Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-03 @ 10:03 AM
Study NCT ID:
NCT01791205
Status:
COMPLETED
Last Update Posted:
2017-01-10
First Post:
2013-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ARMONIA: An Observational Study of Biologic Drugs in Monotherapy or Combination With DMARDs in Italian Clinical Practice and the Efficacy and Safety of RoActemra/Actemra (Tocilizumab) Monotherapy in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'global.trial_information@roche.com', 'phone': '+41 616878333', 'title': 'Roche Trial Information Hotline', 'organization': 'F. Hoffmann-La Roche AG'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 18 months', 'description': 'AEs are collected for participants who were enrolled in Phase I and received TCZ as a monotherapy for 18 months from the first infusion of TCZ in Phase II. AEs were not collected for participants who received Combination therapy.', 'eventGroups': [{'id': 'EG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.', 'otherNumAtRisk': 104, 'otherNumAffected': 54, 'seriousNumAtRisk': 104, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypogammaglobulinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ultrasound kidney abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hysteroscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gengival abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Genital candidasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vulvovaginal candidasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Keratitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Congenital neurological disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Procedural vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cystitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pharyngeal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tonsillitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Withdrawal hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Essential hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anal fistula excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac pacemaker insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dental operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Foot operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Uterine polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Synovectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'Age =< 59 years (n= 152, 152)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Age > 59 years (n= 152, 152)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Race Caucasian (n= 152, 152)', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}]}, {'title': 'Height =< 163 cm (n= 149, 150)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Height >163 cm (n= 149, 150)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Weight =< 65.85 Kg (n= 152, 152)', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Weight > 65.85 Kg, (n= 152, 152)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'BMI =< 24.98 Kg/cm^2 (n= 149, 150)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'BMI > 24.98 Kg/cm^2 (n= 149, 150)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Demographic characteristics were analyzed in participants at Baseline, where Baseline is considered as the study entry visit (day of informed consent form signed). Demographic characteristics which were taken into account included age in years, race, height in centimeters (cm), weight in Kilograms (Kg), and Body Mass Index (BMI) in Kg/cm\\^2. Participants with age =\\<, \\> 59 years, height =\\<, \\> 163 cm, weight =\\<, \\> 65.85 Kg and BMI =\\<, \\> 24.98 Kg/cm\\^2 are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as 'n'."}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With Disease Duration in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'Duration of disease =< 124 months', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Duration of disease > 124 months', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The duration of disease is defined as the total time from the diagnosis of rheumatoid arthritis (RA) until the study entry.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With Comorbidity in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Comorbidity is the presence of previous or concomitant diseases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With Autoantibody Status (Rheumatoid Factor and Anti-cyclic Citrullinated Protein Antibodies) in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'RF Positive (n= 128, 128)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'RF Negative (n= 128, 128)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Anti-CCP Positive (n= 100, 103)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Anti-CCP Negative (n= 100, 103)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The autoantibody included seropositive or seronegative participants for rheumatoid factor (RF) and/or anti-cyclic citrullinated protein antibodies (Anti-CCP). RF value higher than 20 Units (U)/milliliter (mL) is considered seropositive and anti-CCP antibodies value higher than 10 U/mL is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as 'n'."}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With Health Assessment Questionnaire- Disability Index in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'HAQ-DI Score =< 0.8625', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'HAQ-DI Score >0.8625', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The Health Assessment Questionnaire- Disability Index (HAQ-DI) is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days. Participants with scores =\\< 0.8625 and \\> 0.8625 are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. Participants with available data at the time of evaluation are reported.'}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With Disease Activity Score 28 in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'DAS28 with =< 2.6 score', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'DAS28 with >2.6 score', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The disease activity included Disease Activity Score 28 (DAS28). The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen joint counts (SJC) and tender joint counts (TJC), acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity; where higher scores represents higher disease activity. The DAS =\\< 2.8 indicates clinical remission, \\>2.8 to 10 = low disease activity, \\>10 to 22 = moderate disease activity, and \\>22 = high disease activity. Participants with DAS28 score =\\< 2.6 and \\> 2.6 are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. Participants with available data at Baseline are reported.'}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With C-Reactive Protein Value and Erythrocyte Sedimentation Rate in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'CRP =< 0.28 mg/dL (n= 128, 129)', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'CRP > 0.28 mg/dL (n= 128, 129)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'ESR =< 11 mm/h (n= 135, 136)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'ESR > 11 mm/h (n= 135, 136)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The disease activity included biological markers of inflammation: C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). A reduction in CRP and ESR values indicates improvement. Participants with CRP values =\\< 0.28 and \\>2.8 milligram/deciliter (mg/dL); and ESR values =\\< 11 and \\>11 millimeters/hour (mm/hr) are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants. Participants with available data at Baseline are reported. Participants with available data at specified time points are denoted as 'n'."}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With Clinical Disease Activity Index in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'CDAI Score =< 7.75', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'CDAI Score > 7.75', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': "The disease activity included Clinical Disease Activity Index (CDAI) which is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and patient's global assessment (PtGA) and physician's global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS), where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =\\< 2.8 indicates clinical remission, \\> 2.8 to 10 indicates low disease activity, \\> 10 to 22 indicates moderate disease activity, and \\> 22 indicates high disease activity. Participants with CDAI score =\\< 7.75 and \\> 7.75 are reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. Participants with available data at Baseline are reported.'}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With Simplified Disease Activity Index in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'SDAI Score =< 8.17', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'SDAI Score > 8.17', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The disease activity included Simplified Disease Activity Index (SDAI) which is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =\\< 3.3 indicates disease remission, \\> 3.4 to 11 indicates low disease activity, \\> 11 to 26 indicates moderate disease activity, and \\> 26 indicates high disease activity. Participants with SDAI score =\\< 8.17 and \\> 8.17 are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. Participants with available data at Baseline are reported.'}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With Duration of Combination Therapy Before Monotherapy in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'Duration of combination type 1, =< 337 (n= 81, 74)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Duration of combination type 1, > 337 (n= 81, 74)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Duration of combination type 2, =< 336 (n= 64, 60)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Duration of combination type 2, > 336 (n= 64, 60 )', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The duration of combination therapy before monotherapy are reported. The duration was estimated by calculating total duration from starting the combination therapy till the participant switched to monotherapy. Participants who started the combination therapy and later switched to monotherapy =\\< 337 days, \\> 337 days, =\\< 336 days, \\> 336 days are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as 'n'."