Viewing Study NCT00106535

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Ignite Creation Date: 2025-12-24 @ 10:37 PM

Ignite Modification Date: 2025-12-28 @ 4:59 AM

Study NCT ID: NCT00106535

Status: COMPLETED

Last Update Posted: 2014-02-06

First Post: 2005-03-25

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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'}]}, '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': 'Day 1 thru the End of the Study (Up to 6.0 years).', 'description': 'Safety population included all participants who received study treatment based on the treatment actually received. The number of participants at risk is the number of participants in each arm with an adverse event recorded while receiving that treatment. Participants may be counted in more than one arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.\n\nTotal Exposure Placebo + MTX = 282.36 patient-years (PY).', 'otherNumAtRisk': 392, 'otherNumAffected': 169, 'seriousNumAtRisk': 392, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'All Tocilizumab 4 mg/kg + Methotrexate', 'description': 'All participants who received tocilizumab (TCZ) 4 mg/kg IV every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly during the study.\n\nTotal exposure TCZ 4mg + MTX = 580.99 PY.', 'otherNumAtRisk': 599, 'otherNumAffected': 303, 'seriousNumAtRisk': 599, 'seriousNumAffected': 58}, {'id': 'EG002', 'title': 'All Tocilizumab 8 mg/kg + Methotrexate', 'description': 'All participants who received tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly during the study.\n\nTotal exposure TCZ 8mg + MTX = 3797.94 PY.', 'otherNumAtRisk': 1054, 'otherNumAffected': 835, 'seriousNumAtRisk': 1054, 'seriousNumAffected': 267}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 256}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 170}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 123}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 141}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 135}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 97}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 100}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 88}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 111}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 69}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 105}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 85}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 103}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 66}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 53}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 82}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 56}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 58}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 73}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 53}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 99}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 55}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 60}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 55}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac myxoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cervix carcinoma stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hiatus hernia', 'stats': 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15.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Scleroderma renal crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary bladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Digital ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Generalised erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ingrowing nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Leukocytoclastic vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Palpable purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Corneal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 599, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1054, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With American College of Rheumatology-ACR20 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000'}, {'value': '50.6', 'groupId': 'OG001'}, {'value': '56.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': "ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat (ITT) population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ACR50 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '25.1', 'groupId': 'OG001'}, {'value': '32.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': "ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \\[either C-reactive protein or Erythrocyte Sedimentation Rate\\].", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ACR70 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '11.0', 'groupId': 'OG001'}, {'value': '12.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline,Week 24', 'description': "ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \\[either C-reactive protein or Erythrocyte Sedimentation Rate\\].", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Swollen Joint Count (66 Joint Count): Mean Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Baseline Swollen Joint Count (SJC)', 'categories': [{'measurements': [{'value': '16.6', 'spread': '9.23', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '9.78', 'groupId': 'OG001'}, {'value': '17.3', 'spread': '9.48', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 24 (n=391,399, 397)', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '10.37', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '9.31', 'groupId': 'OG001'}, {'value': '-9.0', 'spread': '9.76', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': '66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.', 'unitOfMeasure': 'joint count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.'}, {'type': 'SECONDARY', 'title': 'Tender Joint Count (68 Joint Count): Mean Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Baseline Tender Joint Count (TJC)', 'categories': [{'measurements': [{'value': '27.9', 'spread': '14.80', 'groupId': 'OG000'}, {'value': '27.9', 'spread': '14.15', 'groupId': 'OG001'}, {'value': '29.3', 'spread': '15.22', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 24 (n=391,399, 397)', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '14.61', 'groupId': 'OG000'}, {'value': '-12.2', 'spread': '14.94', 'groupId': 'OG001'}, {'value': '-14.2', 'spread': '14.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': '68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68.', 'unitOfMeasure': 'joint count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.'}, {'type': 'SECONDARY', 'title': "Patient's Global Visual Analog Scale (VAS): Mean Change From Baseline at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Baseline Patient Visual Analog Scale (VAS)', 'categories': [{'measurements': [{'value': '63.1', 'spread': '23.36', 'groupId': 'OG000'}, {'value': '61.0', 'spread': '23.25', 'groupId': 'OG001'}, {'value': '62.7', 'spread': '22.49', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 24 (n=213,308,316)', 'categories': [{'measurements': [{'value': '-17.5', 'spread': '26.60', 'groupId': 'OG000'}, {'value': '-25.2', 'spread': '27.09', 'groupId': 'OG001'}, {'value': '-25.2', 'spread': '24.95', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The patient\'s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'millimeters (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': "Physician's Global VAS: Mean Change From Baseline at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': "Baseline Physician's Visual Analog Scale (VAS)", 'categories': [{'measurements': [{'value': '63.1', 'spread': '17.34', 'groupId': 'OG000'}, {'value': '62.3', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '62.7', 'spread': '16.90', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 24 (n=214,307,320)', 'categories': [{'measurements': [{'value': '-29.0', 'spread': '24.35', 'groupId': 'OG000'}, {'value': '-36.1', 'spread': '24.31', 'groupId': 'OG001'}, {'value': '-39.8', 'spread': '21.82', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The physician\'s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': "Patient's Pain VAS: Mean Change From Baseline at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Baseline Patient Pain Visual Analog Scale (VAS)', 'categories': [{'measurements': [{'value': '55.3', 'spread': '22.07', 'groupId': 'OG000'}, {'value': '53.3', 'spread': '21.97', 'groupId': 'OG001'}, {'value': '55.7', 'spread': '22.34', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 24 (n=213,308,317)', 'categories': [{'measurements': [{'value': '-12.5', 'spread': '24.92', 'groupId': 'OG000'}, {'value': '-19.5', 'spread': '25.24', 'groupId': 'OG001'}, {'value': '-21.8', 'spread': '25.93', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The patient assessed their pain on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change indicated improvement.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP): Mean Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Baseline C-Reactive Protein (CRP)', 'categories': [{'measurements': [{'value': '2.235', 'spread': '2.5068', 'groupId': 'OG000'}, {'value': '2.076', 'spread': '2.3892', 'groupId': 'OG001'}, {'value': '2.337', 'spread': '2.6065', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 24 (n=214,308,321)', 'categories': [{'measurements': [{'value': '-0.3560', 'spread': '2.12778', 'groupId': 'OG000'}, {'value': '-0.9558', 'spread': '2.35222', 'groupId': 'OG001'}, {'value': '-2.0699', 'spread': '2.50035', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The serum concentration of C-Reactive Protein (CRP) is measured in mg/dL. A reduction in the level is considered an improvement.', 'unitOfMeasure': 'milligrams/deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing CRP. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Erythrocyte Sedimentation Rate: Mean Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Baseline Erythrocyte Sedimentation Rate (ESR)', 'categories': [{'measurements': [{'value': '46.5', 'spread': '24.69', 'groupId': 'OG000'}, {'value': '45.9', 'spread': '25.12', 'groupId': 'OG001'}, {'value': '46.4', 'spread': '24.8', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 24 (n=211,304,318)', 'categories': [{'measurements': [{'value': '-9.5', 'spread': '24.01', 'groupId': 'OG000'}, {'value': '-21.8', 'spread': '23.71', 'groupId': 'OG001'}, {'value': '-36.8', 'spread': '24.12', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The Erythrocyte Sedimentation Rate (ESR) was measured in mm/hr. A reduction in the level is considered an improvement.', 'unitOfMeasure': 'millimeters/hour (mm/hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing ESR. