Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-01 @ 4:14 AM
Study NCT ID:
NCT01149057
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2010-06-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline up to 4 weeks after last dose of the study medication (up to Week 100)', 'eventGroups': [{'id': 'EG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.', 'otherNumAtRisk': 145, 'otherNumAffected': 134, 'seriousNumAtRisk': 145, 'seriousNumAffected': 36}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Alanine aminotransferase/Aspartate aminotransferase elevations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 47}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Exacerbation of rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea and Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Myocardial infarction (Acute myocardial infarction and Myocardial infarction)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastric fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pelvic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Alanine aminotransferase/Aspartate aminotransferase elevations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Catheterization cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cervix carcinoma stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cystocele repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Lens extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Obesity surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Type IV hypersensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Baseline (n=142)', 'categories': [{'measurements': [{'value': '21.2', 'spread': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 24 (n=118)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '9.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Analysis was performed using paired sample t-test for change from baseline.', 'statisticalMethod': 'Paired sample T-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analysed=participants with available data for this endpoint. Here, 'n' signifies participants with available data at specified time point."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'L1-L4: Baseline (n=40)', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '1.35', 'groupId': 'OG000'}]}]}, {'title': 'L1-L4: Change From Baseline at End (n=22)', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.39', 'groupId': 'OG000'}]}]}, {'title': 'Total Spine: Baseline (n=109)', 'categories': [{'measurements': [{'value': '-1.13', 'spread': '1.33', 'groupId': 'OG000'}]}]}, {'title': 'Total Spine: Change From Baseline at End (n=65)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.50', 'groupId': 'OG000'}]}]}, {'title': 'Total Hip-Left: Baseline (n=124)', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Total Hip-Left: Change From Baseline at End (n=76)', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.37', 'groupId': 'OG000'}]}]}, {'title': 'Neck-Left: Baseline (n=137)', 'categories': [{'measurements': [{'value': '-1.11', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Neck-Left: Change From Baseline at End (n=85)', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.36', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.3778', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P value by analysis of covariance (ANCOVA) for the change from baseline, adjusted to number of days between the first and the second DXA test.', 'groupDescription': 'Comparison of L1-L4 T-scores', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1541', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.', 'groupDescription': 'Comparison of Total spine T-score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7890', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.', 'groupDescription': 'Comparison of Total hip - left T-score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7094', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.', 'groupDescription': 'Comparison of Femoral neck - left T-scores.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of the study (up to Week 100)', 'description': 'BMD was measured by dual energy X-ray absorptiometry (DXA) and T-scores (a standard deviation \\[SD\\] compared with the peak BMD value of an adult aged from 20 to 30 years) were calculated. Osteopenia was defined by a T-score between -1 and -2.5 SD and osteoporosis as a T-score below -2.5 SD, according to the World Health Organization (WHO) guidelines. T-scores for L1-L4 lumbar spine, total spine, total hip (left), and femoral neck (left) were calculated.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number of participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Week 24 (n=115)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 (n=95)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Week 72 (n=73)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 (n=72)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 24, 48, 72 and 96', 'description': "Remission was defined as DAS28 score less than (\\<) 2.6. The DAS28 score was a measure of the participant'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 \\[VAS\\]: 0=no disease activity to 100=maximum disease activity) and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. In case of missing ESR value, C-Reactive Protein (CRP) was used to calculate DAS28. Higher scores represented higher disease activity.