}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants Treatment Line in Which Monotherapy Has Been Adopted in Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Treatment line, =< 2', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}, {'title': 'Treatment line, > 2', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs and the second treatment line as the subsequent use of a different biologic drug. Participants who adopted monotherapy as =\\< 2 and \\> 2 therapy lines are reported. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Biologics Administered as Monotherapy in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'No biologics', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}, {'title': 'At least one biologics', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Participants who received at least one previous treatment with biologics in monotherapy and no previous monotherapy with biologics are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'At least one switch', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'At least one swap', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'At least one switch/swap', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Participants who had prevalence with at least one previous switch, swaps, and switch/swap to other therapy are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With Reasons Leading to the Use of Biologic in Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'DMARDs intolerance', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Insufficient therapeutic effect', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Intolerance to biologic drug', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Low participant compliance', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Concomitant pathologies', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy desire', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Remission from combination therapy', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Remission from monotherapy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': "Reasons leading to the use of biologic in monotherapy includes DMARDs intolerance, insufficient therapeutic effect, intolerance to biologic drug, low participant's compliance, concomitant pathologies, pregnancy desire, remission from combination therapy, remission from monotherapy, others and unknown. Participants with reason leading to the use of biologic in monotherapy are presented. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Phase II: Percentage of Participants Who Retained on Tocilizumab Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000', 'lowerLimit': '93.4', 'upperLimit': '99.9'}]}]}, {'title': 'Day 33', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '91.3', 'upperLimit': '99.1'}]}]}, {'title': 'Day 66', 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '90.1', 'upperLimit': '98.5'}]}]}, {'title': 'Day 168', 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '98.0'}]}]}, {'title': 'Day 236', 'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000', 'lowerLimit': '87.6', 'upperLimit': '97.4'}]}]}, {'title': 'Day 323', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '86.4', 'upperLimit': '96.7'}]}]}, {'title': 'Day 375', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000', 'lowerLimit': '85.2', 'upperLimit': '96.1'}]}]}, {'title': 'Day 414', 'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000', 'lowerLimit': '84.0', 'upperLimit': '95.4'}]}]}, {'title': 'Day 423', 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000', 'lowerLimit': '82.9', 'upperLimit': '94.7'}]}]}, {'title': 'Day 442', 'categories': [{'measurements': [{'value': '89.4', 'groupId': 'OG000', 'lowerLimit': '81.7', 'upperLimit': '94.0'}]}]}, {'title': 'Day 459', 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '80.6', 'upperLimit': '93.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 18 months', 'description': 'The probabilities of participant to retain on therapy at various time points are reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'PRIMARY', 'title': 'Phase II: Retention Rate in Therapy, Percentage of Participants Achieving DAS 28 ESR <2.6 and <3.2 at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'DAS28 ESR<2.6', 'categories': [{'measurements': [{'value': '64.71', 'groupId': 'OG000', 'lowerLimit': '51.13', 'upperLimit': '78.28'}]}]}, {'title': 'DAS 28 ESR > 2.6 to =<3.2', 'categories': [{'measurements': [{'value': '80.39', 'groupId': 'OG000', 'lowerLimit': '69.11', 'upperLimit': '91.67'}]}]}], 'analyses': [{'pValue': '0.1194', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.538', 'ciLowerLimit': '0.65', 'ciUpperLimit': '19.33', 'pValueComment': 'The relation between retention rate and duration of disease for phase II was estimated with the Cox regression model.', 'groupDescription': 'The relation between retention rate and DAS28 (\\<2.6 vs \\<3.2) was assayed with the Cox regression.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At month 18', 'description': "Participants who retained the therapy were analyzed for disease activity (DAS28 ESR) at Month 18. The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'SECONDARY', 'title': 'Phase I: Median Disease Duration in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000', 'lowerLimit': '111', 'upperLimit': '150'}, {'value': '114', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '133'}]}]}], 'analyses': [{'pValue': '0.3895', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The duration of disease is defined as the total time from the diagnosis of RA until the study entry.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Phase I: Percentage of Participants With Comorbidity in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.61', 'groupId': 'OG000'}, {'value': '76.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4900', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.211', 'ciLowerLimit': '0.703', 'ciUpperLimit': '2.086', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Comorbidity is the presence of previous or concomitant diseases. Percentage of participants with comorbidity is reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Phase I: Mean Health Assessment Questionnaire-Disability Index in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.873', 'spread': '0.686', 'groupId': 'OG000'}, {'value': '0.915', 'spread': '0.667', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6908', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Delta', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.042', 'ciLowerLimit': '-0.251', 'ciUpperLimit': '0.167', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The HAQ-DI is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days.', 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Phase I: Percentage of Participants Who Started Treatment With a Biologic Drug in Monotherapy and Percentage of Participants Who Stopped a DMARDs While Taking a Biologic Drug in Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.01', 'groupId': 'OG000', 'lowerLimit': '40.9', 'upperLimit': '57.1'}, {'value': '35.81', 'groupId': 'OG001', 'lowerLimit': '28.0', 'upperLimit': '43.6'}]}]}], 'analyses': [{'pValue': '0.0210', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Pearson's chi-squared test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The table below shows percentage participants who started treatment with a biologic drug in monotherapy compared with percentage of participants who stopped DMARDs while taking a biologic drug in combination.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. One participant in monotherapy group and 4 participants in combination group were not included because they had not received a previous treatment.'}, {'type': 'SECONDARY', 'title': 'Phase I: Number of Participants Receiving a Biologic Drug as Monotherapy at Different Treatment Lines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Treatment Line 1', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Line 2', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Line 3', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Line 4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Line 5', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Line 6', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs, the second treatment line as the subsequent use of a different biologic drug and so on for the third, fourth, fifth and sixth treatment line. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Phase I: Number of Participants With at Least One Previous Treatment With Biologics Drug as a Monotherapy in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Number of participants who received at least one previous treatment with a biologic drug as a monotherapy in both groups is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. One participant in monotherapy group and 4 participants in combination group were not included because they had not received a previous treatment.'}, {'type': 'SECONDARY', 'title': 'Phase I: Percentage of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'Switch', 'categories': [{'measurements': [{'value': '19.74', 'groupId': 'OG000', 'lowerLimit': '13.34', 'upperLimit': '26.14'}, {'value': '26.32', 'groupId': 'OG001', 'lowerLimit': '19.24', 'upperLimit': '33.40'}]}]}, {'title': 'Swap', 'categories': [{'measurements': [{'value': '48.68', 'groupId': 'OG000', 'lowerLimit': '40.65', 'upperLimit': '56.72'}, {'value': '36.84', 'groupId': 'OG001', 'lowerLimit': '29.09', 'upperLimit': '44.60'}]}]}, {'title': 'Switch/Swap', 'categories': [{'measurements': [{'value': '53.29', 'groupId': 'OG000', 'lowerLimit': '45.27', 'upperLimit': '61.31'}, {'value': '49.34', 'groupId': 'OG001', 'lowerLimit': '41.30', 'upperLimit': '57.38'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Participants who had prevalence with at least one previous switch, swaps or switch/swap to other therapy either monotherapy or combination therapy are reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Phase I: Median DAS28 at Study Entry in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.51', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '6.28'}, {'value': '2.77', 'groupId': 'OG001', 'lowerLimit': '0.28', 'upperLimit': '6.27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity) where higher scores represents higher disease. The DAS28 \\<2.6 indicates disease remission, \\>=2.6 and \\<3.2 indicates Low disease activity, \\>=3.2 and \\<=5.1 indicates Moderate disease activity and \\>5.1 indicates High disease activity. Median score for DAS28 at the study entry (Baseline) is reported.', 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. Participants with available DAS28 score at Baseline are reported.'