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Baseline HAQ-DI', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.60', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 24 (n=197,292,301)', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.516', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.531', 'groupId': 'OG001'}, {'value': '-0.51', 'spread': '0.580', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'HAQ-DI is a self-completed patient questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing HAQ-DI. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Modified Total Sharp-Genant Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'spread': '2.962', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '1.451', 'groupId': 'OG001'}, {'value': '0.29', 'spread': '1.282', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Van Elteren's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by region.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': "Van Elteren's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by region.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Radiographs were taken of each hand and foot at Baseline and Week 52 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 (normalized from 98) and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 (normalized from 104) and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing week 52 data. Data collected after withdrawal or on escape therapy is excluded.'}, {'type': 'PRIMARY', 'title': 'Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-58.11', 'spread': '150.839', 'groupId': 'OG000', 'lowerLimit': '-699.8', 'upperLimit': '401.0'}, {'value': '-128.37', 'spread': '165.084', 'groupId': 'OG001', 'lowerLimit': '-1059.6', 'upperLimit': '266.8'}, {'value': '-144.06', 'spread': '173.372', 'groupId': 'OG002', 'lowerLimit': '-895.7', 'upperLimit': '323.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-70.26', 'ciLowerLimit': '-96.96', 'ciUpperLimit': '-43.56', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for region and original treatment group.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-85.95', 'ciLowerLimit': '-112.69', 'ciUpperLimit': '-59.22', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for region and original treatment group.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 52', 'description': 'HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 52 HAQ-DI score, the AUC of the change from baseline was standardized to 52 weeks using the latest timepoint available for calculation of the AUC. The mean was adjusted for region. A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale*week', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing HAQ scores. All assessments were set to missing after a patient received escape therapy.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Modified Total Sharp-Genant Score at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '353', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.96', 'spread': '5.956', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '2.357', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '1.547', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'Radiographs of each hand and foot were taken at Baseline and Week 104 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdrawal or for patients on escape therapy the data is excluded. Missing data was imputed using linear extrapolation.'}, {'type': 'PRIMARY', 'title': 'Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-139.40', 'spread': '365.682', 'groupId': 'OG000', 'lowerLimit': '-1503.9', 'upperLimit': '801.9'}, {'value': '-287.50', 'spread': '383.201', 'groupId': 'OG001', 'lowerLimit': '-2145.6', 'upperLimit': '630.8'}, {'value': '-320.80', 'spread': '385.741', 'groupId': 'OG002', 'lowerLimit': '-1776.6', 'upperLimit': '677.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-148.10', 'ciLowerLimit': '-205.22', 'ciUpperLimit': '-90.98', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for region.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-181.40', 'ciLowerLimit': '-238.60', 'ciUpperLimit': '-124.21', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for region.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 104', 'description': 'HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 2 years by using the AUC of the change from baseline in HAQ-DI score through week 104. Decreases in AUC of change from baseline in HAQ-DI indicated a gr eater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 104 HAQ-DI score, the AUC of the change from baseline was standardized to 104 weeks using the latest timepoint available for calculation of the AUC. A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale*week', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing HAQ scores. For patients who received escape therapy, the HAQ-DI was set to missing from the time they entered escape.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology (ACR20) Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000'}, {'value': '47.9', 'groupId': 'OG001'}, {'value': '55.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': "ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ACR20 Response at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000'}, {'value': '49.1', 'groupId': 'OG001'}, {'value': '54.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 104', 'description': "ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ACR50 Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '30.3', 'groupId': 'OG001'}, {'value': '36.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': "ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ACR50 Response at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '37.6', 'groupId': 'OG001'}, {'value': '38.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 104', 'description': "ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ACR70 Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '16.5', 'groupId': 'OG001'}, {'value': '20.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': "ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ACR70 Response at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}, {'value': '24.3', 'groupId': 'OG001'}, {'value': '22.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 104', 'description': "ACR50 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ACR70 Response Maintained for 6 Consecutive Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '104 Weeks', 'description': "ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Swollen Joint Count at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '397', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '11.07', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '9.95', 'groupId': 'OG001'}, {'value': '-10.2', 'spread': '10.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': '66 joints were assessed at Baseline and Week 52 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Joint count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Count at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '397', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.1', 'spread': '15.53', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '15.74', 'groupId': 'OG001'}, {'value': '-15.6', 'spread': '16.04', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': '68 joints were assessed at Baseline and Week 52 for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Joint count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for missing tender joint data. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Global Assessment of Disease Activity at Week 52", 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.1', 'spread': '26.22', 'groupId': 'OG000'}, {'value': '-27.2', 'spread': '28.83', 'groupId': 'OG001'}, {'value': '-29.8', 'spread': '25.61', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The patient\'s global assessment of disease activity is assessed at Baseline and Week 52 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physicians Global Assessment of Disease Activity at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-35.2', 'spread': '25.13', 'groupId': 'OG000'}, {'value': '-42.2', 'spread': '23.57', 'groupId': 'OG001'}, {'value': '-45.4', 'spread': '22.22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The physician\'s global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing after the patient received escape therapy.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in the Patient's Pain VAS at Week 52", 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '282', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.0', 'spread': '25.10', 'groupId': 'OG000'}, {'value': '-22.9', 'spread': '25.70', 'groupId': 'OG001'}, {'value': '-26.1', 'spread': '25.51', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The patient assessed their pain at Baseline and Week 52 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. Data was set to missing for patients who received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Reactive Protein (CRP) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '282', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3800', 'spread': '2.50681', 'groupId': 'OG000'}, {'value': '-1.0615', 'spread': '2.39897', 'groupId': 'OG001'}, {'value': '-2.2584', 'spread': '2.71950', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 52 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was made for missing data. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.9', 'spread': '24.27', 'groupId': 'OG000'}, {'value': '-25.6', 'spread': '24.68', 'groupId': 'OG001'}, {'value': '-38.5', 'spread': '24.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 52 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. Data was set to missing for patients who received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Swollen Joint Count at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '397', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'spread': '11.65', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '10.76', 'groupId': 'OG001'}, {'value': '-11.3', 'spread': '11.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': '66 joints were assessed at Baseline and Week 104 for swelling and joints were classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Joint count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Count at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '397', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '17.07', 'groupId': 'OG000'}, {'value': '-13.6', 'spread': '16.53', 'groupId': 'OG001'}, {'value': '-17.7', 'spread': '16.73', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': '68 joints were assessed for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Joint count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Global Assessment of Disease Activity at Week 104", 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.2', 'spread': '26.35', 'groupId': 'OG000'}, {'value': '-31.6', 'spread': '27.05', 'groupId': 'OG001'}, {'value': '-33.9', 'spread': '26.60', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'The patient\'s global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physicians Global Assessment of Disease Activity at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.9', 'spread': '21.55', 'groupId': 'OG000'}, {'value': '-49.1', 'spread': '20.33', 'groupId': 'OG001'}, {'value': '-48.7', 'spread': '22.