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Week 24 (n=115)', 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 (n=95)', 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 72 (n=73)', 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 (n=72)', 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 24, 48, 72 and 96', 'description': "Remission was defined as DAS28 score \\<2.6. The DAS28 score was a measure of the participant's disease activity calculated using the TJC \\[28 joints\\], SJC \\[28 joints\\], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Week 24 (n=114)', 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 (n=94)', 'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 72 (n=73)', 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 (n=72)', 'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 24, 48, 72 and 96', 'description': "The DAS28 score was a measure of the participant's disease activity calculated using the TJC \\[28 joints\\], SJC \\[28 joints\\], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity. EULAR Good response: DAS28 ≤3.2 and a change from Baseline \\<-1.2. EULAR Moderate response: DAS28 greater than (\\>) 3.2 to less than or equal to (≤) 5.1 or a change from Baseline \\<-0.6 to greater than or equal to (≥) -1.2.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Remission at Week 24 (n=107)', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'Low Disease Activity at Week 24 (n=107)', 'categories': [{'measurements': [{'value': '41.1', 'groupId': 'OG000'}]}]}, {'title': 'Remission at Week 48 (n=86)', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}]}]}, {'title': 'Low Disease Activity at Week 48 (n=86)', 'categories': [{'measurements': [{'value': '39.5', 'groupId': 'OG000'}]}]}, {'title': 'Remission at Week 72 (n=60)', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Low Disease Activity at Week 72 (n=60)', 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000'}]}]}, {'title': 'Remission at Week 96 (n=72)', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}]}]}, {'title': 'Low Disease Activity at Week 96 (n=72)', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 24, 48, 72 and 96', 'description': 'SDAI was calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0-10 centimeter \\[cm\\]), and level of CRP. SDAI total score 0-86; higher scores = greater effect due to disease activity. Remission was defined as SDAI score ≤3.3. Low disease activity was defined as SDAI score ≤11.0.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Remission at Week 24 (n=120)', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Low Disease Activity at Week 24 (n=120)', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}]}]}, {'title': 'Remission at Week 48 (n=97)', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}]}]}, {'title': 'Low Disease Activity at Week 48 (n=97)', 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000'}]}]}, {'title': 'Remission at Week 72 (n=75)', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}]}]}, {'title': 'Low Disease Activity at Week 72 (n=75)', 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000'}]}]}, {'title': 'Remission at Week 96 (n=80)', 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000'}]}]}, {'title': 'Low Disease Activity at Week 96 (n=80)', 'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 24, 48, 72 and 96', 'description': 'CDAI was calculated by a simple numerical sum of tender and swollen joint count (based on 28-joint assessment) and the patient and physician global disease assessment (VAS 0-10 cm). CDAI total score 0-76; higher scores = greater effect due to disease activity. Remission was defined as CDAI score ≤2.8. Low disease activity was defined as CDAI score ≤10.0.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in TJC At Weeks 24, 48, 72, and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Baseline (n=145)', 'categories': [{'measurements': [{'value': '22.8', 'spread': '14.2', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 24 (n=124)', 'categories': [{'measurements': [{'value': '-13.4', 'spread': '13.5', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 48 (n=99)', 'categories': [{'measurements': [{'value': '-15.2', 'spread': '13.4', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 72 (n=79)', 'categories': [{'measurements': [{'value': '-13.9', 'spread': '14.5', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 96 (n=84)', 'categories': [{'measurements': [{'value': '-14.5', 'spread': '12.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from baseline at Week 24', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from baseline at Week 48', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from baseline at Week 72', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from baseline at Week 96', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 24, 48, 72 and 96', '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. A negative change from baseline indicated improvement.', 'unitOfMeasure': 'tender joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Here, 'n' signifies the number of participants with available data at specified timepoints."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '10.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired sample T-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number of participants analyzed=participants with available data at specified time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '10.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired sample T-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number of participants analyzed=participants with available data at specified time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '10.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired sample T-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 96', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number of participants analyzed=participants with available data at specified time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Baseline (n=86)', 'categories': [{'measurements': [{'value': '20.9', 'spread': '10.9', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 24 (n=80)', 'categories': [{'measurements': [{'value': '5.0', 'spread': '9.