Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT00870467
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2009-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Adalimumab in Japanese Subjects 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'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': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through Week 26 for all participants who received at least 1 dose of blinded study drug (adalimumab or placebo) or through Week 52 for participants who received any adalimumab (double-blind and/or open-label, including rescue) in addition to methotrexate.', 'description': 'Treatment-emergent adverse events were defined as occurring: 1) through Week 26 for Week 26 completers in blinded phase (or up to 70 days post-last dose for 26-week non-completers who never received any open-label adalimumab, including as rescue) and 2) through Week 52 for those receiving any adalimumab up to 70 days after the last adalimumab dose.', 'eventGroups': [{'id': 'EG000', 'title': 'DB Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.', 'otherNumAtRisk': 171, 'otherNumAffected': 104, 'seriousNumAtRisk': 171, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'DB Placebo', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.', 'otherNumAtRisk': 163, 'otherNumAffected': 83, 'seriousNumAtRisk': 163, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Any Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.', 'otherNumAtRisk': 326, 'otherNumAffected': 277, 'seriousNumAtRisk': 326, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 24}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 9}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 97}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumocystis jiroveci pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Facial spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Toxic skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Modified Total Sharp X-Ray Score at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '6.07', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '3.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 \\[no damage\\] to 5 \\[complete collapse or total destruction of joint\\]) and for joint space narrowing (0 \\[no damage\\] to 4 \\[complete luxation of joint\\]). Scores were added, giving total mTSS (0 \\[normal\\] to 380 \\[maximal disease\\]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Analysis performed using observed cases; no imputation technique used. Participants who switched to open-label adalimumab before Week 26 were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': "Patients were ACR20 responders if they had: \\>= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \\>=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': "Patients were ACR50 responders if they had: \\>= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \\>=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': "Patients were ACR70 responders if they had: \\>= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \\>=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': "Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Last observation carried forward (LOCF) was used for missing data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': "Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score \\<2.6 was defined as clinical remission of disease.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Week 26', 'description': 'Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of double-blind study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Total Sharp X-Ray Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab/OL Adalimumab', 'description': 'Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo/OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG002', 'title': 'DB Adalimumab/RE OL Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG003', 'title': 'DB Placebo/RE OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '6.50', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '3.25', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '11.76', 'groupId': 'OG002'}, {'value': '6.8', 'spread': '9.37', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 \\[no damage\\] to 5 \\[complete collapse or total destruction of joint\\]) and for joint space narrowing (0 \\[no damage\\] to 4 \\[complete luxation of joint\\]). Scores were added, giving total mTSS score (0 \\[normal\\] to 380 \\[maximal disease\\]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab/OL Adalimumab', 'description': 'Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo/OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG002', 'title': 'DB Adalimumab/RE OL Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG003', 'title': 'DB Placebo/RE OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "Patients were ACR20 responders if they had: \\>=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \\>=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab/OL Adalimumab', 'description': 'Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo/OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG002', 'title': 'DB Adalimumab/RE OL Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG003', 'title': 'DB Placebo/RE OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "Patients were ACR50 responders if they had: \\>=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \\>=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab/OL Adalimumab', 'description': 'Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo/OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG002', 'title': 'DB Adalimumab/RE OL Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG003', 'title': 'DB Placebo/RE OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "Patients were ACR70 responders if they had: \\>=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \\>=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab/OL Adalimumab', 'description': 'Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo/OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG002', 'title': 'DB Adalimumab/RE OL Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG003', 'title': 'DB Placebo/RE OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.7', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '1.58', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '1.22', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '1.29', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab/OL Adalimumab', 'description': 'Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG001', 'title': 'DB Placebo/OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG002', 'title': 'DB Adalimumab/RE OL Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'OG003', 'title': 'DB Placebo/RE OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score \\<2.6 was defined as clinical remission of disease.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '289', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Week 52', 'description': 'Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of adalimumab during the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DB Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'FG001', 'title': 'DB Placebo', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'FG002', 'title': 'DB Adalimumab/OL Adalimumab', 'description': 'Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'FG003', 'title': 'DB Placebo/OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'FG004', 'title': 'DB Adalimumab/RE OL Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'FG005', 'title': 'DB Placebo/RE OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.'}], 'periods': [{'title': 'Double-blind', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '163'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '10 participants who completed 26 weeks received open-label adalimumab 40 mg eow as rescue therapy', 'groupId': 'FG000', 'numSubjects': '155'}, {'comment': '24 participants who completed 26 weeks received open-label adalimumab 40 mg eow as rescue therapy', 'groupId': 'FG001', 'numSubjects': '151'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Open-label', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '145'}, {'groupId': 'FG003', 'numSubjects': '127'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '132'}, {'groupId': 'FG003', 'numSubjects': '120'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DB Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'BG001', 'title': 'DB Placebo', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.0', 'spread': '13.13', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '13.20', 'groupId': 'BG001'}, {'value': '54.0', 'spread': '13.