}, {'type': 'SECONDARY', 'title': 'Phase I: Number of Participants With CDAI Scores at Study Entry in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'Disease remission', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Low disease activity', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Moderate disease activity', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'High disease activity', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =\\< 2.8 indicates clinical remission, \\> 2.8 to 10 indicates low disease activity, \\> 10 to 22 indicates moderate disease activity, and \\> 22 indicates high disease activity. Number of participants with CDAI scores for both the groups at study entry (baseline) are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. Participants with available CDAI score at Baseline are reported.'}, {'type': 'SECONDARY', 'title': 'Phase I: Number of Participants With SDAI Scores at Study Entry in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'Disease remission', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Low disease activity', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Moderate disease activity', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'High disease activity', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (assessed on 0-10 cm) VAS; 0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =\\< 3.3 indicates disease remission, \\> 3.4 to 11 indicates low disease activity, \\> 11 to 26 indicates moderate disease activity, and \\> 26 indicates high disease activity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. Participants with available SDAI score at Baseline are reported.'}, {'type': 'SECONDARY', 'title': 'Phase I: Mean Tender Joints and Swollen Joints as Disease Activity at Study Entry in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'title': 'Tender Joints', 'categories': [{'measurements': [{'value': '2.49', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '2.71', 'spread': '3.75', 'groupId': 'OG001'}]}]}, {'title': 'Swollen Joints', 'categories': [{'measurements': [{'value': '1.29', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '2.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Mean of tender and swollen joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender and swollen joints was recorded on the joint assessment as no tenderness = 0 and tenderness = 1.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. Participants with available tender and swollen joints at Baseline are reported.'}, {'type': 'SECONDARY', 'title': 'Phase I: Percentage of Participants Treated With Corticosteroids at Study Entry in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.05', 'groupId': 'OG000', 'lowerLimit': '38.04', 'upperLimit': '54.07'}, {'value': '55.26', 'groupId': 'OG001', 'lowerLimit': '47.27', 'upperLimit': '63.26'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The percentage of participants treated with corticosteroids at enrollment is reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Phase I: Mean Dose of Corticosteroids At Study Entry in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.64', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '4.71', 'spread': '3.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Mean dose of corticosteroids at study entry (Baseline) is reported.', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. Participants who received corticosteroids were considered for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase I: Mean Duration of Previous Treatment With a Biologic Drug in Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '1254.7', 'spread': '816.0', 'groupId': 'OG000'}, {'value': '1188.3', 'spread': '995.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Mean duration of previous treatment with a biologic drug in monotherapy are reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. Participants who received previous treatment with a biologic drug before monotherapy were considered for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase I: Mean Duration of Treatment With A Biologic Drug in Combination With DMARDs Before Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'OG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'classes': [{'categories': [{'measurements': [{'value': '1486.1', 'spread': '988.4', 'groupId': 'OG000'}, {'value': '1525.9', 'spread': '1132.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Mean duration of treatment with a biologic drug in combination with DMARDs before monotherapy is reported in days.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants. Participants who received previous treatment with a biologic drug in combination with DMARDs before monotherapy were considered for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants Maintaining Delta DAS 28 CRP of >= 0.6 at Months 3, 6, 12, and 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '55.36', 'groupId': 'OG000', 'lowerLimit': '41.92', 'upperLimit': '68.79'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000', 'lowerLimit': '42.81', 'upperLimit': '70.4'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '60.78', 'groupId': 'OG000', 'lowerLimit': '46.92', 'upperLimit': '74.65'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '45.94', 'upperLimit': '74.06'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': 'Participants who maintained the change in DAS28 (Delta DAS28) CRP of \\>=0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported. The DAS28-CRP is a combined index that measured RA disease activity. It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC 28 + 0.28 square root of SJC 28 + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96. The DAS28 CRP- scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants Maintaining Delta DAS28 ESR >= 0.6 at Months 3, 6, 12, and 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '55.00', 'groupId': 'OG000', 'lowerLimit': '42.04', 'upperLimit': '67.96'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '67.86', 'groupId': 'OG000', 'lowerLimit': '55.24', 'upperLimit': '80.48'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '58.82', 'groupId': 'OG000', 'lowerLimit': '44.84', 'upperLimit': '72.8'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '72.55', 'groupId': 'OG000', 'lowerLimit': '59.87', 'upperLimit': '85.23'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': "Participants who maintained delta DAS28 ESR of \\>= 0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported. The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); where decrease in score indicated improvement of disease.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants Achieving DAS28 CRP Remission (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'DAS28 CRP < 2.6, Month 3', 'categories': [{'measurements': [{'value': '18.18', 'groupId': 'OG000', 'lowerLimit': '7.66', 'upperLimit': '28.7'}]}]}, {'title': 'DAS28 CRP < 2.6, Month 6', 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000', 'lowerLimit': '29.97', 'upperLimit': '56.24'}]}]}, {'title': 'DAS28 CRP < 2.6, Month 12', 'categories': [{'measurements': [{'value': '64.15', 'groupId': 'OG000', 'lowerLimit': '50.81', 'upperLimit': '77.5'}]}]}, {'title': 'DAS28 CRP < 2.6, Month 18', 'categories': [{'measurements': [{'value': '60.78', 'groupId': 'OG000', 'lowerLimit': '46.92', 'upperLimit': '74.65'}]}]}, {'title': 'DAS28 CRP < 3.2, Month 3', 'categories': [{'measurements': [{'value': '32.73', 'groupId': 'OG000', 'lowerLimit': '19.93', 'upperLimit': '45.53'}]}]}, {'title': 'DAS28 CRP < 3.2, Month 6', 'categories': [{'measurements': [{'value': '67.24', 'groupId': 'OG000', 'lowerLimit': '54.79', 'upperLimit': '79.69'}]}]}, {'title': 'DAS28 CRP < 3.2, Month 12', 'categories': [{'measurements': [{'value': '84.91', 'groupId': 'OG000', 'lowerLimit': '74.94', 'upperLimit': '94.87'}]}]}, {'title': 'DAS28 CRP < 3.2, Month 18', 'categories': [{'measurements': [{'value': '76.47', 'groupId': 'OG000', 'lowerLimit': '64.42', 'upperLimit': '88.52'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': 'The DAS28-CRP is a combined index that measured RA disease activity. It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC (28 joints) + 0.28 square root of SJC (28 joints) + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96. The DAS28 CRP scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease. The DAS28 CRP \\< 2.6 indicates disease remission and \\>=2.6 to 3.2 indicates low disease activity.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants Achieving DAS 28 ESR (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'DAS28 ESR < 2.6, Month 3', 'categories': [{'measurements': [{'value': '14.04', 'groupId': 'OG000', 'lowerLimit': '4.74', 'upperLimit': '23.33'}]}]}, {'title': 'DAS28 ESR < 2.6, Month 6', 'categories': [{'measurements': [{'value': '42.62', 'groupId': 'OG000', 'lowerLimit': '29.85', 'upperLimit': '55.39'}]}]}, {'title': 'DAS28 ESR < 2.6, Month 12', 'categories': [{'measurements': [{'value': '53.57', 'groupId': 'OG000', 'lowerLimit': '40.09', 'upperLimit': '67.05'}]}]}, {'title': 'DAS28 ESR < 2.6, Month 18', 'categories': [{'measurements': [{'value': '64.71', 'groupId': 'OG000', 'lowerLimit': '51.13', 'upperLimit': '78.28'}]}]}, {'title': 'DAS28 ESR < 3.2, Month 3', 'categories': [{'measurements': [{'value': '24.56', 'groupId': 'OG000', 'lowerLimit': '13.04', 'upperLimit': '36.08'}]}]}, {'title': 'DAS28 ESR < 3.2, Month 6', 'categories': [{'measurements': [{'value': '70.49', 'groupId': 'OG000', 'lowerLimit': '58.71', 'upperLimit': '82.27'}]}]}, {'title': 'DAS28 ESR < 3.2, Month 12', 'categories': [{'measurements': [{'value': '83.93', 'groupId': 'OG000', 'lowerLimit': '74.00', 'upperLimit': '93.85'}]}]}, {'title': 'DAS28 ESR < 3.2, Month 18', 'categories': [{'measurements': [{'value': '80.39', 'groupId': 'OG000', 'lowerLimit': '69.11', 'upperLimit': '91.67'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': "The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease. The DAS28 ESR \\< 2.6 indicates disease remission and \\>=2.6 to 3.2 indicates low disease activity.