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'The physician\'s global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in the Patient's Pain VAS at Week 104", 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.6', 'spread': '24.44', 'groupId': 'OG000'}, {'value': '-26.6', 'spread': '25.39', 'groupId': 'OG001'}, {'value': '-28.9', 'spread': '25.47', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'The patient assessed their pain at Baseline and Week 104 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Reactive Protein (CRP) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '251', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6346', 'spread': '2.28001', 'groupId': 'OG000'}, {'value': '-1.6863', 'spread': '2.20965', 'groupId': 'OG001'}, {'value': '-2.3068', 'spread': '2.65256', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 104 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.7', 'spread': '22.26', 'groupId': 'OG000'}, {'value': '-35.4', 'spread': '25.07', 'groupId': 'OG001'}, {'value': '-36.9', 'spread': '23.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 104 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'groupId': 'OG000'}, {'value': '59.6', 'groupId': 'OG001'}, {'value': '62.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': 'The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing for patients who received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000'}, {'value': '63.3', 'groupId': 'OG001'}, {'value': '62.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 104', 'description': 'The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).\n\n.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Area Under Curve (AUC) of the ACRn to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '609.11', 'spread': '5551.669', 'groupId': 'OG000'}, {'value': '2791.49', 'spread': '5479.514', 'groupId': 'OG001'}, {'value': '3528.89', 'spread': '5812.582', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Weeks', 'description': "The ACRn is defined as each patient's lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 24. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.", 'unitOfMeasure': 'Score on a scale*week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Area Under Curve (AUC) of the ACRn to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '5551.25', 'spread': '6080.038', 'groupId': 'OG000', 'lowerLimit': '-49420.8', 'upperLimit': '25818.8'}, {'value': '10763.54', 'spread': '7488.703', 'groupId': 'OG001', 'lowerLimit': '-74637.5', 'upperLimit': '33589.0'}, {'value': '12644.01', 'spread': '7248.249', 'groupId': 'OG002', 'lowerLimit': '-13773.8', 'upperLimit': '31246.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5212.28', 'ciLowerLimit': '3139.40', 'ciUpperLimit': '7285.16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for region.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7092.76', 'ciLowerLimit': '5066.16', 'ciUpperLimit': '9119.36', 'pValueComment': 'Adjusted for region.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '52 Weeks', 'description': "The ACRn is defined as each patient's lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 52. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.", 'unitOfMeasure': 'Score on a scale*week', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population(all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Area Under Curve (AUC) of the ACRn Score at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '21094.97', 'spread': '22341.489', 'groupId': 'OG000'}, {'value': '27141.08', 'spread': '24296.659', 'groupId': 'OG001'}, {'value': '30876.59', 'spread': '18177.420', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '104 Weeks', 'description': "The ACRn is defined as each patient's lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 104. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.", 'unitOfMeasure': 'Score on a scale*week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score (DAS28) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}, {'value': '311', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.49', 'spread': '1.257', 'groupId': 'OG000'}, {'value': '-2.45', 'spread': '1.401', 'groupId': 'OG001'}, {'value': '-3.28', 'spread': '1.383', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score (DAS28) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.88', 'spread': '1.319', 'groupId': 'OG000'}, {'value': '-2.97', 'spread': '1.391', 'groupId': 'OG001'}, {'value': '-3.80', 'spread': '1.263', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score (DAS28) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.70', 'spread': '1.416', 'groupId': 'OG000'}, {'value': '-3.82', 'spread': '1.306', 'groupId': 'OG001'}, {'value': '-4.14', 'spread': '1.344', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Good EULAR Response', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '24.6', 'groupId': 'OG001'}, {'value': '40.7', 'groupId': 'OG002'}]}]}, {'title': 'Moderate EULAR Response', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '39.6', 'groupId': 'OG001'}, {'value': '33.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.\n\nEuropean League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline \\< -1.2.\n\nEULAR Moderate response: DAS28 \\>3.2 to ≤ 5.1 or a change from Baseline \\< -0.6 to ≥ -1.2.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Good Response', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '27.6', 'groupId': 'OG001'}, {'value': '44.0', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Response', 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000'}, {'value': '30.3', 'groupId': 'OG001'}, {'value': '24.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.\n\nEuropean League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline \\< -1.2.\n\nEULAR Moderate response: DAS28 \\>3.2 to ≤ 5.1 or a change from Baseline \\< -0.6 to ≥ -1.2.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Good Response', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}, {'value': '39.6', 'groupId': 'OG001'}, {'value': '45.7', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Response', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '15.8', 'groupId': 'OG001'}, {'value': '13.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 104', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.\n\nEuropean League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline \\< -1.2.\n\nEULAR Moderate response: DAS28 \\>3.2 to ≤ 5.1 or a change from Baseline \\< -0.6 to ≥ -1.2.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation was used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28 Remission at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 remission is defined as a DAS28 score \\<2.6.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28 Remission at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '30.5', 'groupId': 'OG001'}, {'value': '48.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control.DAS28 Remission is defined as a DAS28 score \\<2.6.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28 Remission at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '241', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}, {'value': '55.4', 'groupId': 'OG001'}, {'value': '64.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \\<2.6.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}, {'value': '311', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '895.85', 'spread': '179.465', 'groupId': 'OG000'}, {'value': '767.02', 'spread': '208.462', 'groupId': 'OG001'}, {'value': '670.45', 'spread': '193.506', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Weeks', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).", 'unitOfMeasure': 'Score on a scale*week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '1755.25', 'spread': '353.653', 'groupId': 'OG000'}, {'value': '1423.12', 'spread': '415.188', 'groupId': 'OG001'}, {'value': '1235.80', 'spread': '412.134', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).", 'unitOfMeasure': 'Score on a scale*week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '2793.01', 'spread': '675.840', 'groupId': 'OG000'}, {'value': '2426.11', 'spread': '743.882', 'groupId': 'OG001'}, {'value': '2094.71', 'spread': '749.148', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '104 Weeks', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).", 'unitOfMeasure': 'Score on a scale*week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Total Sharp-Genant Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'spread': '1.336', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.843', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.985', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Radiographs were taken of each hand and foot at Baseline and Week 24 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdraw or on escape therapy is excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Total Sharp-Genant Score at Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '353', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.60', 'spread': '4.658', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '1.845', 'groupId': 'OG001'}, {'value': '0.31', 'spread': '1.273', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 80', 'description': 'Radiographs were taken of each hand and foot at Baseline and Week 80 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erosion Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'spread': '0.928', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.563', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.625', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Van Elteren's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by region.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': "Van Elteren's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data was set to missing for patients who withdrew or received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erosion Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '1.892', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.920', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.860', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Van Elteren's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by region.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': "Van Elteren's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by region.