Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 3:40 PM
Study NCT ID:
NCT00845832
Status:
TERMINATED
Last Update Posted:
2014-12-24
First Post:
2009-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C502936', 'term': 'tocilizumab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '1-800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann- LaRoche'}, 'certainAgreement': {'otherDetails': "The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were recorded throughout the study from the date of first study drug administration until 48 weeks of treatment period and for those in the Safety follow up population until the end of follow up period.', 'description': 'Participants who received the incorrect therapy from that intended were summarized in the group according to the therapy actually received for the majority of the time through Week 48. 1 participant each from Placebo + TCZ (8 mg/kg) and Rituximab (0.5 g) + TCZ (2 mg/kg) groups was included in Rituximab (0.5 g) + TCZ (4 mg/kg) group.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.', 'otherNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Infected bites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Ligamentitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Tenosynovitis stenosans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Intertrigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Essential tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Occipital neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Allergic bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Corneal erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Presbyopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Genital ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Seasonal Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Occipital Neuralgia (left)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Occipital Neuralgia (right)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Anxiety Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cervix Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Tooth Ache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Large intestinal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Low Disease Activity (LDA) at Week 16 Assessed Using Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "The Disease Activity Score based on 28 joint count (DAS28) and Erythrocyte Sedimentation Rate (ESR), is a measure of the participant's disease activity. It is based on the Tender Joint Count (TJC \\[28 joints\\]), Swollen Joint Count (SJC \\[28 joints\\]), participant's global assessment of disease activity (PtGA) Visual Analog Scale (VAS) in millimeters (mm), and ESR in millimeters per hour (mm/hour). DAS28-ESR scores range from 0 - 10. Definition of LDA was based on DAS28-ESR scores. To achieve LDA the DAS28-ESR had to be (less than or equal to) ≤ 3.2.\n\nDAS28-ESR equals (=) (0.56 times (\\*) (square root)√ TJC plus (+) (0.28 \\* √ SJC + (0.70 \\* ln(ESR))+(0.014 \\* (Global Health) GH)\n\nWhere:\n\nTJC = based on 28 joints SJC = based on 28 joints ESR = erythrocyte sedimentation rate in mm/hour GH = participant's global assessment of disease activity ln = natural log", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all randomized participants who received any part of an infusion of study medication. Last observation carried forward (LOCF) used for TJC and SJC, ESR and PtGA. If DAS28-ESR value was missing LDA was missing.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Remission at Week 16 Assessed Using DAS28-ESR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR less than (\\<) 2.6", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; LOCF used for TJC, ESR, and PtGA. If the DAS28-ESR value was missing then remission or LDA was missing.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants by European League Against Rheumatism (EULAR) Response Category at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'classes': [{'title': 'No Response', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}, {'value': '11.1', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Response', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}, {'title': 'Good Response', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '22.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline (greater than) \\>1.2 with DAS28 ≤3.2; moderate responders: change from baseline \\>1.2 with DAS28 \\>3.2 to ≤5.1 or DAS28-ESR \\>5.1 or change from baseline \\>0.6 to ≤1.2 with DAS28 ≤5.1; nonresponders: change from baseline ≤0.6 or change from baseline \\>0.6 and ≤1.2 with DAS28 \\>5.