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants Achieving CDAI Remission (< 2.8) at Months 3, 6, 12, and 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '11.11', 'groupId': 'OG000', 'lowerLimit': '0.33', 'upperLimit': '21.9'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '16.67', 'groupId': 'OG000', 'lowerLimit': '3.88', 'upperLimit': '29.46'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '33.33', 'groupId': 'OG000', 'lowerLimit': '17.16', 'upperLimit': '49.51'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '31.58', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '47.06'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': 'Percentage of participants achieving CDAI remission \\< 2.8, after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported. CDAI is the numerical sum of four outcome parameters: TJC, SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =\\< 2.8 indicates clinical remission, \\> 2.8 to 10 indicates low disease activity, \\> 10 to 22 indicates moderate disease activity, and \\> 22 indicates high disease activity.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participant Achieving SDAI Remission (< 3.3) at Months 3, 6, 12, and 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '24.61'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '22.22', 'groupId': 'OG000', 'lowerLimit': '7.96', 'upperLimit': '36.49'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '50.00', 'groupId': 'OG000', 'lowerLimit': '32.29', 'upperLimit': '67.71'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '36.36', 'groupId': 'OG000', 'lowerLimit': '19.04', 'upperLimit': '53.69'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': 'Percentage of participant achieving SDAI remission (\\< 3.3), after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy is reported. The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA which (based on 0-10 cm VAS, 0 = no disease activity and 10 = worst disease activity, where higher scores represent higher disease activity), and CRP. The SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =\\< 3.3 indicates disease remission, \\> 3.4 to 11 = low disease activity, \\> 11 to 26 = moderate disease activity, and \\> 26 = high disease activity.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'SECONDARY', 'title': 'Phase II: Mean Change From Baseline in TJC And SJC at Months 3, 6, 12, and 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'TJC, Month 3 (n= 78)', 'categories': [{'measurements': [{'value': '-2.74', 'spread': '6.87', 'groupId': 'OG000'}]}]}, {'title': 'TJC, Month 6 (n= 80)', 'categories': [{'measurements': [{'value': '-4.13', 'spread': '5.51', 'groupId': 'OG000'}]}]}, {'title': 'TJC, Month 12 (n= 72)', 'categories': [{'measurements': [{'value': '-4.33', 'spread': '6.14', 'groupId': 'OG000'}]}]}, {'title': 'TJC, Month 18 (n= 69)', 'categories': [{'measurements': [{'value': '-4.30', 'spread': '5.89', 'groupId': 'OG000'}]}]}, {'title': 'SJC, Month 3 (n= 78)', 'categories': [{'measurements': [{'value': '-1.65', 'spread': '3.98', 'groupId': 'OG000'}]}]}, {'title': 'SJC, Month 6 (n= 80)', 'categories': [{'measurements': [{'value': '-2.39', 'spread': '3.47', 'groupId': 'OG000'}]}]}, {'title': 'SJC, Month 12 (n= 72)', 'categories': [{'measurements': [{'value': '-2.21', 'spread': '3.76', 'groupId': 'OG000'}]}]}, {'title': 'SJC, Month 18 (n= 69)', 'categories': [{'measurements': [{'value': '-2.46', 'spread': '3.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'The mean change from Baseline (day of the first infusion with tocilizumab as monotherapy) in the TJC And SJC after 3, 6, 12 and 18 months is reported. The TJC and SJC were determined for 28 joint counts. The scores ranged from 0 (no disease activity) to 28 (higher/worsen disease activity), where higher scores represents higher disease activity.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as 'n'."}, {'type': 'SECONDARY', 'title': 'Phase II: Mean Change From Baseline in Dose of Corticosteroids at Months 3, 6, 12, and 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Month 3 (n= 60)', 'categories': [{'measurements': [{'value': '-0.85', 'spread': '4.18', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n= 54)', 'categories': [{'measurements': [{'value': '-1.24', 'spread': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n= 41)', 'categories': [{'measurements': [{'value': '-1.71', 'spread': '2.76', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n= 38)', 'categories': [{'measurements': [{'value': '-1.08', 'spread': '2.12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'Mean Change From Baseline (day of the first infusion with tocilizumab as monotherapy) in the dose of corticosteroids after 3, 6, 12 and 18 months from Baseline is reported.', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as 'n'."}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With Delta HAQ >= 0.21 at Months 3, 6, 12, and 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '8.51', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '16.79'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '10.00', 'groupId': 'OG000', 'lowerLimit': '0.28', 'upperLimit': '19.72'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '13.89', 'groupId': 'OG000', 'lowerLimit': '2.02', 'upperLimit': '25.76'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '8.11', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '17.33'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': 'Percentage of participants with change in HAQ (Delta HAQ) of \\>= 0.21 after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported. The HAQ consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'SECONDARY', 'title': 'Phase II: Mean VAS Fatigue Score Overtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Baseline (n= 19)', 'categories': [{'measurements': [{'value': '54.95', 'spread': '25.49', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n= 24)', 'categories': [{'measurements': [{'value': '40.58', 'spread': '20.67', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n= 24)', 'categories': [{'measurements': [{'value': '30.42', 'spread': '21.20', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n= 17)', 'categories': [{'measurements': [{'value': '33.82', 'spread': '23.72', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n= 23)', 'categories': [{'measurements': [{'value': '23.35', 'spread': '25.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day of first administration of TCZ as a monotherapy) and Months 3, 6, 12, and 18', 'description': 'The VAS fatigue score ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity). Higher score indicate worsening.', 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as 'n'."}, {'type': 'SECONDARY', 'title': 'Phase II: Number of Participants With Any Adverse Events, Any Serious Adverse Events, Adverse Events of Special Interest, and Tubercular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'AE/SAE of special interest', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Tubercular AE/SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 18 months', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AE. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect. The AE were captured only for Phase II.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'SECONDARY', 'title': 'Phase II: Number of Participants With Retention in Therapy Without Interruption Due to Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 18 months', 'description': 'Number of participants who retained in therapy without interruption due to side effects is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'SECONDARY', 'title': 'Phase II: Number of Side Effects That Had Not Induced Discontinuation of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 18 months', 'description': 'Number of side effects (AEs) that had not induced discontinuation of treatment is reported. The AEs were captured only for Phase II.', 'unitOfMeasure': 'AEs', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'SECONDARY', 'title': 'Phase II: Number of Side Effects That Induced Transient Interruption of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 18 months', 'description': 'Number of side effects (AEs) that induced transient interruption of treatment is reported. The AEs were captured only for Phase II.', 'unitOfMeasure': 'AEs', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.'}, {'type': 'SECONDARY', 'title': 'Phase II: Mean Change From Baseline in Hemoglobin Levels Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Month 3 (n= 83)', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n= 84)', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n= 80)', 'categories': [{'measurements': [{'value': '0.44', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (n= 76)', 'categories': [{'measurements': [{'value': '0.49', 'spread': '1.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'The mean change in hemoglobin concentration was calculated by subtracting the baseline hemoglobin concentration from the monthly hemoglobin concentration is reported.', 'unitOfMeasure': 'gram/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as 'n'."