': [{'value': '9.35', 'spread': '9.763', 'groupId': 'OG000'}, {'value': '11.33', 'spread': '9.282', 'groupId': 'OG001'}, {'value': '12.13', 'spread': '9.263', 'groupId': 'OG002'}, {'value': '10.75', 'spread': '10.055', 'groupId': 'OG003'}]}]}, {'title': 'Week 52 (n=204, 225, 221, 224)', 'categories': [{'measurements': [{'value': '10.72', 'spread': '10.389', 'groupId': 'OG000'}, {'value': '12.27', 'spread': '10.509', 'groupId': 'OG001'}, {'value': '13.52', 'spread': '9.848', 'groupId': 'OG002'}, {'value': '11.73', 'spread': '10.691', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Weeks 24 and 52', 'description': 'The SF-36 Health Survey (Version 2) is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo to Tocilizumab + Methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'FG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'FG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'FG003', 'title': 'Tocilizumab 8 mg/kg + Placebo to Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '290'}, {'groupId': 'FG002', 'numSubjects': '291'}, {'groupId': 'FG003', 'numSubjects': '292'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '231'}, {'groupId': 'FG002', 'numSubjects': '227'}, {'groupId': 'FG003', 'numSubjects': '236'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '47'}, {'groupId': 'FG003', 'numSubjects': '31'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Insufficient Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Violation of Selection Criteria at Entry', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Refused Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Failure to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Five of 1162 randomized patients (2 placebo to tocilizumab + methotrexate, 2 tocilizumab 4 mg/kg + methotrexate, 1 tocilizumab 8 mg/kg + methotrexate) did not receive any study treatment and were excluded from all analysis populations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}, {'value': '292', 'groupId': 'BG003'}, {'value': '1157', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo to Tocilizumab + Methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'BG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'BG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.'}, {'id': 'BG003', 'title': 'Tocilizumab 8 mg/kg + Placebo to Methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.6', 'spread': '13.10', 'groupId': 'BG000'}, {'value': '51.2', 'spread': '13.84', 'groupId': 'BG001'}, {'value': '49.5', 'spread': '13.70', 'groupId': 'BG002'}, {'value': '49.9', 'spread': '13.22', 'groupId': 'BG003'}, {'value': '50.1', 'spread': '13.47', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}, {'value': '904', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '253', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics were based on the intent-to-treat (ITT) population. Five of 1162 randomized patients (2 placebo + methotrexate, 2 tocilizumab 4 mg/kg + methotrexate, 1 tocilizumab 8 mg/kg + methotrexate) did not receive any study treatment and were excluded from all analysis populations. The ITT population therefore included 1157 patients.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2014-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2009-11-03', 'resultsFirstSubmitDate': '2013-05-23', 'studyFirstSubmitQcDate': '2009-11-03', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-05-23', 'studyFirstPostDateStruct': {'date': '2009-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24', 'timeFrame': 'Week 24', 'description': "A participant has a DAS28 remission response if their DAS28 \\< 2.6. The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \\[symptom-free and no arthritis symptoms\\], right end = maximum disease activity \\[maximum arthritis disease activity\\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52', 'timeFrame': 'Week 52'}, {'measure': 'Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52', 'timeFrame': 'Baseline to Weeks 24 and 52', 'description': 'Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" \\[symptom-free and no arthritis symptoms\\] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.'}, {'measure': 'Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52', 'timeFrame': 'Baseline to Week 52', 'description': 'The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint, including subluxation, is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.'}, {'measure': 'Change From Baseline in Modified Sharp Erosion Score at Week 52', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Change From Baseline in Sharp Joint Space Narrowing Score at Week 52', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Percentage of Participants With a Major Clinical Response at Week 52', 'timeFrame': 'Baseline to Week 52', 'description': 'A major clinical response is defined as an ACR70 response that is maintained for 6 consecutive months (24 weeks) for any 24-week period between Week 2 and Week 52.'