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; No imputation used for TJC, SJC, ESR, and PtGA. EULAR response was set to missing when the DAS28 score was missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DAS28-ESR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'classes': [{'title': 'Week 4 (n=4,9,10)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.72', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=4,10,10)', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (n=4,10,9)', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '1.36', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 (n=4,9,9)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 (n=4,9,9)', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '1.45', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 (n=4,9,8)', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 (n=4,9,8)', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '1.92', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '1.83', 'groupId': 'OG002'}]}]}, {'title': 'Week 40 (n=3,8,8)', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '1.63', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '1.02', 'groupId': 'OG002'}]}]}, {'title': 'Week 48 (n=4,8,7)', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '1.50', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '1.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48', 'description': "The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst).\n\nDAS28-ESR scores were calculated as follows: DAS28-ESR = (0.56 \\* √TJC)+(0.28 \\* √SJC)+(0.70 \\* ln(ESR))+(0.014 \\* GH).\n\nNo imputation used for tender and swollen joint counts, ESR, and patient's global assessment of disease activity VAS.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; number (n) = number of participants analyzed at the specified visit.'}, {'type': 'SECONDARY', 'title': 'Clinical Disease Activity Index Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'classes': [{'title': 'Baseline (n=4, 10, 10)', 'categories': [{'measurements': [{'value': '37.7', 'spread': '4.59', 'groupId': 'OG000'}, {'value': '36.4', 'spread': '9.16', 'groupId': 'OG001'}, {'value': '33.0', 'spread': '7.69', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 (n=4, 8, 10)', 'categories': [{'measurements': [{'value': '21.2', 'spread': '14.19', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '12.38', 'groupId': 'OG001'}, {'value': '20.0', 'spread': '6.97', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=4,10,10)', 'categories': [{'measurements': [{'value': '14.6', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '14.91', 'groupId': 'OG001'}, {'value': '15.5', 'spread': '9.96', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (n=4,10, 9)', 'categories': [{'measurements': [{'value': '16.3', 'spread': '10.52', 'groupId': 'OG000'}, {'value': '23.2', 'spread': '12.47', 'groupId': 'OG001'}, {'value': '13.4', 'spread': '8.40', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 (n=4,10, 9)', 'categories': [{'measurements': [{'value': '9.5', 'spread': '5.70', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '15.42', 'groupId': 'OG001'}, {'value': '12.7', 'spread': '8.32', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 (n=4, 8, 9)', 'categories': [{'measurements': [{'value': '10.8', 'spread': '4.46', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '7.76', 'groupId': 'OG001'}, {'value': '11.6', 'spread': '6.64', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 (n=4, 9, 8)', 'categories': [{'measurements': [{'value': '9.2', 'spread': '6.71', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '3.98', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '5.47', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 (n=4, 9, 8)', 'categories': [{'measurements': [{'value': '15.2', 'spread': '10.42', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '13.14', 'groupId': 'OG001'}, {'value': '9.3', 'spread': '9.42', 'groupId': 'OG002'}]}]}, {'title': 'Week 40 (n=3, 8, 8)', 'categories': [{'measurements': [{'value': '20.3', 'spread': '8.35', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '16.40', 'groupId': 'OG001'}, {'value': '11.8', 'spread': '5.31', 'groupId': 'OG002'}]}]}, {'title': 'Week 48 (n=4, 7, 8)', 'categories': [{'measurements': [{'value': '11.6', 'spread': '10.11', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '12.15', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '6.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48', 'description': "The Clinical Disease Activity Index (CDAI) score was calculated according to the following formula: CDAI = SJC + TJC + GH/10 + EGA/10\n\nWhere:\n\nSJC = swollen joint count based on 28 joints; TJC = tender joint count based on 28 joints; GH = Participant's global assessment of disease activity; EGA = evaluator's (physician's) global assessment of disease activity. CDAI scores range from 0-76 and the following cut-off points for different disease activity states have been used: high disease activity \\>22; moderate disease activity \\>10 and ≤22; LDA \\>2.8 and ≤10; and remission ≤ 2.8. No imputation used for TJC, SJC, Patient's Global Assessment of Disease Activity VAS and Physicians global assessment of disease activity VAS.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Simplified Disease Activity Index (SDAI) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48', 'description': 'The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), Participant and Physician assessed global disease activity (assessed on 0-100 mm VAS; higher scores = greater affection due to disease activity), and ESR (mm/hour). SDAI total score ranged from 0 to 86. Higher scores indicated greater disease activity.