}, {'type': 'SECONDARY', 'title': 'Phase II: Mean Change From Baseline in Hematocrit, Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Hematocrit, Month 3 (n= 60)', 'categories': [{'measurements': [{'value': '5.73', 'spread': '36.25', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Month 6 (n= 57)', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '7.12', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Month 12 (n= 57)', 'categories': [{'measurements': [{'value': '0.32', 'spread': '7.26', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Month 18 (n= 53)', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '8.35', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Month 3 (n= 61)', 'categories': [{'measurements': [{'value': '-7.82', 'spread': '11.96', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Month 6 (n= 64)', 'categories': [{'measurements': [{'value': '-7.69', 'spread': '11.35', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Month 12 (n= 57)', 'categories': [{'measurements': [{'value': '-7.16', 'spread': '11.99', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Month 18 (n= 55)', 'categories': [{'measurements': [{'value': '-6.69', 'spread': '13.32', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Month 3 (n= 58)', 'categories': [{'measurements': [{'value': '1.21', 'spread': '2.54', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Month 6 (n= 59)', 'categories': [{'measurements': [{'value': '1.25', 'spread': '2.11', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Month 12 (n= 52)', 'categories': [{'measurements': [{'value': '1.30', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Month 18 (n= 51)', 'categories': [{'measurements': [{'value': '1.31', 'spread': '2.16', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Month 3 (n= 58)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Month 6 (n= 59)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.63', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Month 12 (n= 52)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.47', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Month 18 (n= 51)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Month 3 (n= 60)', 'categories': [{'measurements': [{'value': '5.58', 'spread': '9.05', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Month 6 (n= 64)', 'categories': [{'measurements': [{'value': '5.60', 'spread': '9.50', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Month 12 (n= 57)', 'categories': [{'measurements': [{'value': '4.98', 'spread': '9.67', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Month 18 (n= 55)', 'categories': [{'measurements': [{'value': '4.55', 'spread': '11.45', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Month 3 (n= 58)', 'categories': [{'measurements': [{'value': '0.61', 'spread': '2.87', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Month 6 (n= 59)', 'categories': [{'measurements': [{'value': '1.13', 'spread': '2.75', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Month 12 (n= 52)', 'categories': [{'measurements': [{'value': '0.46', 'spread': '2.38', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Month 18 (n= 51)', 'categories': [{'measurements': [{'value': '0.59', 'spread': '2.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'Mean Change from Baseline in hematocrit, neutrophils, eosinophils, basophils, lymphocytes, monocytes are reported.', 'unitOfMeasure': 'Percentage of cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as 'n'."}, {'type': 'SECONDARY', 'title': 'Phase II: Mean Change From Baseline in Red Blood Cells, White Blood Cells, and Platelets Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'RBC, Month 3 (n= 71)', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': 'RBC, Month 6 (n= 70)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.30', 'groupId': 'OG000'}]}]}, {'title': 'RBC, Month 12 (n= 69)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': 'RBC, Month 18 (n= 63)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.29', 'groupId': 'OG000'}]}]}, {'title': 'WBC, Month 3 (n= 83)', 'categories': [{'measurements': [{'value': '-1.14', 'spread': '2.01', 'groupId': 'OG000'}]}]}, {'title': 'WBC, Month 6 (n= 84)', 'categories': [{'measurements': [{'value': '-1.30', 'spread': '2.27', 'groupId': 'OG000'}]}]}, {'title': 'WBC, Month 12 (n= 81)', 'categories': [{'measurements': [{'value': '-1.30', 'spread': '2.09', 'groupId': 'OG000'}]}]}, {'title': 'WBC, Month 18 (n= 75)', 'categories': [{'measurements': [{'value': '-1.48', 'spread': '2.15', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Month 3 (n= 78)', 'categories': [{'measurements': [{'value': '-52.38', 'spread': '71.21', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Month 6 (n= 75)', 'categories': [{'measurements': [{'value': '-62.12', 'spread': '72.58', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Month 12 (n= 73)', 'categories': [{'measurements': [{'value': '-54.42', 'spread': '73.40', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Month 18 (n= 72)', 'categories': [{'measurements': [{'value': '-57.88', 'spread': '76.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'Mean change from baseline in red blood cells (RBC), white blood cells (WBC) and platelets are reported.', 'unitOfMeasure': '10^6 cells/microliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as 'n'."}, {'type': 'SECONDARY', 'title': 'Phase II: Mean Change From Baseline in Total Cholesterol, Low-density and High-density Lipoprotein Cholesterol, Triglycerides, Total Bilirubin, Direct Bilirubin, Glucose, Creatinine, Blood Urea Nitrogen Levels Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Total Cholesterol, Month 3 (n= 27)', 'categories': [{'measurements': [{'value': '10.04', 'spread': '42.31', 'groupId': 'OG000'}]}]}, {'title': 'Total Cholesterol, Month 6 (n= 28)', 'categories': [{'measurements': [{'value': '12.61', 'spread': '49.76', 'groupId': 'OG000'}]}]}, {'title': 'Total Cholesterol, Month 12 (n= 31)', 'categories': [{'measurements': [{'value': '4.81', 'spread': '41.59', 'groupId': 'OG000'}]}]}, {'title': 'Total Cholesterol, Month 18 (n= 28)', 'categories': [{'measurements': [{'value': '5.57', 'spread': '49.00', 'groupId': 'OG000'}]}]}, {'title': 'LDL Cholesterol, Month 3 (n= 14)', 'categories': [{'measurements': [{'value': '-3.63', 'spread': '24.89', 'groupId': 'OG000'}]}]}, {'title': 'LDL Cholesterol, Month 6 (n= 14)', 'categories': [{'measurements': [{'value': '13.93', 'spread': '38.99', 'groupId': 'OG000'}]}]}, {'title': 'LDL Cholesterol, Month 12 (n= 16)', 'categories': [{'measurements': [{'value': '-2.59', 'spread': '37.10', 'groupId': 'OG000'}]}]}, {'title': 'LDL Cholesterol, Month 18 (n= 14)', 'categories': [{'measurements': [{'value': '3.53', 'spread': '38.31', 'groupId': 'OG000'}]}]}, {'title': 'HDL Cholesterol, Month 3 (n= 19)', 'categories': [{'measurements': [{'value': '4.16', 'spread': '6.34', 'groupId': 'OG000'}]}]}, {'title': 'HDL Cholesterol, Month 6 (n= 18)', 'categories': [{'measurements': [{'value': '0.67', 'spread': '11.42', 'groupId': 'OG000'}]}]}, {'title': 'HDL Cholesterol, Month 12 (n= 19)', 'categories': [{'measurements': [{'value': '-1.74', 'spread': '12.61', 'groupId': 'OG000'}]}]}, {'title': 'HDL Cholesterol, Month 18 (n= 18)', 'categories': [{'measurements': [{'value': '-1.67', 'spread': '15.46', 'groupId': 'OG000'}]}]}, {'title': 'TG, Month 3 (n= 23)', 'categories': [{'measurements': [{'value': '-7.91', 'spread': '45.29', 'groupId': 'OG000'}]}]}, {'title': 'TG, Month 6 (n= 27)', 'categories': [{'measurements': [{'value': '-2.78', 'spread': '50.39', 'groupId': 'OG000'}]}]}, {'title': 'TG, Month 12 (n= 26)', 'categories': [{'measurements': [{'value': '2.85', 'spread': '53.05', 'groupId': 'OG000'}]}]}, {'title': 'TG, Month 18 (n= 27)', 'categories': [{'measurements': [{'value': '12.93', 'spread': '71.09', 'groupId': 'OG000'}]}]}, {'title': 'Total Bilirubin, Month 3 (n= 5)', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.29', 'groupId': 'OG000'}]}]}, {'title': 'Total Bilirubin, Month 6 (n= 9)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.45', 'groupId': 'OG000'}]}]}, {'title': 'Total Bilirubin, Month 12 (n= 9)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.28', 'groupId': 'OG000'}]}]}, {'title': 'Total Bilirubin, Month 18 (n= 7)', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Direct Bilirubin, Month 3 (n= 5)', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.17', 'groupId': 'OG000'}]}]}, {'title': 'Direct Bilirubin, Month 6 (n= 9)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.28', 'groupId': 'OG000'}]}]}, {'title': 'Direct Bilirubin, Month 12 (n= 9)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.28', 'groupId': 'OG000'}]}]}, {'title': 'Direct Bilirubin, Month 18 (n= 7)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Month 3 (n= 16)', 'categories': [{'measurements': [{'value': '2.50', 'spread': '9.00', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Month 6 (n= 21)', 'categories': [{'measurements': [{'value': '4.13', 'spread': '29.90', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Month 12 (n= 24)', 'categories': [{'measurements': [{'value': '8.24', 'spread': '27.36', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Month 18 (n= 20)', 'categories': [{'measurements': [{'value': '-2.10', 'spread': '26.15', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Month 3 (n= 60)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Month 6 (n= 64)', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '1.29', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Month 12 (n= 60)', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '1.60', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Month 18 (n= 53)', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': 'BUN, Month 3 (n= 22)', 'categories': [{'measurements': [{'value': '1.31', 'spread': '8.87', 'groupId': 'OG000'}]}]}, {'title': 'BUN, Month 6 (n= 25)', 'categories': [{'measurements': [{'value': '1.14', 'spread': '8.80', 'groupId': 'OG000'}]}]}, {'title': 'BUN, Month 12 (n= 24)', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '8.31', 'groupId': 'OG000'}]}]}, {'title': 'BUN, Month 18 (n= 22)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '8.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'Mean change from baseline in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides (TG), total bilirubin, direct bilirubin, glucose, creatinine, blood urea nitrogen (BUN) levels are reported.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as 'n'."