}, {'measure': 'Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52', 'timeFrame': 'Baseline to Weeks 24 and 52', 'description': 'The Stanford HAQ-DI is a patient completed questionnaire specific for rheumatoid arthritis. The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.'}, {'measure': 'Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52', 'timeFrame': 'Baseline to Weeks 24 and 52', 'description': 'The SF-36 Health Survey (Version 2) is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '28389552', 'type': 'DERIVED', 'citation': 'Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Blanco R, Kadva A, Dimonaco S. Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial. Ann Rheum Dis. 2017 Jul;76(7):1279-1284. doi: 10.1136/annrheumdis-2016-210561. Epub 2017 Apr 7.'}, {'pmid': '26511996', 'type': 'DERIVED', 'citation': 'Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Kelman A, Dimonaco S, Mitchell N. Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial. Ann Rheum Dis. 2016 Jun;75(6):1081-91. doi: 10.1136/annrheumdis-2015-207628. Epub 2015 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ≥ 18 years of age.\n* Rheumatoid arthritis of ≤ 2 years duration.\n* Disease Activity Score 28 (DAS28) \\> 3.2.\n* Swollen joint count (SJC) ≥ 4 of 66 joints, tender joint count (TJC) ≥ 6 of 68 joints.\n* Rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) positive (if RF and anti-CCP negative \\> 1 erosion required at screening).\n* Erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ 10 mg/L at screening.\n\nExclusion Criteria:\n\n* Previous treatment with tocilizumab.\n* Previous treatment with methotrexate or biologic agent.\n* Rheumatic autoimmune disease other than rheumatoid arthritis (RA).\n* History of or current inflammatory joint disease other than RA.\n* Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in RA.'}, 'identificationModule': {'nctId': 'NCT01007435', 'briefTitle': 'A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'WA19926'}, 'secondaryIdInfos': [{'id': '2009-012759-12'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(A) Tocilizumab 8 mg/kg + placebo to methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.', 'interventionNames': ['Drug: Tocilizumab', 'Drug: Placebo to methotrexate']}, {'type': 'EXPERIMENTAL', 'label': '(B) Tocilizumab 8 mg/kg + methotrexate', 'description': 'Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.', 'interventionNames': ['Drug: Tocilizumab', 'Drug: Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': '(C) Tocilizumab 4 mg/kg + methotrexate', 'description': 'Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.', 'interventionNames': ['Drug: Tocilizumab', 'Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(D) Placebo to tocilizumab + methotrexate', 'description': 'Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.', 'interventionNames': ['Drug: Placebo to tocilizumab', 'Drug: Methotrexate']}], 'interventions': [{'name': 'Tocilizumab', 'type': 'DRUG', 'otherNames': ['RoActemra', 'Actemra'], 'description': 'Tocilizumab was supplied in vials.', 'armGroupLabels': ['(A) Tocilizumab 8 mg/kg + placebo to methotrexate', '(B) Tocilizumab 8 mg/kg + methotrexate', '(C) Tocilizumab 4 mg/kg + methotrexate']}, {'name': 'Placebo to tocilizumab', 'type': 'DRUG', 'description': 'Placebo to tocilizumab was supplied in vials.', 'armGroupLabels': ['(D) Placebo to tocilizumab + methotrexate']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Initially, patients received methotrexate 7.5 mg (3, 2.5 mg tablets) orally once a week. If a patient had swollen or tender joints, the dose was increased to 15 mg and 20 mg weekly, at the Week 4 and Week 8 visits, respectively.', 'armGroupLabels': ['(B) Tocilizumab 8 mg/kg + methotrexate', '(C) Tocilizumab 4 mg/kg + methotrexate', '(D) Placebo to tocilizumab + methotrexate']}, {'name': 'Placebo to methotrexate', 'type': 'DRUG', 'description': 'Patients received placebo to methotrexate orally once a week.', 'armGroupLabels': ['(A) Tocilizumab 8 mg/kg + placebo to methotrexate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group; Llc, Central', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Rheumatology Associates of North Alabama', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '35406', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clnical & Translational Reseach Center for Alabama, PC', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '85208', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arthrocare, Arthritis Care and Research, P.C.', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sun Valley Arthritis Center', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '92646', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Talbert Medical Group', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Uni of California - San Diego; 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