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected because the study was terminated early.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 48 in SJC and TJC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'timeFrame': 'Baseline and Week 48', 'description': 'An assessment of 28 joints for swelling and tenderness will be made. Joints will be assessed and classified as swollen (1)/not swollen (0) and tender(1)/not tender (0) by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. The 28 joints assessed comprise shoulders (2 joints), elbows (2 joints), wrists (2 joints), metacarpophalangeal joints on digits 1-5 (10 joints), interphalangeal on digit 1 (2 joints), proximal interphalangeal joints on digits 2-5 (8 joints), and knees (2 joints).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected because the study was terminated early.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 48 in Health Assessment Questionnaire (HAQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'timeFrame': 'Baseline and Week 48', 'description': 'The Stanford Health Assessment Questionnaire disability index specific for rheumatoid arthritis was completed by the participants for efficacy assessments.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected because the study was terminated early.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 48 in C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'timeFrame': 'Baseline and Week 48', 'description': 'CRP is an acute phase reactant and is a measure of inflammation.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected because the study was terminated early.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 48 in ESR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'timeFrame': 'Baseline and Week 48', 'description': 'ESR is an acute phase reactant and is a measure of inflammation.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected because the study was terminated early.'}, {'type': 'SECONDARY', 'title': "Change From Baseline to Week 48 in Physician's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'timeFrame': 'Baseline and Week 48', 'description': 'Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm= maximum disease activity. The physician marked the line according to their assessment and the distance from the left edge was measured.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected because the study was terminated early.'}, {'type': 'SECONDARY', 'title': "Change From Baseline to Week 48 in Participant's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'timeFrame': 'Baseline and Week 48', 'description': "Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = maximum disease activity. The participant marked the line according to their assessment and the distance from the left edge was measured.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected because the study was terminated early.'}, {'type': 'SECONDARY', 'title': "Change From Baseline to Week 48 in Participant's Assessment of Pain", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'OG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'timeFrame': 'Baseline and Week 48', 'description': "Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no pain and 100 mm = maximum pain. The participant marked the line according to their assessment and the distance from the left edge was measured.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected because the study was terminated early.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)', 'description': 'Participants received placebo intravenously (iv) on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'FG001', 'title': 'Rituximab (0.5 Grams [g]) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'FG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Safety Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant from this group was re-assigned to TCZ (4 mg/kg) group.', 'groupId': 'FG000', 'numSubjects': '3'}, {'comment': 'All participants who withdrew from study were asked to return for safety follow-up.', 'groupId': 'FG001', 'numSubjects': '9'}, {'comment': 'One participant each from the placebo and TCZ (2 mg/kg) groups were re-assigned to this group.', 'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'comment': 'One participant from this group was re-assigned to TCZ (4 mg/kg) group.', 'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Extended Safety Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'comment': 'Only participants who remained B cell depleted required extended safety follow-up.', 'groupId': 'FG001', 'numSubjects': '5'}, {'comment': 'Only participants who remained B cell depleted required extended safety follow-up.', 'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + TCZ (8 mg/kg)', 'description': 'Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'BG001', 'title': 'Rituximab (0.5 g) + TCZ (2 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'BG002', 'title': 'Rituximab (0.5 g) + TCZ (4 mg/kg)', 'description': 'Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'spread': '11.02', 'groupId': 'BG000'}, {'value': '48.2', 'spread': '10.50', 'groupId': 'BG001'}, {'value': '50.0', 'spread': '6.97', 'groupId': 'BG002'}, {'value': '48.3', 'spread': '8.