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data for this outcome measure. Missing Week 52 data was imputed using Linear extrapolation. Data was set to missing for patients who withdrew or received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erosion Score at Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '353', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '3.101', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '1.101', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '1.060', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 80', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erosion Score at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '353', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.24', 'spread': '3.947', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '1.337', 'groupId': 'OG001'}, {'value': '0.22', 'spread': '1.301', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Joint Space Narrowing Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '0.659', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.416', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.468', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data was set to missing for patients who withdrew or received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Joint Space Narrowing Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'spread': '1.695', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.739', 'groupId': 'OG001'}, {'value': '0.12', 'spread': '0.640', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Joint Space Narrowing Score at Week 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '353', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.59', 'spread': '2.589', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '1.035', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.626', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 80', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Joint Space Narrowing Score at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '353', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'spread': '3.321', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '1.368', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.772', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With no Progression of Erosion at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000'}, {'value': '83.8', 'groupId': 'OG001'}, {'value': '88.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdraw or on escape therapy was excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With no Progression of Erosion at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}, {'value': '82.6', 'groupId': 'OG001'}, {'value': '86.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With no Progression of Erosion at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '353', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000'}, {'value': '78.4', 'groupId': 'OG001'}, {'value': '85.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 104', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With no Progression of Joint Space Narrowing at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.3', 'groupId': 'OG000'}, {'value': '91.4', 'groupId': 'OG001'}, {'value': '91.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score was defined as a change from Baseline of less than or equal to zero.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdrawal or on escape therapy was excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With no Progression of Joint Space Narrowing at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000'}, {'value': '90.6', 'groupId': 'OG001'}, {'value': '90.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With no Progression of Joint Space Narrowing at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '353', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.3', 'groupId': 'OG000'}, {'value': '86.0', 'groupId': 'OG001'}, {'value': '91.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 104', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAQ Disability Index (HAQ-DI) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.570', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.607', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.583', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAQ Disability Index at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.612', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.608', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '0.661', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8). Total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality Life Short Form-36 (SF-36) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '294', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Physical component score', 'categories': [{'measurements': [{'value': '5.54', 'spread': '8.459', 'groupId': 'OG000'}, {'value': '8.15', 'spread': '8.135', 'groupId': 'OG001'}, {'value': '8.46', 'spread': '8.520', 'groupId': 'OG002'}]}]}, {'title': 'Mental component score', 'categories': [{'measurements': [{'value': '3.27', 'spread': '11.092', 'groupId': 'OG000'}, {'value': '4.63', 'spread': '11.702', 'groupId': 'OG001'}, {'value': '5.17', 'spread': '10.869', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. . Data was set to missing for patients who received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SF-36 Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Physical component summary score', 'categories': [{'measurements': [{'value': '5.6', 'spread': '8.42', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '8.29', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '9.13', 'groupId': 'OG002'}]}]}, {'title': 'Mental component summary score', 'categories': [{'measurements': [{'value': '3.7', 'spread': '10.67', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '11.94', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '11.49', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. Data was set to missing for patients who received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SF-36 Score at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Physical component score', 'categories': [{'measurements': [{'value': '8.7', 'spread': '9.53', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '9.50', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '9.66', 'groupId': 'OG002'}]}]}, {'title': 'Mental component score', 'categories': [{'measurements': [{'value': '5.2', 'spread': '10.27', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '11.22', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '11.55', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.32', 'spread': '10.133', 'groupId': 'OG000'}, {'value': '7.14', 'spread': '10.145', 'groupId': 'OG001'}, {'value': '6.91', 'spread': '8.877', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing FACIT-Fatigue scores. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FACIT-F Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.57', 'spread': '10.087', 'groupId': 'OG000'}, {'value': '8.14', 'spread': '10.880', 'groupId': 'OG001'}, {'value': '8.27', 'spread': '9.387', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FACIT-F Score at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.62', 'spread': '9.544', 'groupId': 'OG000'}, {'value': '7.85', 'spread': '10.578', 'groupId': 'OG001'}, {'value': '8.63', 'spread': '9.737', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': "FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Rheumatoid Factor (RF) at Week 24 in Those Patients With Positive RF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.7', 'spread': '273.71', 'groupId': 'OG000'}, {'value': '-79.3', 'spread': '315.06', 'groupId': 'OG001'}, {'value': '-75.6', 'spread': '205.76', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 24 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= \\>15 IU/mL. A lower number change from Baseline indicated a better result.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Rheumatoid Factor (RF) at Week 52 in Those Patients With Positive RF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.5', 'spread': '444.37', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '575.02', 'groupId': 'OG001'}, {'value': '-71.6', 'spread': '213.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 52 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= \\>15 IU/mL. A lower number change from Baseline indicated a better result.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Rheumatoid Factor (RF) at Week 104 in Those Patients With Positive RF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.0', 'spread': '304.46', 'groupId': 'OG000'}, {'value': '-25.1', 'spread': '431.29', 'groupId': 'OG001'}, {'value': '-39.2', 'spread': '253.29', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 104 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= \\>15 IU/mL. A lower number change from Baseline indicated a better result.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of ACR20 by Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}, {'value': '328', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '116.0', 'groupId': 'OG000', 'lowerLimit': '113.0', 'upperLimit': '141.0'}, {'value': '57.0', 'groupId': 'OG001', 'lowerLimit': '57.0', 'upperLimit': '82.0'}, {'value': '57.0', 'groupId': 'OG002', 'lowerLimit': '56.0', 'upperLimit': '57.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': "Time in days until ACR20 response. ACR20 response was defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population \\[N=393,399,398\\] (all randomized participants who received study drug) with ACR20 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of ACR50 by Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Value not calculable due to insufficient events.', 'groupId': 'OG000', 'lowerLimit': '173.0', 'upperLimit': 'NA'}, {'value': '170.0', 'comment': 'Value not calculable due to insufficient events.', 'groupId': 'OG001', 'lowerLimit': '169.0', 'upperLimit': 'NA'}, {'value': '141.0', 'groupId': 'OG002', 'lowerLimit': '139.0', 'upperLimit': '169.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': "Time in days until ACR50 response. ACR50 response was defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population \\[N=393,399,398\\] (all randomized participants who received study drug) with ACR50 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of ACR70 by Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Value not calculable due to insufficient events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Value not calculable due to insufficient events.', 'groupId': 'OG001', 'lowerLimit': '176.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Value not calculable due to insufficient events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': "Time in days until ACR70 response. ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population \\[N=393,399,398\\] (all randomized participants who received study drug) with ACR70 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Withdraw Due to Lack of Sufficient Therapeutic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '104 Weeks', 'description': 'Insufficient therapeutic response (patient not responding to the drug as assessed by the physician) was selected by the investigator as a reason that the patient withdrew from the study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. Data on escape therapy is excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Each Treatment Group Who Receive Escape Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'title': 'Escape 1 Therapy', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Escape 2 Therapy', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '104 Weeks', 'description': 'In Escape 1, participants in the Tocilizumab 4 mg/kg + Methotrexate and Tocilizumab 8 mg/kg + Methotrexate groups received tocilizumab 8 mg/kg as escape therapy. Participants in the Placebo + Methotrexate group received tocilizumab 4 mg/kg as escape therapy.\n\nIn Escape 2, all participants received tocilizumab 8 mg/kg.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Weeks', 'description': 'The percentage of participants, who achieved ACR remission at any study visit up to Week 24. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness \\< 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR \\< 30 mm/hr for a female or 20 mm/hr for a male.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 Weeks', 'description': 'The percentage of participants, who achieved ACR remission at any study visit up to Week 52. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness \\< 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR \\< 30 mm/hr for a female or 20 mm/hr for a male.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '104 Weeks', 'description': 'The percentage of participants who achieved ACR remission at any study visit up to Week 104. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness \\< 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR \\< 30 mm/hr for a female or 20 mm/hr for a male.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Complete Clinical Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 Weeks', 'description': 'Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria \\[defined as five of the following criteria are met for at least two consecutive months: morning stiffness \\< 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR \\< 30 mm/hr for a female or 20 mm/hr for a male\\] and no radiographic progression \\[defined as change from baseline ≤ 0 in the total Sharp-Genant score, erosion score, and JSN score\\]. Patients who achieve a complete clinical response at any time in the study are counted as responders, even if the response is not maintained.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew or where an ACR could not be calculated, were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Complete Clinical Response at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '104 Weeks', 'description': 'Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria \\[defined as five of the following criteria are met for at least two consecutive months: morning stiffness \\< 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR \\< 30 mm/hr for a female or 20 mm/hr for a male\\] and no radiographic progression \\[defined as change from baseline ≤ 0 in the total Sharp-Genant score, erosion score, and JSN score\\].', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew or where an ACR could not be calculated, were set to 'Non Responder'."}, {'type': 'SECONDARY', 'title': 'End of Study: Percentage of Participants With ACR Response at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '473', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'title': 'ACR 20 Response', 'categories': [{'measurements': [{'value': '82.9', 'groupId': 'OG000'}]}]}, {'title': 'ACR 50 Response', 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000'}]}]}, {'title': 'ACR 70 Response', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}]}]}, {'title': 'ACR 90 Response', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 260', 'description': "ACR20/50/70/90 response is defined as a ≥ 20/50/70/90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Baseline and Week 260. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments.'}, {'type': 'SECONDARY', 'title': 'End of Study: Percentage of Participants With DAS28 Remission at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 260', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \\<2.6.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.'}, {'type': 'SECONDARY', 'title': 'End of Study: Percentage of Participants With DAS28 Low Disease Activity (LDA) at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 260', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDA is defined as DAS28 ≤3.2.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.'}, {'type': 'SECONDARY', 'title': 'End of Study: Percentage of Participants With DAS28 European League Against Rheumatism (EULAR) Good or Moderate Response at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'title': 'Good Response', 'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000'}]}]}, {'title': 'Moderate Response', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 260', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. EULAR Good response: DAS28 ≤ 3.2 and a change from Baseline \\< -1.2. EULAR Moderate response: DAS28 \\>3.2 to ≤ 5.1 or a change from Baseline \\< -0.6 to ≥ -1.2.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.'}, {'type': 'SECONDARY', 'title': 'End of Study: Change From Baseline in Swollen Joint Count at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.2', 'spread': '10.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 260', 'description': '66 joints were assessed at Baseline and Week 260 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Joint Count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. Last observation carried forward was used for missing joint counts.'}, {'type': 'SECONDARY', 'title': 'End of Study: Change From Baseline in Tender Joint Count at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.6', 'spread': '14.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 260', 'description': '68 joints were assessed at Baseline and Week 260 for tenderness and joints are classified as tender/not tender for a total possible swollen joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Joint Count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. Last observation carried forward was used for missing joint counts.'}, {'type': 'SECONDARY', 'title': 'End of Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.657', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 260', 'description': 'HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. No imputation was used for missing HAQ score.'}, {'type': 'SECONDARY', 'title': "End of Study: Change From Baseline in the Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) at Week 260", 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.7', 'spread': '27.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 260', 'description': 'The patient\'s global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.'}, {'type': 'SECONDARY', 'title': "End of Study: Change From Baseline in the Physician's Global Assessment of Disease Activity VAS at Week 260", 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.7', 'spread': '21.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 260', 'description': 'The physician\'s global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.'}, {'type': 'SECONDARY', 'title': "End of Study: Change From Baseline in the Patient's Pain VAS at Week 260", 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.2', 'spread': '26.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 260', 'description': 'The patient assessed their pain at Baseline and Week 260 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.'}, {'type': 'SECONDARY', 'title': 'End of Study: Percentage of Participants With Clinical Improvement in the FACIT-Fatigue Score at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '473', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 260', 'description': "FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5 change from Baseline.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available for analysis at Baseline and Week 260.'}, {'type': 'SECONDARY', 'title': 'End of Study: Percentage of Participants With Clinical Relevant Improvement in the SF-36 Score at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'title': 'Mental Components Summary', 'categories': [{'measurements': [{'value': '43.7', 'groupId': 'OG000'}]}]}, {'title': 'Physical Components summary', 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 260', 'description': 'The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. Clinically relevant improvement is defined as a ≥5 change from Baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available for analysis at Baseline and Week 260.'}, {'type': 'SECONDARY', 'title': 'End of Study: Change From Baseline in Total Sharp-Genant Score at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Tocilizumab + Methotrexate', 'description': 'All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.30', 'spread': '6.093', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '4.272', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 260', 'description': 'Radiographs were taken of each hand and foot at Baseline and Week 260 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint).The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score. The results were reported based on the treatment the patient was originally randomized to.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data.'}, {'type': 'SECONDARY', 'title': 'End of Study: Change From Baseline in Erosion Score at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Tocilizumab + Methotrexate', 'description': 'All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.95', 'spread': '3.640', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '2.657', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 260', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot and were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best ) to 142 (worst). A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data.'