}, {'type': 'SECONDARY', 'title': 'Phase II: Mean Change From Baseline in Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyl Transpeptidase, and Alkaline Phosphatase Levels Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'AST, Month 3 (n= 74)', 'categories': [{'measurements': [{'value': '0.75', 'spread': '9.35', 'groupId': 'OG000'}]}]}, {'title': 'AST, Month 6 (n= 74)', 'categories': [{'measurements': [{'value': '0.87', 'spread': '9.39', 'groupId': 'OG000'}]}]}, {'title': 'AST, Month 12 (n= 74)', 'categories': [{'measurements': [{'value': '0.78', 'spread': '8.47', 'groupId': 'OG000'}]}]}, {'title': 'AST, Month 18 (n= 68)', 'categories': [{'measurements': [{'value': '1.53', 'spread': '13.40', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Month 3 (n= 74)', 'categories': [{'measurements': [{'value': '3.08', 'spread': '20.65', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Month 6 (n= 76)', 'categories': [{'measurements': [{'value': '0.60', 'spread': '20.49', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Month 12 (n= 76)', 'categories': [{'measurements': [{'value': '0.08', 'spread': '16.15', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Month 18 (n= 68)', 'categories': [{'measurements': [{'value': '0.22', 'spread': '18.27', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Month 3 (n= 25)', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '20.45', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Month 6 (n= 32)', 'categories': [{'measurements': [{'value': '-6.19', 'spread': '24.68', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Month 12 (n= 30)', 'categories': [{'measurements': [{'value': '-4.60', 'spread': '21.50', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Month 18 (n= 25)', 'categories': [{'measurements': [{'value': '-7.48', 'spread': '26.50', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Month 3 (n= 20)', 'categories': [{'measurements': [{'value': '-15.10', 'spread': '38.22', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Month 6 (n= 21)', 'categories': [{'measurements': [{'value': '-21.86', 'spread': '38.02', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Month 12 (n= 24)', 'categories': [{'measurements': [{'value': '-18.17', 'spread': '44.29', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Month 18 (n= 15)', 'categories': [{'measurements': [{'value': '-21.60', 'spread': '53.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'Mean change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase levels are reported.', 'unitOfMeasure': 'Units/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as 'n'."}, {'type': 'SECONDARY', 'title': 'Phase II: Mean Change From Baseline in Serum Electrophoresis Parameters Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}], 'classes': [{'title': 'Albumin, Month 3 (n= 25)', 'categories': [{'measurements': [{'value': '3.92', 'spread': '4.23', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Month 6 (n= 25)', 'categories': [{'measurements': [{'value': '5.23', 'spread': '3.29', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Month 12 (n= 24)', 'categories': [{'measurements': [{'value': '5.35', 'spread': '5.14', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Month 18 (n= 19)', 'categories': [{'measurements': [{'value': '5.95', 'spread': '4.45', 'groupId': 'OG000'}]}]}, {'title': 'Alpha-1 globulin, Month 3 (n= 26)', 'categories': [{'measurements': [{'value': '-0.85', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Alpha-1 globulin, Month 6 (n= 25)', 'categories': [{'measurements': [{'value': '-1.09', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Alpha-1 globulin, Month 12 (n= 25)', 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': 'Alpha-1 globulin, Month 18 (n= 19)', 'categories': [{'measurements': [{'value': '-1.11', 'spread': '1.03', 'groupId': 'OG000'}]}]}, {'title': 'Alpha-2 globulin, Month 3 (n= 25)', 'categories': [{'measurements': [{'value': '-1.74', 'spread': '2.12', 'groupId': 'OG000'}]}]}, {'title': 'Alpha-2 globulin, Month 6 (n= 25)', 'categories': [{'measurements': [{'value': '-1.68', 'spread': '2.30', 'groupId': 'OG000'}]}]}, {'title': 'Alpha-2 globulin, Month 12 (n= 24)', 'categories': [{'measurements': [{'value': '-1.91', 'spread': '1.95', 'groupId': 'OG000'}]}]}, {'title': 'Alpha-2 globulin, Month 18 (n= 19)', 'categories': [{'measurements': [{'value': '-2.34', 'spread': '1.89', 'groupId': 'OG000'}]}]}, {'title': 'Beta globulin, Month 3 (n= 25)', 'categories': [{'measurements': [{'value': '-0.94', 'spread': '1.36', 'groupId': 'OG000'}]}]}, {'title': 'Beta globulin, Month 6 (n= 24)', 'categories': [{'measurements': [{'value': '-1.19', 'spread': '1.43', 'groupId': 'OG000'}]}]}, {'title': 'Beta globulin, Month 12 (n= 24)', 'categories': [{'measurements': [{'value': '-0.91', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Beta globulin, Month 18 (n= 19)', 'categories': [{'measurements': [{'value': '-1.07', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'Gamma globulin, Month 3 (n= 25)', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '1.96', 'groupId': 'OG000'}]}]}, {'title': 'Gamma globulin, Month 6 (n= 26)', 'categories': [{'measurements': [{'value': '-1.75', 'spread': '3.46', 'groupId': 'OG000'}]}]}, {'title': 'Gamma globulin, Month 12 (n= 24)', 'categories': [{'measurements': [{'value': '-1.51', 'spread': '2.44', 'groupId': 'OG000'}]}]}, {'title': 'Gamma globulin, Month 18 (n= 19)', 'categories': [{'measurements': [{'value': '-1.52', 'spread': '2.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'Serum electrophoresis parameters includes albumin, alpha-1 globulin, alpha-2 globulin, beta globulin, gamma globulin was reported. Mean change from Baseline values are reported at each time points.', 'unitOfMeasure': 'Percentage of concentration', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as 'n'."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received tocilizumab (TCZ) as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'FG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}], 'periods': [{'title': 'Phase I', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Phase II', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who received tocilizumab monotherapy in Phase I was observed in Phase II.', 'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Safety', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Remission of disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': "Physician's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 304 participants were enrolled in the study conducted from May 2013 to October 2014 at 29 centers in Italy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'id': 'BG001', 'title': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '59.4', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '58.4', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population included all enrolled participants.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-14', 'studyFirstSubmitDate': '2013-02-12', 'resultsFirstSubmitDate': '2016-06-30', 'studyFirstSubmitQcDate': '2013-02-12', 'lastUpdatePostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-14', 'studyFirstPostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Demographic characteristics were analyzed in participants at Baseline, where Baseline is considered as the study entry visit (day of informed consent form signed). Demographic characteristics which were taken into account included age in years, race, height in centimeters (cm), weight in Kilograms (Kg), and Body Mass Index (BMI) in Kg/cm\\^2. Participants with age =\\<, \\> 59 years, height =\\<, \\> 163 cm, weight =\\<, \\> 65.85 Kg and BMI =\\<, \\> 24.98 Kg/cm\\^2 are reported.'}, {'measure': 'Phase I: Number of Participants With Disease Duration in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The duration of disease is defined as the total time from the diagnosis of rheumatoid arthritis (RA) until the study entry.'}, {'measure': 'Phase I: Number of Participants With Comorbidity in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Comorbidity is the presence of previous or concomitant diseases.'}, {'measure': 'Phase I: Number of Participants With Autoantibody Status (Rheumatoid Factor and Anti-cyclic Citrullinated Protein Antibodies) in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The autoantibody included seropositive or seronegative participants for rheumatoid factor (RF) and/or anti-cyclic citrullinated protein antibodies (Anti-CCP). RF value higher than 20 Units (U)/milliliter (mL) is considered seropositive and anti-CCP antibodies value higher than 10 U/mL is considered positive.'}, {'measure': 'Phase I: Number of Participants With Health Assessment Questionnaire- Disability Index in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The Health Assessment Questionnaire- Disability Index (HAQ-DI) is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days. Participants with scores =\\< 0.8625 and \\> 0.8625 are reported.'}, {'measure': 'Phase I: Number of Participants With Disease Activity Score 28 in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The disease activity included Disease Activity Score 28 (DAS28). The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen joint counts (SJC) and tender joint counts (TJC), acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity; where higher scores represents higher disease activity. The DAS =\\< 2.8 indicates clinical remission, \\>2.8 to 10 = low disease activity, \\>10 to 22 = moderate disease activity, and \\>22 = high disease activity. Participants with DAS28 score =\\< 2.6 and \\> 2.6 are reported.'}, {'measure': 'Phase I: Number of Participants With C-Reactive Protein Value and Erythrocyte Sedimentation Rate in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The disease activity included biological markers of inflammation: C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). A reduction in CRP and ESR values indicates improvement. Participants with CRP values =\\< 0.28 and \\>2.8 milligram/deciliter (mg/dL); and ESR values =\\< 11 and \\>11 millimeters/hour (mm/hr) are reported.'}, {'measure': 'Phase I: Number of Participants With Clinical Disease Activity Index in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': "The disease activity included Clinical Disease Activity Index (CDAI) which is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and patient's global assessment (PtGA) and physician's global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS), where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =\\< 2.8 indicates clinical remission, \\> 2.8 to 10 indicates low disease activity, \\> 10 to 22 indicates moderate disease activity, and \\> 22 indicates high disease activity. Participants with CDAI score =\\< 7.75 and \\> 7.75 are reported."