Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-01 @ 7:51 PM
Study NCT ID:
NCT00996203
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2009-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to 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'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}], 'ancestors': [{'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, '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 after the first publication or presentation that involves the overall study. 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 Visit up to 24 weeks or until withdrawal', 'eventGroups': [{'id': 'EG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.', 'otherNumAtRisk': 201, 'otherNumAffected': 46, 'seriousNumAtRisk': 201, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Lymphostasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyelonephritis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Skin reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Erysipelatous inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cervical myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Localized infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hemorrhagic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Toxic hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chronic bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Health Assessment Questionnaire (HAQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'title': 'Week 0 (n=201)', 'categories': [{'measurements': [{'value': '1.93', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=199)', 'categories': [{'measurements': [{'value': '1.49', 'spread': '0.65', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=198)', 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=196)', 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=193)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=193)', 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=193)', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Withdrawal visit (n=6)', 'categories': [{'measurements': [{'value': '1.32', 'spread': '1.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit', 'description': "HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population: All participants randomized in the study who received administration of at least one dose of the study drug and who had at least one efficacy assessment performed. n (number) = number of participants assessed at a specific visit.'}, {'type': 'SECONDARY', 'title': 'Pain Score as Assessed by Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'title': 'Week 0 (n=201)', 'categories': [{'measurements': [{'value': '63.82', 'spread': '16.71', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=199)', 'categories': [{'measurements': [{'value': '46.36', 'spread': '20.57', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=198)', 'categories': [{'measurements': [{'value': '36.48', 'spread': '18.94', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=196)', 'categories': [{'measurements': [{'value': '31.90', 'spread': '19.83', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=193)', 'categories': [{'measurements': [{'value': '26.92', 'spread': '18.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=193)', 'categories': [{'measurements': [{'value': '24.63', 'spread': '19.09', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=193)', 'categories': [{'measurements': [{'value': '21.96', 'spread': '18.87', 'groupId': 'OG000'}]}]}, {'title': 'Withdrawal visit (n=6)', 'categories': [{'measurements': [{'value': '34.50', 'spread': '22.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': "Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants assessed at a specific visit.'}, {'type': 'SECONDARY', 'title': 'European Quality of Life - 5 Dimensions (EQ-5D) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'title': 'Week 0 (n=200)', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=199)', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=198)', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=196)', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=193)', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=193)', 'categories': [{'measurements': [{'value': '0.66', 'spread': '0.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=193)', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Withdrawal visit (n=4)', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants assessed at a specific visit.'}, {'type': 'SECONDARY', 'title': 'Change in EQ-5D Score at Week 24 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'spread': '0.33', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'EQ-5D scores at Baseline Versus Week 24', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (\\<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D \\<0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'General Health Score as Assessed by EQ-5D VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'title': 'Week 0 (n=201)', 'categories': [{'measurements': [{'value': '39.27', 'spread': '18.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=199)', 'categories': [{'measurements': [{'value': '50.93', 'spread': '18.78', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=198)', 'categories': [{'measurements': [{'value': '61.79', 'spread': '43.45', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=196)', 'categories': [{'measurements': [{'value': '66.13', 'spread': '19.91', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=193)', 'categories': [{'measurements': [{'value': '70.48', 'spread': '19.39', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=192)', 'categories': [{'measurements': [{'value': '73.31', 'spread': '19.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=193)', 'categories': [{'measurements': [{'value': '76.22', 'spread': '19.25', 'groupId': 'OG000'}]}]}, {'title': 'Withdrawal visit (n=4)', 'categories': [{'measurements': [{'value': '60.50', 'spread': '27.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants assessed at a specific visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'title': 'Week 4 (n=198)', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=198)', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=196)', 'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=193)', 'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=193)', 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=193)', 'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase.', 'unitOfMeasure': 'percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants assessed at a specific visit.'