}, {'type': 'SECONDARY', 'title': 'End of Study: Change From Baseline in Joint Space Narrowing Score at Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Tocilizumab + Methotrexate', 'description': 'All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.35', 'spread': '3.134', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '2.222', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 260', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with \\< 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a \\>70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.'}, {'id': 'FG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab (TCZ) 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with \\< 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a \\>70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension (LTE) period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.'}, {'id': 'FG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with \\< 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a \\>70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.'}, {'id': 'FG003', 'title': 'All Tocilizumab Exposure + MTX', 'description': 'All tocilizumab (TCZ) exposure + methotrexate (MTX) group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either Placebo, Tocilizumab 4 mg/kg or Tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received 8 mg/kg IV every 4 weeks.'}], 'periods': [{'title': '2-year Placebo Controlled Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '394'}, {'groupId': 'FG001', 'numSubjects': '401'}, {'groupId': 'FG002', 'numSubjects': '401'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Intent-to-treat: Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '393'}, {'groupId': 'FG001', 'numSubjects': '399'}, {'groupId': 'FG002', 'numSubjects': '398'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Safety: Actual Treatment Received', 'achievements': [{'groupId': 'FG000', 'numSubjects': '392'}, {'groupId': 'FG001', 'numSubjects': '399'}, {'groupId': 'FG002', 'numSubjects': '399'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Completed Week 24', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '373'}, {'groupId': 'FG002', 'numSubjects': '366'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Completed Week 52', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326'}, {'groupId': 'FG001', 'numSubjects': '342'}, {'groupId': 'FG002', 'numSubjects': '338'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed Week 104 (Year 2). 284 participants randomized to the Placebo arm entered the LTE period.', 'groupId': 'FG000', 'numSubjects': '287'}, {'comment': 'Completed Week 104. 304 participants randomized to the TCZ 4 mg/kg arm entered the LTE period.', 'groupId': 'FG001', 'numSubjects': '309'}, {'comment': 'Completed Week 104. 306 participants randomized to the TCZ 8 mg/kg arm entered the LTE period.', 'groupId': 'FG002', 'numSubjects': '310'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '92'}, {'groupId': 'FG002', 'numSubjects': '91'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Long-term Extension Period (Year 3 to 5)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Entered the Long-term Extension.', 'groupId': 'FG003', 'numSubjects': '894'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Completed the study.', 'groupId': 'FG003', 'numSubjects': '704'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '190'}]}]}], 'preAssignmentDetails': 'This study was divided into two phases: a 2-year core placebo controlled treatment phase and an optional 3-year extension phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'BG000'}, {'value': '399', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}, {'value': '1190', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.'}, {'id': 'BG001', 'title': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'BG002', 'title': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '12.41', 'groupId': 'BG000'}, {'value': '51.4', 'spread': '12.59', 'groupId': 'BG001'}, {'value': '53.4', 'spread': '11.72', 'groupId': 'BG002'}, {'value': '52.0', 'spread': '12.24', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '328', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '989', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline measures are based on the Intent-to-treat population that included all randomized participants who received study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2005-03-25', 'resultsFirstSubmitDate': '2010-02-09', 'studyFirstSubmitQcDate': '2005-03-25', 'lastUpdatePostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-06', 'studyFirstPostDateStruct': {'date': '2005-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With American College of Rheumatology-ACR20 Response', 'timeFrame': 'Baseline, Week 24', 'description': "ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate."}, {'measure': 'Change From Baseline in Modified Total Sharp-Genant Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Radiographs were taken of each hand and foot at Baseline and Week 52 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 (normalized from 98) and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 (normalized from 104) and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.'}, {'measure': 'Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52', 'timeFrame': 'Baseline to Week 52', 'description': 'HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 52 HAQ-DI score, the AUC of the change from baseline was standardized to 52 weeks using the latest timepoint available for calculation of the AUC. The mean was adjusted for region. A negative change from baseline indicated improvement.'}, {'measure': 'Change From Baseline in the Modified Total Sharp-Genant Score at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'Radiographs of each hand and foot were taken at Baseline and Week 104 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.'}, {'measure': 'Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104', 'timeFrame': 'Baseline to Week 104', 'description': 'HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 2 years by using the AUC of the change from baseline in HAQ-DI score through week 104. Decreases in AUC of change from baseline in HAQ-DI indicated a gr eater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 104 HAQ-DI score, the AUC of the change from baseline was standardized to 104 weeks using the latest timepoint available for calculation of the AUC. A negative change from baseline indicated improvement.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With ACR50 Response', 'timeFrame': 'Baseline, Week 24', 'description': "ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \\[either C-reactive protein or Erythrocyte Sedimentation Rate\\]."}, {'measure': 'Percentage of Participants With ACR70 Response', 'timeFrame': 'Baseline,Week 24', 'description': "ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \\[either C-reactive protein or Erythrocyte Sedimentation Rate\\]."}, {'measure': 'Swollen Joint Count (66 Joint Count): Mean Change From Baseline at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': '66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.'}, {'measure': 'Tender Joint Count (68 Joint Count): Mean Change From Baseline at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': '68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68.'}, {'measure': "Patient's Global Visual Analog Scale (VAS): Mean Change From Baseline at Week 24", 'timeFrame': 'Baseline, Week 24', 'description': 'The patient\'s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.'}, {'measure': "Physician's Global VAS: Mean Change From Baseline at Week 24", 'timeFrame': 'Baseline, Week 24', 'description': 'The physician\'s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity).'}, {'measure': "Patient's Pain VAS: Mean Change From Baseline at Week 24", 'timeFrame': 'Baseline and Week 24', 'description': 'The patient assessed their pain on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change indicated improvement.'}, {'measure': 'C-Reactive Protein (CRP): Mean Change From Baseline at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The serum concentration of C-Reactive Protein (CRP) is measured in mg/dL. A reduction in the level is considered an improvement.'}, {'measure': 'Erythrocyte Sedimentation Rate: Mean Change From Baseline at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The Erythrocyte Sedimentation Rate (ESR) was measured in mm/hr. A reduction in the level is considered an improvement.'}, {'measure': 'Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'HAQ-DI is a self-completed patient questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.'}, {'measure': 'Percentage of Participants With American College of Rheumatology (ACR20) Response at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate."}, {'measure': 'Percentage of Participants With ACR20 Response at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': "ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate."}, {'measure': 'Percentage of Participants With ACR50 Response at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate."}, {'measure': 'Percentage of Participants With ACR50 Response at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': "ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate."}, {'measure': 'Percentage of Participants With ACR70 Response at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate."}, {'measure': 'Percentage of Participants With ACR70 Response at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': "ACR50 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate."}, {'measure': 'Percentage of Participants With ACR70 Response Maintained for 6 Consecutive Months', 'timeFrame': '104 Weeks', 'description': "ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate."}, {'measure': 'Change From Baseline in Swollen Joint Count at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': '66 joints were assessed at Baseline and Week 52 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in Tender Joint Count at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': '68 joints were assessed at Baseline and Week 52 for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.'}, {'measure': "Change From Baseline in Patient's Global Assessment of Disease Activity at Week 52", 'timeFrame': 'Baseline, Week 52', 'description': 'The patient\'s global assessment of disease activity is assessed at Baseline and Week 52 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in Physicians Global Assessment of Disease Activity at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The physician\'s global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.'}, {'measure': "Change From Baseline in the Patient's Pain VAS at Week 52", 'timeFrame': 'Baseline, Week 52', 'description': 'The patient assessed their pain at Baseline and Week 52 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in C-Reactive Protein (CRP) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 52 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.'