}, {'measure': 'Phase I: Number of Participants With Simplified Disease Activity Index in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The disease activity included Simplified Disease Activity Index (SDAI) which is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =\\< 3.3 indicates disease remission, \\> 3.4 to 11 indicates low disease activity, \\> 11 to 26 indicates moderate disease activity, and \\> 26 indicates high disease activity. Participants with SDAI score =\\< 8.17 and \\> 8.17 are reported.'}, {'measure': 'Phase I: Number of Participants With Duration of Combination Therapy Before Monotherapy in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The duration of combination therapy before monotherapy are reported. The duration was estimated by calculating total duration from starting the combination therapy till the participant switched to monotherapy. Participants who started the combination therapy and later switched to monotherapy =\\< 337 days, \\> 337 days, =\\< 336 days, \\> 336 days are reported.'}, {'measure': 'Phase I: Number of Participants Treatment Line in Which Monotherapy Has Been Adopted in Monotherapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs and the second treatment line as the subsequent use of a different biologic drug. Participants who adopted monotherapy as =\\< 2 and \\> 2 therapy lines are reported. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.'}, {'measure': 'Phase I: Number of Biologics Administered as Monotherapy in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Participants who received at least one previous treatment with biologics in monotherapy and no previous monotherapy with biologics are reported.'}, {'measure': 'Phase I: Number of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Participants who had prevalence with at least one previous switch, swaps, and switch/swap to other therapy are reported.'}, {'measure': 'Phase I: Number of Participants With Reasons Leading to the Use of Biologic in Monotherapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': "Reasons leading to the use of biologic in monotherapy includes DMARDs intolerance, insufficient therapeutic effect, intolerance to biologic drug, low participant's compliance, concomitant pathologies, pregnancy desire, remission from combination therapy, remission from monotherapy, others and unknown. Participants with reason leading to the use of biologic in monotherapy are presented. According to the study protocol objectives, this analysis was performed only for Monotherapy arm."}, {'measure': 'Phase II: Percentage of Participants Who Retained on Tocilizumab Monotherapy', 'timeFrame': 'Up to 18 months', 'description': 'The probabilities of participant to retain on therapy at various time points are reported.'}, {'measure': 'Phase II: Retention Rate in Therapy, Percentage of Participants Achieving DAS 28 ESR <2.6 and <3.2 at Month 18', 'timeFrame': 'At month 18', 'description': "Participants who retained the therapy were analyzed for disease activity (DAS28 ESR) at Month 18. The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease."}], 'secondaryOutcomes': [{'measure': 'Phase I: Median Disease Duration in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The duration of disease is defined as the total time from the diagnosis of RA until the study entry.'}, {'measure': 'Phase I: Percentage of Participants With Comorbidity in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Comorbidity is the presence of previous or concomitant diseases. Percentage of participants with comorbidity is reported.'}, {'measure': 'Phase I: Mean Health Assessment Questionnaire-Disability Index in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The HAQ-DI is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days.'}, {'measure': 'Phase I: Percentage of Participants Who Started Treatment With a Biologic Drug in Monotherapy and Percentage of Participants Who Stopped a DMARDs While Taking a Biologic Drug in Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The table below shows percentage participants who started treatment with a biologic drug in monotherapy compared with percentage of participants who stopped DMARDs while taking a biologic drug in combination.'}, {'measure': 'Phase I: Number of Participants Receiving a Biologic Drug as Monotherapy at Different Treatment Lines', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs, the second treatment line as the subsequent use of a different biologic drug and so on for the third, fourth, fifth and sixth treatment line. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.'}, {'measure': 'Phase I: Number of Participants With at Least One Previous Treatment With Biologics Drug as a Monotherapy in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Number of participants who received at least one previous treatment with a biologic drug as a monotherapy in both groups is reported.'}, {'measure': 'Phase I: Percentage of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Participants who had prevalence with at least one previous switch, swaps or switch/swap to other therapy either monotherapy or combination therapy are reported.'}, {'measure': 'Phase I: Median DAS28 at Study Entry in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity) where higher scores represents higher disease. The DAS28 \\<2.6 indicates disease remission, \\>=2.6 and \\<3.2 indicates Low disease activity, \\>=3.2 and \\<=5.1 indicates Moderate disease activity and \\>5.1 indicates High disease activity. Median score for DAS28 at the study entry (Baseline) is reported.'}, {'measure': 'Phase I: Number of Participants With CDAI Scores at Study Entry in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =\\< 2.8 indicates clinical remission, \\> 2.8 to 10 indicates low disease activity, \\> 10 to 22 indicates moderate disease activity, and \\> 22 indicates high disease activity. Number of participants with CDAI scores for both the groups at study entry (baseline) are reported.'}, {'measure': 'Phase I: Number of Participants With SDAI Scores at Study Entry in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (assessed on 0-10 cm) VAS; 0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =\\< 3.3 indicates disease remission, \\> 3.4 to 11 indicates low disease activity, \\> 11 to 26 indicates moderate disease activity, and \\> 26 indicates high disease activity.'}, {'measure': 'Phase I: Mean Tender Joints and Swollen Joints as Disease Activity at Study Entry in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Mean of tender and swollen joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender and swollen joints was recorded on the joint assessment as no tenderness = 0 and tenderness = 1.'}, {'measure': 'Phase I: Percentage of Participants Treated With Corticosteroids at Study Entry in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'The percentage of participants treated with corticosteroids at enrollment is reported.'}, {'measure': 'Phase I: Mean Dose of Corticosteroids At Study Entry in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Mean dose of corticosteroids at study entry (Baseline) is reported.'}, {'measure': 'Phase I: Mean Duration of Previous Treatment With a Biologic Drug in Monotherapy and Combination Therapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Mean duration of previous treatment with a biologic drug in monotherapy are reported.'}, {'measure': 'Phase I: Mean Duration of Treatment With A Biologic Drug in Combination With DMARDs Before Monotherapy', 'timeFrame': 'At Baseline (Day of informed consent form signed)', 'description': 'Mean duration of treatment with a biologic drug in combination with DMARDs before monotherapy is reported in days.'}, {'measure': 'Phase II: Percentage of Participants Maintaining Delta DAS 28 CRP of >= 0.6 at Months 3, 6, 12, and 18', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': 'Participants who maintained the change in DAS28 (Delta DAS28) CRP of \\>=0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported. The DAS28-CRP is a combined index that measured RA disease activity. It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC 28 + 0.28 square root of SJC 28 + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96. The DAS28 CRP- scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.'}, {'measure': 'Phase II: Percentage of Participants Maintaining Delta DAS28 ESR >= 0.6 at Months 3, 6, 12, and 18', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': "Participants who maintained delta DAS28 ESR of \\>= 0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported. The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); where decrease in score indicated improvement of disease."}, {'measure': 'Phase II: Percentage of Participants Achieving DAS28 CRP Remission (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': 'The DAS28-CRP is a combined index that measured RA disease activity. It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC (28 joints) + 0.28 square root of SJC (28 joints) + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96. The DAS28 CRP scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease. The DAS28 CRP \\< 2.6 indicates disease remission and \\>=2.6 to 3.2 indicates low disease activity.'}, {'measure': 'Phase II: Percentage of Participants Achieving DAS 28 ESR (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': "The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease. The DAS28 ESR \\< 2.6 indicates disease remission and \\>=2.6 to 3.2 indicates low disease activity."}, {'measure': 'Phase II: Percentage of Participants Achieving CDAI Remission (< 2.8) at Months 3, 6, 12, and 18', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': 'Percentage of participants achieving CDAI remission \\< 2.8, after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported. CDAI is the numerical sum of four outcome parameters: TJC, SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =\\< 2.8 indicates clinical remission, \\> 2.8 to 10 indicates low disease activity, \\> 10 to 22 indicates moderate disease activity, and \\> 22 indicates high disease activity.'