}, {'type': 'SECONDARY', 'title': 'Change in General Health Assessed by VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '25.75', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'General health at baseline Versus Week 24', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score Based on 28-Joint Count (DAS28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'title': 'Week 0 (n=199)', 'categories': [{'measurements': [{'value': '6.748', 'spread': '0.852', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=197)', 'categories': [{'measurements': [{'value': '4.665', 'spread': '1.227', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=196)', 'categories': [{'measurements': [{'value': '3.777', 'spread': '1.279', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=193)', 'categories': [{'measurements': [{'value': '3.347', 'spread': '1.208', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=193)', 'categories': [{'measurements': [{'value': '2.956', 'spread': '1.230', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=192)', 'categories': [{'measurements': [{'value': '2.762', 'spread': '1.111', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=191)', 'categories': [{'measurements': [{'value': '2.637', 'spread': '1.157', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants assessed at a specific visit.'}, {'type': 'SECONDARY', 'title': 'Change in DAS28 Score From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.097', 'spread': '1.289', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline Versus Week 24 DAS28 scores', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'title': 'Week 4 ≥20% (n=199)', 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 ≥50% (n=199)', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 ≥70% (n=199)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 ≥20% (n=198)', 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 ≥50% (n=198)', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 ≥70% (n=198)', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 ≥ 20% (n=196)', 'categories': [{'measurements': [{'value': '83.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 ≥50% (n=196)', 'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 ≥70% (n=196)', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 ≥20% (n=193)', 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 ≥50% (n=193)', 'categories': [{'measurements': [{'value': '51.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 ≥70% (n=193)', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 ≥20% (n=193)', 'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 ≥50% (n=193)', 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 ≥70% (n=193)', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 ≥20% (n=193)', 'categories': [{'measurements': [{'value': '88.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 ≥50% (n=193)', 'categories': [{'measurements': [{'value': '61.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 ≥70% (n=193)', 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24', 'description': "HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population:'}, {'type': 'PRIMARY', 'title': 'Change in HAQ Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'spread': '0.66', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Mean HAQ scores at Baseline Versus Week 24', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': "HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'title': 'Week 0 moderate activity (n=199)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 0 high activity (n=199)', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 remission (n=197)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 low activity (n=197)', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 moderate activity (n=197)', 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 high activity (n=197)', 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 remission (n=196)', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 low activity (n=196)', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 moderate activity (n=196)', 'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 high activity (n=196)', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 remission (n=193)', 'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 low activity (n=193)', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 moderate activity (n=193)', 'categories': [{'measurements': [{'value': '42.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 high activity (n=193)', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 remission (n=193)', 'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 low activity (n=193)', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 moderate activity (n=193)', 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 high activity (n=193)', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 remission (n=192)', 'categories': [{'measurements': [{'value': '44.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 low activity (n=192)', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 moderate activity (n=192)', 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 high activity (n=192)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 remission (n=191)', 'categories': [{'measurements': [{'value': '51.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, low activity (n=191)', 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 moderate activity (n=191)', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 high activity (n=191)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR mm/hour, and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than \\[\\<\\] 2.6), I=low (DAS28 less than or equal to \\[≤\\]2.6 to \\<3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than \\[\\>\\]5.1).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants assessed at a specific visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'title': 'ACR20 Week 4', 'categories': [{'measurements': [{'value': '50.2', 'groupId': 'OG000'}]}]}, {'title': 'ACR20 Week 8', 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000'}]}]}, {'title': 'ACR20 Week 12', 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000'}]}]}, {'title': 'ACR20 Week 16', 'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000'}]}]}, {'title': 'ACR20 Week 20', 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000'}]}]}, {'title': 'ACR20 Week 24', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000'}]}]}, {'title': 'ACR50 Week 4', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'ACR50 Week 8', 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000'}]}]}, {'title': 'ACR50 Week 12', 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000'}]}]}, {'title': 'ACR50 Week 16', 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000'}]}]}, {'title': 'ACR50 Week 20', 'categories': [{'measurements': [{'value': '67.7', 'groupId': 'OG000'}]}]}, {'title': 'ACR50 Week 24', 'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}]}]}, {'title': 'ACR70 Week 4', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'ACR70 Week 8', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'ACR70 Week 12', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}]}]}, {'title': 'ACR70 Week 16', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}]}]}, {'title': 'ACR70 Week 20', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}]}]}, {'title': 'ACR70 Week 24', 'categories': [{'measurements': [{'value': '44.