}, {'measure': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 52 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.'}, {'measure': 'Change From Baseline in Swollen Joint Count at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': '66 joints were assessed at Baseline and Week 104 for swelling and joints were classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in Tender Joint Count at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': '68 joints were assessed for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.'}, {'measure': "Change From Baseline in Patient's Global Assessment of Disease Activity at Week 104", 'timeFrame': 'Baseline, Week 104', 'description': 'The patient\'s global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in Physicians Global Assessment of Disease Activity at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'The physician\'s global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.'}, {'measure': "Change From Baseline in the Patient's Pain VAS at Week 104", 'timeFrame': 'Baseline, Week 104', 'description': 'The patient assessed their pain at Baseline and Week 104 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in C-Reactive Protein (CRP) at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 104 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.'}, {'measure': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 104 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.'}, {'measure': 'Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).'}, {'measure': 'Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).\n\n.'}, {'measure': 'Area Under Curve (AUC) of the ACRn to Week 24', 'timeFrame': '24 Weeks', 'description': "The ACRn is defined as each patient's lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 24. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better."}, {'measure': 'Area Under Curve (AUC) of the ACRn to Week 52', 'timeFrame': '52 Weeks', 'description': "The ACRn is defined as each patient's lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 52. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better."}, {'measure': 'Area Under Curve (AUC) of the ACRn Score at Week 104', 'timeFrame': '104 Weeks', 'description': "The ACRn is defined as each patient's lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 104. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better."}, {'measure': 'Change From Baseline in Disease Activity Score (DAS28) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement."}, {'measure': 'Change From Baseline in Disease Activity Score (DAS28) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement."}, {'measure': 'Change From Baseline in Disease Activity Score (DAS28) at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement."}, {'measure': 'Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.\n\nEuropean League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline \\< -1.2.\n\nEULAR Moderate response: DAS28 \\>3.2 to ≤ 5.1 or a change from Baseline \\< -0.6 to ≥ -1.2."}, {'measure': 'Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.\n\nEuropean League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline \\< -1.2.\n\nEULAR Moderate response: DAS28 \\>3.2 to ≤ 5.1 or a change from Baseline \\< -0.6 to ≥ -1.2."}, {'measure': 'Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.\n\nEuropean League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline \\< -1.2.\n\nEULAR Moderate response: DAS28 \\>3.2 to ≤ 5.1 or a change from Baseline \\< -0.6 to ≥ -1.2."}, {'measure': 'Percentage of Participants With DAS28 Remission at Week 24', 'timeFrame': 'Week 24', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 remission is defined as a DAS28 score \\<2.6."}, {'measure': 'Percentage of Participants With DAS28 Remission at Week 52', 'timeFrame': 'Week 52', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control.DAS28 Remission is defined as a DAS28 score \\<2.6."}, {'measure': 'Percentage of Participants With DAS28 Remission at Week 104', 'timeFrame': 'Week 104', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \\<2.6."}, {'measure': 'Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 24', 'timeFrame': '24 Weeks', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity)."}, {'measure': 'Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 52', 'timeFrame': '52 Weeks', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity)."}, {'measure': 'Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 104', 'timeFrame': '104 Weeks', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity)."}, {'measure': 'Change From Baseline in Modified Total Sharp-Genant Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Radiographs were taken of each hand and foot at Baseline and Week 24 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.'}, {'measure': 'Change From Baseline in Modified Total Sharp-Genant Score at Week 80', 'timeFrame': 'Baseline, Week 80', 'description': 'Radiographs were taken of each hand and foot at Baseline and Week 80 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.'}, {'measure': 'Change From Baseline in Erosion Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.'}, {'measure': 'Change From Baseline in Erosion Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.'}, {'measure': 'Change From Baseline in Erosion Score at Week 80', 'timeFrame': 'Baseline, Week 80', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.'}, {'measure': 'Change From Baseline in Erosion Score at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.'}, {'measure': 'Change From Baseline in Joint Space Narrowing Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower change from Baseline indicated a better score.'}, {'measure': 'Change From Baseline in Joint Space Narrowing Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.'}, {'measure': 'Change From Baseline in Joint Space Narrowing Score at Week 80', 'timeFrame': 'Baseline, Week 80', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.'}, {'measure': 'Change From Baseline in Joint Space Narrowing Score at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.'}, {'measure': 'Percentage of Participants With no Progression of Erosion at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.'}, {'measure': 'Percentage of Participants With no Progression of Erosion at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.'}, {'measure': 'Percentage of Participants With no Progression of Erosion at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.'}, {'measure': 'Percentage of Participants With no Progression of Joint Space Narrowing at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score was defined as a change from Baseline of less than or equal to zero.'}, {'measure': 'Percentage of Participants With no Progression of Joint Space Narrowing at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.'}, {'measure': 'Percentage of Participants With no Progression of Joint Space Narrowing at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.'}, {'measure': 'Change From Baseline in HAQ Disability Index (HAQ-DI) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.'}, {'measure': 'Change From Baseline in HAQ Disability Index at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8). Total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in Quality Life Short Form-36 (SF-36) Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in SF-36 Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in SF-36 Score at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': "FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status."}, {'measure': 'Change From Baseline in FACIT-F Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status."}, {'measure': 'Change From Baseline in FACIT-F Score at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': "FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status."}, {'measure': 'Change From Baseline in Rheumatoid Factor (RF) at Week 24 in Those Patients With Positive RF', 'timeFrame': 'Baseline, Week 24', 'description': 'Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 24 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= \\>15 IU/mL. A lower number change from Baseline indicated a better result.'}, {'measure': 'Change From Baseline in Rheumatoid Factor (RF) at Week 52 in Those Patients With Positive RF', 'timeFrame': 'Baseline, Week 52', 'description': 'Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 52 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= \\>15 IU/mL. A lower number change from Baseline indicated a better result.'}, {'measure': 'Change From Baseline in Rheumatoid Factor (RF) at Week 104 in Those Patients With Positive RF', 'timeFrame': 'Baseline, Week 104', 'description': 'Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 104 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= \\>15 IU/mL. A lower number change from Baseline indicated a better result.'}, {'measure': 'Time to Onset of ACR20 by Treatment Group', 'timeFrame': '6 months', 'description': "Time in days until ACR20 response. ACR20 response was defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate."}, {'measure': 'Time to Onset of ACR50 by Treatment Group', 'timeFrame': '6 months', 'description': "Time in days until ACR50 response. ACR50 response was defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate."}, {'measure': 'Time to Onset of ACR70 by Treatment Group', 'timeFrame': '6 months', 'description': "Time in days until ACR70 response. ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate."}, {'measure': 'Percentage of Participants Who Withdraw Due to Lack of Sufficient Therapeutic Response', 'timeFrame': '104 Weeks', 'description': 'Insufficient therapeutic response (patient not responding to the drug as assessed by the physician) was selected by the investigator as a reason that the patient withdrew from the study.'}, {'measure': 'Percentage of Participants in Each Treatment Group Who Receive Escape Therapy', 'timeFrame': '104 Weeks', 'description': 'In Escape 1, participants in the Tocilizumab 4 mg/kg + Methotrexate and Tocilizumab 8 mg/kg + Methotrexate groups received tocilizumab 8 mg/kg as escape therapy. Participants in the Placebo + Methotrexate group received tocilizumab 4 mg/kg as escape therapy.\n\nIn Escape 2, all participants received tocilizumab 8 mg/kg.'}, {'measure': 'Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 24', 'timeFrame': '24 Weeks', 'description': 'The percentage of participants, who achieved ACR remission at any study visit up to Week 24. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness \\< 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR \\< 30 mm/hr for a female or 20 mm/hr for a male.'