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Analysis was performed using paired sample t-test for change from baseline.', 'statisticalMethod': 'Paired sample T-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Per Protocol (PP) population: all participants who completed the study. Number of participants analyzed=participants with available data for this outcome. Here 'n' signifies the participants with available data for specified time point."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '10.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired sample T-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '10.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired sample T-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '10.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired sample T-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 96', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SJC At Weeks 24, 48, 72, and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Baseline (n=145)', 'categories': [{'measurements': [{'value': '11.0', 'spread': '6.6', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 24 (n=124)', 'categories': [{'measurements': [{'value': '-7.3', 'spread': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 48 (n=99)', 'categories': [{'measurements': [{'value': '-7.3', 'spread': '6.4', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 72 (n=79)', 'categories': [{'measurements': [{'value': '-7.6', 'spread': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 96 (n=84)', 'categories': [{'measurements': [{'value': '-7.8', 'spread': '6.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from baseline at Week 24', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from baseline at Week 48', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from baseline at Week 72', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change from baseline at Week 96', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 24, 48, 72 and 96', '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. A negative change from baseline indicated improvement.', 'unitOfMeasure': 'swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Here, 'n' signifies the number of participants with available data at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'ACR20: Week 24 (n=121)', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}]}]}, {'title': 'ACR20: Week 48 (n=96)', 'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000'}]}]}, {'title': 'ACR20: Week 72 (n=76)', 'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000'}]}]}, {'title': 'ACR20: Week 96 (n=81)', 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000'}]}]}, {'title': 'ACR50: Week 24 (n=121)', 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000'}]}]}, {'title': 'ACR50: Week 48 (n=96)', 'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000'}]}]}, {'title': 'ACR50: Week 72 (n=76)', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}]}]}, {'title': 'ACR50: Week 96 (n=81)', 'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000'}]}]}, {'title': 'ACR70: Week 24 (n=121)', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}]}]}, {'title': 'ACR70: Week 48 (n=96)', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}]}]}, {'title': 'ACR70: Week 72 (n=76)', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}]}]}, {'title': 'ACR70: Week 96 (n=81)', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 24, 48, 72 and 96', 'description': 'ACR20 response: ≥20% improvement in TJC; ≥20% improvement in SJC; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ-DI\\]); and either CRP or ESR. ACR50 response required ≥50% improvement in the above criteria and ACR70 response required ≥70% improvement in the above criteria.', 'unitOfMeasure': 'percentage of partcipants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Baseline (n=138)', 'categories': [{'measurements': [{'value': '12.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 20 (n=122)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 44 (n=91)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 72 (n=73)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 96 (n=80)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 20, 44, 72 and 96', 'unitOfMeasure': 'gram per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'C-reactive Protein Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Baseline (n=133)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=114)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=116)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=112)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 36 (n=87)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 (n=89)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 72 (n=64)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 (n=75)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 8, 16, 24, 36 48, 72 and 96', 'unitOfMeasure': 'milligram per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Erythrocyte Sedimentation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Baseline (n=138)', 'categories': [{'measurements': [{'value': '45.3', 'spread': '27.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=125)', 'categories': [{'measurements': [{'value': '10.6', 'spread': '11.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=122)', 'categories': [{'measurements': [{'value': '11.3', 'spread': '14.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=118)', 'categories': [{'measurements': [{'value': '8.8', 'spread': '8.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 36 (n=99)', 'categories': [{'measurements': [{'value': '9.8', 'spread': '12.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 (n=96)', 'categories': [{'measurements': [{'value': '8.3', 'spread': '10.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 72 (n=76)', 'categories': [{'measurements': [{'value': '9.0', 'spread': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 (n=74)', 'categories': [{'measurements': [{'value': '7.4', 'spread': '8.