}, {'measure': 'Phase II: Percentage of Participant Achieving SDAI Remission (< 3.3) at Months 3, 6, 12, and 18', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': 'Percentage of participant achieving SDAI remission (\\< 3.3), after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy is reported. The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA which (based on 0-10 cm VAS, 0 = no disease activity and 10 = worst disease activity, where higher scores represent higher disease activity), and CRP. The SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =\\< 3.3 indicates disease remission, \\> 3.4 to 11 = low disease activity, \\> 11 to 26 = moderate disease activity, and \\> 26 = high disease activity.'}, {'measure': 'Phase II: Mean Change From Baseline in TJC And SJC at Months 3, 6, 12, and 18', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'The mean change from Baseline (day of the first infusion with tocilizumab as monotherapy) in the TJC And SJC after 3, 6, 12 and 18 months is reported. The TJC and SJC were determined for 28 joint counts. The scores ranged from 0 (no disease activity) to 28 (higher/worsen disease activity), where higher scores represents higher disease activity.'}, {'measure': 'Phase II: Mean Change From Baseline in Dose of Corticosteroids at Months 3, 6, 12, and 18', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'Mean Change From Baseline (day of the first infusion with tocilizumab as monotherapy) in the dose of corticosteroids after 3, 6, 12 and 18 months from Baseline is reported.'}, {'measure': 'Phase II: Percentage of Participants With Delta HAQ >= 0.21 at Months 3, 6, 12, and 18', 'timeFrame': 'At Months 3, 6, 12, and 18', 'description': 'Percentage of participants with change in HAQ (Delta HAQ) of \\>= 0.21 after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported. The HAQ consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity.'}, {'measure': 'Phase II: Mean VAS Fatigue Score Overtime', 'timeFrame': 'At Baseline (Day of first administration of TCZ as a monotherapy) and Months 3, 6, 12, and 18', 'description': 'The VAS fatigue score ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity). Higher score indicate worsening.'}, {'measure': 'Phase II: Number of Participants With Any Adverse Events, Any Serious Adverse Events, Adverse Events of Special Interest, and Tubercular Events', 'timeFrame': 'Up to 18 months', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AE. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect. The AE were captured only for Phase II.'}, {'measure': 'Phase II: Number of Participants With Retention in Therapy Without Interruption Due to Side Effects', 'timeFrame': 'Up to 18 months', 'description': 'Number of participants who retained in therapy without interruption due to side effects is reported.'}, {'measure': 'Phase II: Number of Side Effects That Had Not Induced Discontinuation of Treatment', 'timeFrame': 'Up to 18 months', 'description': 'Number of side effects (AEs) that had not induced discontinuation of treatment is reported. The AEs were captured only for Phase II.'}, {'measure': 'Phase II: Number of Side Effects That Induced Transient Interruption of Treatment', 'timeFrame': 'Up to 18 months', 'description': 'Number of side effects (AEs) that induced transient interruption of treatment is reported. The AEs were captured only for Phase II.'}, {'measure': 'Phase II: Mean Change From Baseline in Hemoglobin Levels Over Time', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'The mean change in hemoglobin concentration was calculated by subtracting the baseline hemoglobin concentration from the monthly hemoglobin concentration is reported.'}, {'measure': 'Phase II: Mean Change From Baseline in Hematocrit, Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes Over Time', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'Mean Change from Baseline in hematocrit, neutrophils, eosinophils, basophils, lymphocytes, monocytes are reported.'}, {'measure': 'Phase II: Mean Change From Baseline in Red Blood Cells, White Blood Cells, and Platelets Over Time', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'Mean change from baseline in red blood cells (RBC), white blood cells (WBC) and platelets are reported.'}, {'measure': 'Phase II: Mean Change From Baseline in Total Cholesterol, Low-density and High-density Lipoprotein Cholesterol, Triglycerides, Total Bilirubin, Direct Bilirubin, Glucose, Creatinine, Blood Urea Nitrogen Levels Over Time', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'Mean change from baseline in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides (TG), total bilirubin, direct bilirubin, glucose, creatinine, blood urea nitrogen (BUN) levels are reported.'}, {'measure': 'Phase II: Mean Change From Baseline in Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyl Transpeptidase, and Alkaline Phosphatase Levels Over Time', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'Mean change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase levels are reported.'}, {'measure': 'Phase II: Mean Change From Baseline in Serum Electrophoresis Parameters Over Time', 'timeFrame': 'From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18', 'description': 'Serum electrophoresis parameters includes albumin, alpha-1 globulin, alpha-2 globulin, beta globulin, gamma globulin was reported. Mean change from Baseline values are reported at each time points.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is a multicenter observational study in patients with rheumatoid arthritis in routine clinical practice in Italy. In the retrospective Part 1 of the study, clinical and demographic factors associated with the use of a biologic drug in monotherapy as compared to therapy in combination with Disease-modifying anti-rheumatic drugs (DMARDs) will be evaluated. In the retrospective/prospective Part 2 of the study, efficacy and safety of the use of RoActemra/Actemra (tocilizumab) in monotherapy will be evaluated. Patients will be followed for up to18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rheumatoid arthritis who have received at least one cycle of therapy with a biologic drug in monotherapy or in combination with DMARDs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart 1:\n\n* Adult patients, \\>/= 18 years of age\n* Diagnosis of rheumatoid arthritis according to American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) criteria\n* Patients who received at least one cycle of biologic therapy, either in monotherapy or in combination, in the 12 months preceding the opening of the first site\n\nPart 2:\n\n* Patients on monotherapy with RoActemra/Actemra already enrolled in Part 1 of the study\n\nExclusion Criteria:\n\n* Patients simultaneously participating in other studies with RoActemra/Actemra at the time of signing informed consent'}, 'identificationModule': {'nctId': 'NCT01791205', 'briefTitle': 'ARMONIA: An Observational Study of Biologic Drugs in Monotherapy or Combination With DMARDs in Italian Clinical Practice and the Efficacy and Safety of RoActemra/Actemra (Tocilizumab) Monotherapy in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multi-Center Observational Study on the Use of Biologic Drugs as Monotherapy or Combination With DMARDs in Patients With Rheumatoid Arthritis in Italian Clinical Practice (ARMONIA)', 'orgStudyIdInfo': {'id': 'ML28552'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Monotherapy', 'description': 'Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry will be observed for Phase I. Participants who were enrolled in Phase I and received tocilizumab (TCZ) as a monotherapy will be observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.'}, {'label': 'Combination Therapy', 'description': 'Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry will be observed for Phase I.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'state': 'Apulia', 'country': 'Italy', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '74015', 'city': 'Martina Franca', 'state': 'Apulia', 'country': 'Italy', 'geoPoint': {'lat': 40.70355, 'lon': 17.33814}}, {'zip': '89133', 'city': 'Reggio Calabria', 'state': 'Calabria', 'country': 'Italy', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '82037', 'city': 'Telese Terme', 'state': 'Campania', 'country': 'Italy', 'geoPoint': {'lat': 41.21752, 'lon': 14.52681}}, {'zip': '40138', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '00133', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00152', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00161', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00189', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '20025', 'city': 'Legnano', 'state': 'Lombardy', 'country': 'Italy', 'geoPoint': {'lat': 45.59788, 'lon': 8.91506}}, {'zip': '20157', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20162', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20052', 'city': 'Monza', 'state': 'Lombardy', 'country': 'Italy', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '27100', 'city': 'Pavia', 'state': 'Lombardy', 'country': 'Italy', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '10126', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '10128', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '07100', 'city': 'Sassari', 'state': 'Sardinia', 'country': 'Italy', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'zip': '60020', 'city': 'Ancona', 'state': 'The Marches', 'country': 'Italy', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '60035', 'city': 'Iesi', 'state': 'The Marches', 'country': 'Italy', 'geoPoint': {'lat': 43.52142, 'lon': 13.24368}}, {'zip': '50139', 'city': 'Florence', 'state': 'Tuscany', 'country': 'Italy', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '56100', 'city': 'Pisa', 'state': 'Tuscany', 'country': 'Italy', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '59100', 'city': 'Prato', 'state': 'Tuscany', 'country': 'Italy', 'geoPoint': {'lat': 43.8805, 'lon': 11.09699}}, {'zip': '53100', 'city': 'Siena', 'state': 'Tuscany', 'country': 'Italy', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '06122', 'city': 'Perugia', 'state': 'Umbria', 'country': 'Italy', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '44124', 'city': 'Cona (Ferrara)', 'state': 'Veneto', 'country': 'Italy', 'geoPoint': {'lat': 45.18388, 'lon': 12.01967}}, {'zip': '35128', 'city': 'Padua', 'state': 'Veneto', 'country': 'Italy', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '37126', 'city': 'Verona', 'state': 'Veneto', 'country': 'Italy', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}