}, {'measure': 'Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 52', 'timeFrame': '52 Weeks', 'description': 'The percentage of participants, who achieved ACR remission at any study visit up to Week 52. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness \\< 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR \\< 30 mm/hr for a female or 20 mm/hr for a male.'}, {'measure': 'Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 104', 'timeFrame': '104 Weeks', 'description': 'The percentage of participants who achieved ACR remission at any study visit up to Week 104. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness \\< 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR \\< 30 mm/hr for a female or 20 mm/hr for a male.'}, {'measure': 'Percentage of Participants Who Achieved Complete Clinical Response at Week 52', 'timeFrame': '52 Weeks', 'description': 'Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria \\[defined as five of the following criteria are met for at least two consecutive months: morning stiffness \\< 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR \\< 30 mm/hr for a female or 20 mm/hr for a male\\] and no radiographic progression \\[defined as change from baseline ≤ 0 in the total Sharp-Genant score, erosion score, and JSN score\\]. Patients who achieve a complete clinical response at any time in the study are counted as responders, even if the response is not maintained.'}, {'measure': 'Percentage of Participants Who Achieved Complete Clinical Response at Week 104', 'timeFrame': '104 Weeks', 'description': 'Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria \\[defined as five of the following criteria are met for at least two consecutive months: morning stiffness \\< 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR \\< 30 mm/hr for a female or 20 mm/hr for a male\\] and no radiographic progression \\[defined as change from baseline ≤ 0 in the total Sharp-Genant score, erosion score, and JSN score\\].'}, {'measure': 'End of Study: Percentage of Participants With ACR Response at Week 260', 'timeFrame': 'Baseline, Week 260', 'description': "ACR20/50/70/90 response is defined as a ≥ 20/50/70/90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate."}, {'measure': 'End of Study: Percentage of Participants With DAS28 Remission at Week 260', 'timeFrame': 'Week 260', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \\<2.6."}, {'measure': 'End of Study: Percentage of Participants With DAS28 Low Disease Activity (LDA) at Week 260', 'timeFrame': 'Week 260', 'description': "The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], patient's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDA is defined as DAS28 ≤3.2."}, {'measure': 'End of Study: Percentage of Participants With DAS28 European League Against Rheumatism (EULAR) Good or Moderate Response at Week 260', 'timeFrame': 'Baseline, Week 260', 'description': "The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. EULAR Good response: DAS28 ≤ 3.2 and a change from Baseline \\< -1.2. EULAR Moderate response: DAS28 \\>3.2 to ≤ 5.1 or a change from Baseline \\< -0.6 to ≥ -1.2."}, {'measure': 'End of Study: Change From Baseline in Swollen Joint Count at Week 260', 'timeFrame': 'Baseline, Week 260', 'description': '66 joints were assessed at Baseline and Week 260 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.'}, {'measure': 'End of Study: Change From Baseline in Tender Joint Count at Week 260', 'timeFrame': 'Baseline, Week 260', 'description': '68 joints were assessed at Baseline and Week 260 for tenderness and joints are classified as tender/not tender for a total possible swollen joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.'}, {'measure': 'End of Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 260', 'timeFrame': 'Baseline, Week 260', 'description': 'HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.'}, {'measure': "End of Study: Change From Baseline in the Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) at Week 260", 'timeFrame': 'Baseline, Week 260', 'description': 'The patient\'s global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.'}, {'measure': "End of Study: Change From Baseline in the Physician's Global Assessment of Disease Activity VAS at Week 260", 'timeFrame': 'Baseline, Week 260', 'description': 'The physician\'s global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.'}, {'measure': "End of Study: Change From Baseline in the Patient's Pain VAS at Week 260", 'timeFrame': 'Baseline, Week 260', 'description': 'The patient assessed their pain at Baseline and Week 260 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change from Baseline indicated improvement.'}, {'measure': 'End of Study: Percentage of Participants With Clinical Improvement in the FACIT-Fatigue Score at Week 260', 'timeFrame': 'Baseline, Week 260', 'description': "FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5 change from Baseline."}, {'measure': 'End of Study: Percentage of Participants With Clinical Relevant Improvement in the SF-36 Score at Week 260', 'timeFrame': 'Baseline, Week 260', 'description': 'The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. Clinically relevant improvement is defined as a ≥5 change from Baseline.'}, {'measure': 'End of Study: Change From Baseline in Total Sharp-Genant Score at Week 260', 'timeFrame': 'Baseline, Week 260', 'description': 'Radiographs were taken of each hand and foot at Baseline and Week 260 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint).The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score. The results were reported based on the treatment the patient was originally randomized to.'}, {'measure': 'End of Study: Change From Baseline in Erosion Score at Week 260', 'timeFrame': 'Baseline, Week 260', 'description': 'Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot and were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best ) to 142 (worst). A lower number change from Baseline indicated a better score.'}, {'measure': 'End of Study: Change From Baseline in Joint Space Narrowing Score at Week 260', 'timeFrame': 'Baseline, Week 260', 'description': 'Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '27564431', 'type': 'DERIVED', 'citation': 'Khawaja MN, Bergman MJ, Yourish J, Pei J, Reiss W, Keystone E. Routine Assessment of Patient Index Data 3 and the American College of Rheumatology/European League Against Rheumatism Provisional Remission Definitions as Predictors of Radiographic Outcome in a Rheumatoid Arthritis Clinical Trial With Tocilizumab. Arthritis Care Res (Hoboken). 2017 May;69(5):609-615. doi: 10.1002/acr.23008. Epub 2017 Apr 7.'}, {'pmid': '27087059', 'type': 'DERIVED', 'citation': 'Kremer JM, Blanco R, Halland AM, Brzosko M, Burgos-Vargas R, Mela CM, Rowell L, Fleischmann RM. Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial. Clin Exp Rheumatol. 2016 Jul-Aug;34(4):625-33. Epub 2016 Apr 15.'}, {'pmid': '26787505', 'type': 'DERIVED', 'citation': 'Bay-Jensen AC, Platt A, Siebuhr AS, Christiansen C, Byrjalsen I, Karsdal MA. Early changes in blood-based joint tissue destruction biomarkers are predictive of response to tocilizumab in the LITHE study. Arthritis Res Ther. 2016 Jan 20;18:13. doi: 10.1186/s13075-015-0913-x.'}, {'pmid': '24429164', 'type': 'DERIVED', 'citation': 'Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.'}, {'pmid': '23945134', 'type': 'DERIVED', 'citation': 'Siebuhr AS, Bay-Jensen AC, Leeming DJ, Plat A, Byrjalsen I, Christiansen C, van de Heijde D, Karsdal MA. Serological identification of fast progressors of structural damage with rheumatoid arthritis. Arthritis Res Ther. 2013 Aug 14;15(4):R86. doi: 10.1186/ar4266.'}, {'pmid': '23322466', 'type': 'DERIVED', 'citation': 'Fleischmann RM, Halland AM, Brzosko M, Burgos-Vargas R, Mela C, Vernon E, Kremer JM. Tocilizumab inhibits structural joint damage and improves physical function in patients with rheumatoid arthritis and inadequate responses to methotrexate: LITHE study 2-year results. J Rheumatol. 2013 Feb;40(2):113-26. doi: 10.3899/jrheum.120447. Epub 2013 Jan 15.'}, {'pmid': '22491018', 'type': 'DERIVED', 'citation': 'Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.'}, {'pmid': '21360490', 'type': 'DERIVED', 'citation': 'Kremer JM, Blanco R, Brzosko M, Burgos-Vargas R, Halland AM, Vernon E, Ambs P, Fleischmann R. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum. 2011 Mar;63(3):609-21. doi: 10.1002/art.30158.'}]}, 'descriptionModule': {'briefSummary': 'This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. After completion of the 2 year study participants could participate in the optional 3 year open label extension phase (year 3 to 5).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;\n* inadequate response to a stable dose of MTX;\n* patients of reproductive potential must be using reliable methods of contraception.\n\nExclusion Criteria:\n\n* major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;\n* prior treatment failure with an anti-tumor necrosis factor agent;\n* women who are pregnant or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT00106535', 'briefTitle': 'A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'WA17823'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tocilizumab 4 mg/kg + Methotrexate', 'description': 'Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with \\< 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a \\>70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.', 'interventionNames': ['Drug: tocilizumab [RoActemra/Actemra]', 'Drug: Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Tocilizumab 8 mg/kg + Methotrexate', 'description': 'Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with \\< 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a \\>70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.', 'interventionNames': ['Drug: tocilizumab [RoActemra/Actemra]', 'Drug: Methotrexate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Methotrexate', 'description': 'Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with \\< 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a \\>70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.', 'interventionNames': ['Drug: Placebo', 'Drug: Methotrexate']}], 'interventions': [{'name': 'tocilizumab [RoActemra/Actemra]', 'type': 'DRUG', 'otherNames': ['RoActemra', 'Actemra'], 'description': '4 mg/kg or 8 mg/kg IV/month every 4 weeks.', 'armGroupLabels': ['Tocilizumab 4 mg/kg + Methotrexate', 'Tocilizumab 8 mg/kg + Methotrexate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'IV/month', 'armGroupLabels': ['Placebo + Methotrexate']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': '10-25 mg/week', 'armGroupLabels': ['Placebo + Methotrexate', 'Tocilizumab 4 mg/kg + Methotrexate', 'Tocilizumab 8 mg/kg + Methotrexate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-7333', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 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