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 8, 16, 24, 36 48, 72 and 96', 'unitOfMeasure': 'millimeter per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Participant Assessment of Pain (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Baseline (n=143)', 'categories': [{'measurements': [{'value': '70.3', 'spread': '22.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=136)', 'categories': [{'measurements': [{'value': '51.6', 'spread': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=132)', 'categories': [{'measurements': [{'value': '53.0', 'spread': '28.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=123)', 'categories': [{'measurements': [{'value': '49.4', 'spread': '26.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 36 (n=104)', 'categories': [{'measurements': [{'value': '44.7', 'spread': '28.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 (n=100)', 'categories': [{'measurements': [{'value': '46.3', 'spread': '28.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 72 (n=76)', 'categories': [{'measurements': [{'value': '42.3', 'spread': '27.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 (n=82)', 'categories': [{'measurements': [{'value': '44.9', 'spread': '28.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 8, 16, 24, 36 48, 72 and 96', 'description': 'The mean score of pain as assessed by participants using a 100-mm horizontal VAS, where the left endpoint (0) indicated "No pain," and the right endpoint (100) indicated "Unbearable pain". Higher score indicated higher pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'classes': [{'title': 'Baseline (n=138)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 24 (n=112)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 48 (n=92)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 72 (n=73)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Change From Baseline at Week 96 (n=81)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 24, 48, 72 and 96', 'description': 'HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 milligrams per kilograms (mg/kg) intravenous (IV) infusion every 4 weeks for a period of 96 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Positive Hepatitis B Core Antibody', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'B Cell Depletion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Participant Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'High Parathyroid Hormone Value', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '13.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '121', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) Population: all participants who have received any part of an infusion of the study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2010-06-22', 'resultsFirstSubmitDate': '2015-10-01', 'studyFirstSubmitQcDate': '2010-06-22', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-01', 'studyFirstPostDateStruct': {'date': '2010-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population', 'timeFrame': 'Baseline, Week 24', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score)."}, {'measure': 'Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population', 'timeFrame': 'Baseline, Week 48', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score)."}, {'measure': 'Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population', 'timeFrame': 'Baseline, Week 72', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score)."}, {'measure': 'Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population', 'timeFrame': 'Baseline, Week 96', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score)."}, {'measure': 'Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population', 'timeFrame': 'Baseline, Week 24', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score)."}, {'measure': 'Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population', 'timeFrame': 'Baseline, Week 48', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score)."}, {'measure': 'Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population', 'timeFrame': 'Baseline, Week 72', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score)."}, {'measure': 'Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population', 'timeFrame': 'Baseline, Week 96', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant'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 participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score)."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study', 'timeFrame': 'Baseline, End of the study (up to Week 100)', 'description': 'BMD was measured by dual energy X-ray absorptiometry (DXA) and T-scores (a standard deviation \\[SD\\] compared with the peak BMD value of an adult aged from 20 to 30 years) were calculated. Osteopenia was defined by a T-score between -1 and -2.5 SD and osteoporosis as a T-score below -2.5 SD, according to the World Health Organization (WHO) guidelines. T-scores for L1-L4 lumbar spine, total spine, total hip (left), and femoral neck (left) were calculated.'}, {'measure': 'Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96', 'timeFrame': 'Weeks 24, 48, 72 and 96', 'description': "Remission was defined as DAS28 score less than (\\<) 2.6. The DAS28 score was a measure of the participant'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 \\[VAS\\]: 0=no disease activity to 100=maximum disease activity) and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. In case of missing ESR value, C-Reactive Protein (CRP) was used to calculate DAS28. Higher scores represented higher disease activity."}, {'measure': 'Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96', 'timeFrame': 'Weeks 24, 48, 72 and 96', 'description': "Remission was defined as DAS28 score \\<2.6. The DAS28 score was a measure of the participant's disease activity calculated using the TJC \\[28 joints\\], SJC \\[28 joints\\], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity."}, {'measure': 'Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96', 'timeFrame': 'Weeks 24, 48, 72 and 96', 'description': "The DAS28 score was a measure of the participant's disease activity calculated using the TJC \\[28 joints\\], SJC \\[28 joints\\], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity. EULAR Good response: DAS28 ≤3.2 and a change from Baseline \\<-1.2. EULAR Moderate response: DAS28 greater than (\\>) 3.2 to less than or equal to (≤) 5.1 or a change from Baseline \\<-0.6 to greater than or equal to (≥) -1.2."}, {'measure': 'Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96', 'timeFrame': 'Weeks 24, 48, 72 and 96', 'description': 'SDAI was calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0-10 centimeter \\[cm\\]), and level of CRP. SDAI total score 0-86; higher scores = greater effect due to disease activity. Remission was defined as SDAI score ≤3.3. Low disease activity was defined as SDAI score ≤11.0.'}, {'measure': 'Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96', 'timeFrame': 'Weeks 24, 48, 72 and 96', 'description': 'CDAI was calculated by a simple numerical sum of tender and swollen joint count (based on 28-joint assessment) and the patient and physician global disease assessment (VAS 0-10 cm). CDAI total score 0-76; higher scores = greater effect due to disease activity. Remission was defined as CDAI score ≤2.8. Low disease activity was defined as CDAI score ≤10.0.'}, {'measure': 'Change From Baseline in TJC At Weeks 24, 48, 72, and 96', 'timeFrame': 'Baseline; Weeks 24, 48, 72 and 96', '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. A negative change from baseline indicated improvement.'}, {'measure': 'Change From Baseline in SJC At Weeks 24, 48, 72, and 96', 'timeFrame': 'Baseline; Weeks 24, 48, 72 and 96', '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. A negative change from baseline indicated improvement.'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96', 'timeFrame': 'Weeks 24, 48, 72 and 96', 'description': 'ACR20 response: ≥20% improvement in TJC; ≥20% improvement in SJC; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ-DI\\]); and either CRP or ESR. ACR50 response required ≥50% improvement in the above criteria and ACR70 response required ≥70% improvement in the above criteria.'}, {'measure': 'Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96', 'timeFrame': 'Baseline; Weeks 20, 44, 72 and 96'}, {'measure': 'C-reactive Protein Level', 'timeFrame': 'Baseline; Weeks 8, 16, 24, 36 48, 72 and 96'}, {'measure': 'Erythrocyte Sedimentation Rate', 'timeFrame': 'Baseline; Weeks 8, 16, 24, 36 48, 72 and 96'}, {'measure': 'Participant Assessment of Pain (VAS)', 'timeFrame': 'Baseline; Weeks 8, 16, 24, 36 48, 72 and 96', 'description': 'The mean score of pain as assessed by participants using a 100-mm horizontal VAS, where the left endpoint (0) indicated "No pain," and the right endpoint (100) indicated "Unbearable pain". Higher score indicated higher pain.'}, {'measure': 'Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96', 'timeFrame': 'Baseline; Weeks 24, 48, 72 and 96', 'description': 'HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive intravenous RoActemra/Actemra at a dose of 8 mg/kg every 4 weeks. Anticipated time on study treatment is 96 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/=18 years of age\n* Active moderate to severe rheumatoid arthritis\n* Inadequate response to \\>/=3 DMARDs (non-biologic and/or biologic)\n* Current treatment at stable dose for \\>/=8 weeks\n* Etanercept discontinued \\>/=2 weeks, Anakinra \\>/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab \\>/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab \\>/=16 weeks, and must have proven B-cell repletion\n\nExclusion Criteria:\n\n* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline\n* Rheumatic autoimmune disease other than RA\n* Functional class IV (American College of Rheumatology Classification)\n* Prior history or current inflammatory joint disease other than RA\n* Oral corticosteroids at a dose of \\>10 mg/day prednisone equivalent\n* Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core antibodies (HBcAb) or hepatitis C virus (HCV) antibody\n* Current or history of recurrent bacterial, viral, fungal or mycobaterial infection\n* History of or currently active primary or secondary immunodeficiency'}, 'identificationModule': {'nctId': 'NCT01149057', 'briefTitle': 'A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-Label Study to Evaluate the Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDs', 'orgStudyIdInfo': {'id': 'ML22873'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'interventionNames': ['Drug: tocilizumab [RoActemra/Actemra]']}], 'interventions': [{'name': 'tocilizumab [RoActemra/Actemra]', 'type': 'DRUG', 'description': '8 mg/kg intravenously, every 4 weeks for 96 weeks', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'zip': '78306', 'city': 'Ashkelon', 'country': 'Israel', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'zip': '6093000', 'city': 'Beer Yaakov', 'country': 'Israel'}, {'zip': '8410101', 'city': 'Beersheba', 'country': 'Israel', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '3339419', 'city': 'Haifa', 'country': 'Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '34362', 'city': 'Haifa', 'country': 'Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '58100', 'city': 'Holon', 'country': 'Israel', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'zip': '9112001', 'city': 'Jerusalem', 'country': 'Israel', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '91240', 'city': 'Jerusalem', 'country': 'Israel', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '4941492', 'city': 'Petah Tikva', 'country': 'Israel', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '5262000', 'city': 'Ramat Gan', 'country': 'Israel', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Clalit Health Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}