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase response: C-reactive protein (CRP) or ESR.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants assessed at a specific visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'title': 'Week 4, No effect (n=195)', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 4, Moderate effect (n=195)', 'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 4, Good effect (n=195)', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, No effect (n=194)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, Moderate effect (n=194)', 'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, Good effect (=194)', 'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, No effect (n=191)', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, Moderate effect (n=191)', 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, Good effect (n=191)', 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, No effect (n=191)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, Moderate effect (n=191)', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, Good effect (n=191)', 'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, No effect (n=190)', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, Moderate effect (n=190)', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, Good effect (n=190)', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, No effect (n=189)', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, Moderate effect (n=189)', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, Good effect (n=189)', 'categories': [{'measurements': [{'value': '70.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24', 'description': 'The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline \\>1.2 with DAS28 score ≤3.2; moderate effect: change from baseline \\>1.2 with DAS28 score 3.2 to 5.1 or change from baseline \\>0.6 to \\<1.2 with DAS28 score \\<3.2; no effect: change from baseline ≤0.6 or change from baseline \\>0.6 and ≤1.2 with DAS28 score \\>5.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants assessed at a specific visit.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'title': 'Week 0 (n=200)', 'categories': [{'measurements': [{'value': '33.51', 'spread': '34.86', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=198)', 'categories': [{'measurements': [{'value': '8.67', 'spread': '15.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=194)', 'categories': [{'measurements': [{'value': '7.62', 'spread': '19.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=196)', 'categories': [{'measurements': [{'value': '5.43', 'spread': '16.69', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=191)', 'categories': [{'measurements': [{'value': '4.66', 'spread': '13.48', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=193)', 'categories': [{'measurements': [{'value': '4.92', 'spread': '14.29', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=189)', 'categories': [{'measurements': [{'value': '4.78', 'spread': '12.94', 'groupId': 'OG000'}]}]}, {'title': 'Withdrawal visit (n=6)', 'categories': [{'measurements': [{'value': '7.00', 'spread': '0.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24', 'description': 'CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants assessed at a specific visit.'}, {'type': 'SECONDARY', 'title': 'Erythrocyte Sedimentation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'classes': [{'title': 'Week 0 (n=201)', 'categories': [{'measurements': [{'value': '53.33', 'spread': '30.82', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=198)', 'categories': [{'measurements': [{'value': '15.29', 'spread': '13.77', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=197)', 'categories': [{'measurements': [{'value': '11.97', 'spread': '14.95', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=193)', 'categories': [{'measurements': [{'value': '10.00', 'spread': '10.82', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=193)', 'categories': [{'measurements': [{'value': '11.63', 'spread': '17.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=193)', 'categories': [{'measurements': [{'value': '10.71', 'spread': '13.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=193)', 'categories': [{'measurements': [{'value': '10.95', 'spread': '13.52', 'groupId': 'OG000'}]}]}, {'title': 'Withdrawal visit (n=6)', 'categories': [{'measurements': [{'value': '15.00', 'spread': '4.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24', 'description': 'ESR (mm/hr) is used to determine the acute phase response.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants assessed at a specific visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (but not more than 800 mg), intravenously (IV), every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tocilizumab', 'description': 'Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'spread': '12.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '174', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population: All patients who received at least one dose and had at least one safety assessment after the drug administration.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2011-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-28', 'studyFirstSubmitDate': '2009-10-15', 'resultsFirstSubmitDate': '2014-04-07', 'studyFirstSubmitQcDate': '2009-10-15', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-06-30', 'studyFirstPostDateStruct': {'date': '2009-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Assessment Questionnaire (HAQ) Score', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit', 'description': "HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study."}, {'measure': 'Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24', 'description': "HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3."}, {'measure': 'Change in HAQ Score at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': "HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3."}], 'secondaryOutcomes': [{'measure': 'Pain Score as Assessed by Visual Analogue Scale (VAS)', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': "Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain."}, {'measure': 'European Quality of Life - 5 Dimensions (EQ-5D) Score', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.'}, {'measure': 'Change in EQ-5D Score at Week 24 From Baseline', 'timeFrame': 'Baseline and Week 24', 'description': 'EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (\\<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D \\<0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect.'}, {'measure': 'General Health Score as Assessed by EQ-5D VAS', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.'}, {'measure': 'Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase.'}, {'measure': 'Change in General Health Assessed by VAS', 'timeFrame': 'Baseline and Week 24', 'description': 'Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.'