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population: All participants who were randomized and received any part of an infusion of study medication; participants who received the incorrect therapy from that intended were summarized in the group according to the therapy actually received for the majority of the time through Week 48.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'The study was terminated early because of a related decision to stop the development of ocrelizumab in rheumatoid arthritis.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-15', 'studyFirstSubmitDate': '2009-02-17', 'resultsFirstSubmitDate': '2014-06-23', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-15', 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Low Disease Activity (LDA) at Week 16 Assessed Using Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)', 'timeFrame': 'Week 16', 'description': "The Disease Activity Score based on 28 joint count (DAS28) and Erythrocyte Sedimentation Rate (ESR), is a measure of the participant's disease activity. It is based on the Tender Joint Count (TJC \\[28 joints\\]), Swollen Joint Count (SJC \\[28 joints\\]), participant's global assessment of disease activity (PtGA) Visual Analog Scale (VAS) in millimeters (mm), and ESR in millimeters per hour (mm/hour). DAS28-ESR scores range from 0 - 10. Definition of LDA was based on DAS28-ESR scores. To achieve LDA the DAS28-ESR had to be (less than or equal to) ≤ 3.2.\n\nDAS28-ESR equals (=) (0.56 times (\\*) (square root)√ TJC plus (+) (0.28 \\* √ SJC + (0.70 \\* ln(ESR))+(0.014 \\* (Global Health) GH)\n\nWhere:\n\nTJC = based on 28 joints SJC = based on 28 joints ESR = erythrocyte sedimentation rate in mm/hour GH = participant's global assessment of disease activity ln = natural log"}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Remission at Week 16 Assessed Using DAS28-ESR', 'timeFrame': 'Week 16', 'description': "The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR less than (\\<) 2.6"}, {'measure': 'Percentage of Participants by European League Against Rheumatism (EULAR) Response Category at Week 16', 'timeFrame': 'Week 16', 'description': 'DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline (greater than) \\>1.2 with DAS28 ≤3.2; moderate responders: change from baseline \\>1.2 with DAS28 \\>3.2 to ≤5.1 or DAS28-ESR \\>5.1 or change from baseline \\>0.6 to ≤1.2 with DAS28 ≤5.1; nonresponders: change from baseline ≤0.6 or change from baseline \\>0.6 and ≤1.2 with DAS28 \\>5.1.'}, {'measure': 'Change From Baseline in DAS28-ESR', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48', 'description': "The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst).\n\nDAS28-ESR scores were calculated as follows: DAS28-ESR = (0.56 \\* √TJC)+(0.28 \\* √SJC)+(0.70 \\* ln(ESR))+(0.014 \\* GH).\n\nNo imputation used for tender and swollen joint counts, ESR, and patient's global assessment of disease activity VAS."}, {'measure': 'Clinical Disease Activity Index Scores', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48', 'description': "The Clinical Disease Activity Index (CDAI) score was calculated according to the following formula: CDAI = SJC + TJC + GH/10 + EGA/10\n\nWhere:\n\nSJC = swollen joint count based on 28 joints; TJC = tender joint count based on 28 joints; GH = Participant's global assessment of disease activity; EGA = evaluator's (physician's) global assessment of disease activity. CDAI scores range from 0-76 and the following cut-off points for different disease activity states have been used: high disease activity \\>22; moderate disease activity \\>10 and ≤22; LDA \\>2.8 and ≤10; and remission ≤ 2.8. No imputation used for TJC, SJC, Patient's Global Assessment of Disease Activity VAS and Physicians global assessment of disease activity VAS."}, {'measure': 'Simplified Disease Activity Index (SDAI) Scores', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48', 'description': 'The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), Participant and Physician assessed global disease activity (assessed on 0-100 mm VAS; higher scores = greater affection due to disease activity), and ESR (mm/hour). SDAI total score ranged from 0 to 86. Higher scores indicated greater disease activity.'}, {'measure': 'Change From Baseline to Week 48 in SJC and TJC', 'timeFrame': 'Baseline and Week 48', 'description': 'An assessment of 28 joints for swelling and tenderness will be made. Joints will be assessed and classified as swollen (1)/not swollen (0) and tender(1)/not tender (0) by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. The 28 joints assessed comprise shoulders (2 joints), elbows (2 joints), wrists (2 joints), metacarpophalangeal joints on digits 1-5 (10 joints), interphalangeal on digit 1 (2 joints), proximal interphalangeal joints on digits 2-5 (8 joints), and knees (2 joints).'