}, {'measure': 'Disease Activity Score Based on 28-Joint Count (DAS28)', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.'}, {'measure': 'Change in DAS28 Score From Baseline to Week 24', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR mm/hour, and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than \\[\\<\\] 2.6), I=low (DAS28 less than or equal to \\[≤\\]2.6 to \\<3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than \\[\\>\\]5.1).'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase response: C-reactive protein (CRP) or ESR.'}, {'measure': 'Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24', 'description': 'The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline \\>1.2 with DAS28 score ≤3.2; moderate effect: change from baseline \\>1.2 with DAS28 score 3.2 to 5.1 or change from baseline \\>0.6 to \\<1.2 with DAS28 score \\<3.2; no effect: change from baseline ≤0.6 or change from baseline \\>0.6 and ≤1.2 with DAS28 score \\>5.1.'}, {'measure': 'C-Reactive Protein', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24', 'description': 'CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein.'}, {'measure': 'Erythrocyte Sedimentation Rate', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24', 'description': 'ESR (mm/hr) is used to determine the acute phase response.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>/= 18 years of age\n* moderate to severe active rheumatoid arthritis of \\>/=6 months duration\n* inadequate clinical response to current non-biologic DMARDs\n* current DMARDs must be at stable dose for 8 weeks prior to study entry\n* oral corticosteroids (\\</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for \\>/=4 weeks prior to screening\n\nExclusion Criteria:\n\n* rheumatic autoimmune disease other than RA\n* history of or current inflammatory joint disease other than RA\n* previous treatment with any biologic DMARD\n* functional class IV as defined by the ACR classification\n* intra-articular or parenteral corticosteroids within 6 weeks prior to screening'}, 'identificationModule': {'nctId': 'NCT00996203', 'briefTitle': 'A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)', 'orgStudyIdInfo': {'id': 'ML22665'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: tocilizumab [RoActemra/Actemra]', 'Drug: DMARDs (disease-modifying antirheumatic drugs)']}], 'interventions': [{'name': 'tocilizumab [RoActemra/Actemra]', 'type': 'DRUG', 'description': '8 mg/kg iv every 4 weeks for 24 weeks', 'armGroupLabels': ['1']}, {'name': 'DMARDs (disease-modifying antirheumatic drugs)', 'type': 'DRUG', 'description': "stable doses at investigator's prescription", 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '454076', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Chelyabinsk Regional Clinical Hospital; Rheumatology', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '369000', 'city': 'Cherkess', 'country': 'Russia', 'facility': 'Republican clinical hospital of Karachai-Cherkess; Rheumatologic Department'}, {'zip': '664047', 'city': 'Irkutsk', 'country': 'Russia', 'facility': 'Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'zip': '426009', 'city': 'Izhevsk', 'country': 'Russia', 'facility': 'Republican Clinicodiagnostic Center', 'geoPoint': {'lat': 56.85225, 'lon': 53.19862}}, {'zip': '236016', 'city': 'Kaliningrad', 'country': 'Russia', 'facility': 'Kaliningrad Regional Clinical Hospital; Rheumatologic Department', 'geoPoint': {'lat': 54.70639, 'lon': 20.51102}}, {'zip': '650099', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'War Veterans Regional Clinical Hospital;Therapy Department', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '610028', 'city': 'Kirov', 'country': 'Russia', 'facility': 'Kirov Regional Clinical Hospital; Reumatology Department', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'zip': '350086', 'city': 'Krasnodar', 'country': 'Russia', 'facility': 'GUZ Regional clinical hospital # 1', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'zip': '305007', 'city': 'Kursk', 'country': 'Russia', 'facility': 'GMU Kursk regional clinical hospital', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'facility': 'FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115682', 'city': 'Moscow', 'country': 'Russia', 'facility': 'FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '121359', 'city': 'Moscow', 'country': 'Russia', 'facility': 'FGU Central Clinical Hospital with Polyclinic Administration President RF', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123060', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Head Clinical Hospital of Internal Affair Ministry of Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129110', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Vladimirskiy Regional Scientific Research Inst.', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603126', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'SIH Nizhny Novgorod Regional Clinical Hospital n.a. Semashko', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '185019', 'city': 'Petrozavodsk', 'country': 'Russia', 'facility': 'Republican Hospital Named After V.A. Baranov', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'zip': '344022', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Rostov State Medical University; Cardiorheumatology Department', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '214001', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Clinical hospital #1', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '628408', 'city': 'Surgut', 'country': 'Russia', 'facility': 'Surgut Region Clinical Hospital', 'geoPoint': {'lat': 61.25757, 'lon': 73.41775}}, {'zip': '625023', 'city': 'Tyumen', 'country': 'Russia', 'facility': 'Glpu Tjumen Regional Clinical Hospital #1', 'geoPoint': {'lat': 57.15222, 'lon': 65.52722}}, {'zip': '450005', 'city': 'Ufa', 'country': 'Russia', 'facility': 'Republican clinical hospital named after G.G. Kuvatov', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '432063', 'city': 'Ulyanovsk', 'country': 'Russia', 'facility': 'State Institution of Healthcare Ulyanovsk Regional Clinical Hospital', 'geoPoint': {'lat': 54.32824, 'lon': 48.38657}}, {'zip': '173008', 'city': 'Veliky Novgorod', 'country': 'Russia', 'facility': 'GUZ "Novgorod Regional Clinical Hospital"; Cardioreumatological', 'geoPoint': {'lat': 58.52131, 'lon': 31.27104}}, {'zip': '394066', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '394066', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Voronezh Regional Clinical Hospital #1', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '150062', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'SHI Yaroslavl Regional Clinical Hospital', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '620102', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '620102', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Sverdlovsk Regional Clinical Hospital # 1; Rheumatology Dept', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}