}, {'measure': 'Change From Baseline to Week 48 in Health Assessment Questionnaire (HAQ)', 'timeFrame': 'Baseline and Week 48', 'description': 'The Stanford Health Assessment Questionnaire disability index specific for rheumatoid arthritis was completed by the participants for efficacy assessments.'}, {'measure': 'Change From Baseline to Week 48 in C-Reactive Protein (CRP)', 'timeFrame': 'Baseline and Week 48', 'description': 'CRP is an acute phase reactant and is a measure of inflammation.'}, {'measure': 'Change From Baseline to Week 48 in ESR', 'timeFrame': 'Baseline and Week 48', 'description': 'ESR is an acute phase reactant and is a measure of inflammation.'}, {'measure': "Change From Baseline to Week 48 in Physician's Global Assessment of Disease Activity", 'timeFrame': 'Baseline and Week 48', 'description': 'Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm= maximum disease activity. The physician marked the line according to their assessment and the distance from the left edge was measured.'}, {'measure': "Change From Baseline to Week 48 in Participant's Global Assessment of Disease Activity", 'timeFrame': 'Baseline and Week 48', 'description': "Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = maximum disease activity. The participant marked the line according to their assessment and the distance from the left edge was measured."}, {'measure': "Change From Baseline to Week 48 in Participant's Assessment of Pain", 'timeFrame': 'Baseline and Week 48', 'description': "Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no pain and 100 mm = maximum pain. The participant marked the line according to their assessment and the distance from the left edge was measured."}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose of methotrexate. In Part 1 of the study, patients will be randomized to receive either MabThera 0.5g iv or placebo on days 1 and 15, follo wed by RoActemra at one of the ascending doses between 2mg/kg and 8mg/kg at week s 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm). In Part 2, additional pati ents will be randomized to one of 2 groups to receive MabThera 0.5g on days 1 an d 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8 and 1 2, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8 and 12.\n\nAll patients will then be eligible to receive extension treatment withRoActemra every 4 weeks. The anticipated time on study treatment is 12 months, and the tar get sample size is \\<100 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, 18-65 years of age;\n* rheumatoid arthritis, functional status I-III;\n* SJC\\>=4 (28 joint count) and TJC\\>=4 (28 joint count) at screening and baseline;\n* RF and/or anti-CCP positive;\n* may have failed up to 1 approved anti-TNF agent (infliximab, etanercept or adalimumab);\n* inadequate response to methotrexate, at a dose of 7.5-25mg weekly for at least 12 weeks, at a stable dose for past 4 weeks.\n\nExclusion Criteria:\n\n* rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic involvement secondary to rheumatoid arthritis;\n* history of, or current, inflammatory joint disease other than rheumatoid arthritis;\n* diagnosis of juvenile idiopathic arthritis and/or rheumatoid arthritis before age 16;\n* significant cardiac or pulmonary disease;\n* previous treatment with any biologic agent for rheumatoid arthritis (other than infliximab, etanercept or adalimumab).'}, 'identificationModule': {'nctId': 'NCT00845832', 'briefTitle': 'A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to Methotrexate', 'orgStudyIdInfo': {'id': 'WX21956'}, 'secondaryIdInfos': [{'id': '2008-005525-11'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: rituximab [MabThera/Rituxan]', 'Drug: tocilizumab [RoActemra/Actemra]']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo', 'Drug: tocilizumab [RoActemra/Actemra]']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'iv on days 1 and 15 (Parts 1 and 2)', 'armGroupLabels': ['2']}, {'name': 'rituximab [MabThera/Rituxan]', 'type': 'DRUG', 'description': '0.5g iv on days 1 and 15 (Parts 1 and 2)', 'armGroupLabels': ['1']}, {'name': 'tocilizumab [RoActemra/Actemra]', 'type': 'DRUG', 'description': '2mg/kg-8mg/kg iv in Part 1 and selected dose in Part 2, on weeks 4, 8 and 12---Arm 1\\\\n8mg/kg iv on weeks 4,8 and 12 (Parts 1 and 2)--- Arm 2', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14059', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '15121', 'city': 'Athens', 'country': 'Greece', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '54636', 'city': 'Thessaloniki', 'country': 'Greece', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '41-902', 'city': 'Bytom', 'country': 'Poland', 'geoPoint': {'lat': 50.34802, 'lon': 18.93282}}, {'zip': '20-607', 'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '60-218', 'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'La Coruña', 'country': 'Spain', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '28007', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41009', 'city': 'Seville', 'state': 'Sevilla', 'country': 'Spain', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}