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-01', 'studyFirstSubmitDate': '2009-03-26', 'resultsFirstSubmitDate': '2012-03-09', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-09', 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Modified Total Sharp X-Ray Score at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 \\[no damage\\] to 5 \\[complete collapse or total destruction of joint\\]) and for joint space narrowing (0 \\[no damage\\] to 4 \\[complete luxation of joint\\]). Scores were added, giving total mTSS (0 \\[normal\\] to 380 \\[maximal disease\\]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)', 'timeFrame': 'Week 26', 'description': "Patients were ACR20 responders if they had: \\>= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \\>=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders."}, {'measure': 'Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)', 'timeFrame': 'Week 26', 'description': "Patients were ACR50 responders if they had: \\>= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \\>=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders."}, {'measure': 'Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)', 'timeFrame': 'Week 26', 'description': "Patients were ACR70 responders if they had: \\>= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \\>=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders."}, {'measure': 'Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': "Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity."}, {'measure': 'Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26', 'timeFrame': 'Week 26', 'description': "Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score \\<2.6 was defined as clinical remission of disease."}, {'measure': 'Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26', 'timeFrame': 'Through Week 26', 'description': 'Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.'}, {'measure': 'Change From Baseline in Modified Total Sharp X-Ray Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 \\[no damage\\] to 5 \\[complete collapse or total destruction of joint\\]) and for joint space narrowing (0 \\[no damage\\] to 4 \\[complete luxation of joint\\]). Scores were added, giving total mTSS score (0 \\[normal\\] to 380 \\[maximal disease\\]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.'}, {'measure': 'Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)', 'timeFrame': 'Week 52', 'description': "Patients were ACR20 responders if they had: \\>=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \\>=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein."}, {'measure': 'Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)', 'timeFrame': 'Week 52', 'description': "Patients were ACR50 responders if they had: \\>=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \\>=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein."}, {'measure': 'Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)', 'timeFrame': 'Week 52', 'description': "Patients were ACR70 responders if they had: \\>=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \\>=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein."}, {'measure': 'Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity."}, {'measure': 'Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52', 'timeFrame': 'Week 52', 'description': "Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score \\<2.6 was defined as clinical remission of disease."}, {'measure': 'Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52', 'timeFrame': 'Through Week 52', 'description': 'Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details.'}]}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '27338778', 'type': 'DERIVED', 'citation': 'Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.'}, {'pmid': '24441150', 'type': 'DERIVED', 'citation': 'Yamanaka H, Ishiguro N, Takeuchi T, Miyasaka N, Mukai M, Matsubara T, Uchida S, Akama H, Kupper H, Arora V, Tanaka Y. Recovery of clinical but not radiographic outcomes by the delayed addition of adalimumab to methotrexate-treated Japanese patients with early rheumatoid arthritis: 52-week results of the HOPEFUL-1 trial. Rheumatology (Oxford). 2014 May;53(5):904-13. doi: 10.1093/rheumatology/ket465. Epub 2014 Jan 17.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.', 'detailedDescription': 'This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult Japanese patients with early rheumatoid arthritis (RA) who had not been previously treated with methotrexate (MTX). Eligible participants were randomized 1:1 to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week (eow) during the 26-week double-blind phase. All participants also received 6 mg to 8 mg MTX weekly as basal treatment for their disease. Participants who experienced an increase in disease activity (more than 20% increase in tender joint count and swollen joint count) at Week 12, 16, or 20 compared with Baseline after having increased MTX dose to 8 mg per week for at least 4 weeks were discontinued from the double-blind phase and were eligible to receive open-label adalimumab 40 mg eow as rescue treatment. Participants who completed the 26 weeks of treatment (either double-blind study drug \\[adalimumab or placebo\\] treatment or open-label adalimumab treatment) were eligible to enter the 26-week open-label phase in which they received adalimumab 40 mg eow. Efficacy and safety assessments were performed at Baseline and at designated study visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Rheumatoid arthritis based on the American College of Rheumatology criteria\n* Methotrexate or leflunomide naïve\n* Disease duration less than or equal to 2 years from diagnosis\n\nExclusion Criteria\n\n* History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV\n* Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus\n* Joint surgery involving joints to be assessed within 8 weeks prior to Screening'}, 'identificationModule': {'nctId': 'NCT00870467', 'briefTitle': 'A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'M06-859'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'DB Placebo', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.', 'interventionNames': ['Drug: Double-blind Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DB adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.', 'interventionNames': ['Biological: Double-blind adalimumab']}, {'type': 'EXPERIMENTAL', 'label': 'DB Adalimumab/OL Adalimumab', 'description': 'Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.', 'interventionNames': ['Biological: Double-blind adalimumab', 'Biological: Open-label Adalimumab']}, {'type': 'EXPERIMENTAL', 'label': 'DB Placebo/OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.', 'interventionNames': ['Drug: Double-blind Placebo', 'Biological: Open-label Adalimumab']}, {'type': 'EXPERIMENTAL', 'label': 'DB Adalimumab/RE OL Adalimumab', 'description': 'Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.', 'interventionNames': ['Biological: Double-blind adalimumab', 'Biological: Open-label Adalimumab', 'Biological: Open-labelAdalimumabRescue']}, {'type': 'EXPERIMENTAL', 'label': 'DB Placebo/RE OL Adalimumab', 'description': 'Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.', 'interventionNames': ['Drug: Double-blind Placebo', 'Biological: Open-label Adalimumab', 'Biological: Open-labelAdalimumabRescue']}], 'interventions': [{'name': 'Double-blind adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['ABT-D2E7, adalimumab, Humira'], 'description': 'Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)', 'armGroupLabels': ['DB Adalimumab/OL Adalimumab', 'DB Adalimumab/RE OL Adalimumab', 'DB adalimumab']}, {'name': 'Double-blind Placebo', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)', 'armGroupLabels': ['DB Placebo', 'DB Placebo/OL Adalimumab', 'DB Placebo/RE OL Adalimumab']}, {'name': 'Open-label Adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['ABT-D2E7', 'adalimumab', 'Humira'], 'description': 'Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study', 'armGroupLabels': ['DB Adalimumab/OL Adalimumab', 'DB Adalimumab/RE OL Adalimumab', 'DB Placebo/OL Adalimumab', 'DB Placebo/RE OL Adalimumab']}, {'name': 'Open-labelAdalimumabRescue', 'type': 'BIOLOGICAL', 'otherNames': ['ABT-D2E7', 'adalimumab', 'Humira'], 'description': 'Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26', 'armGroupLabels': ['DB Adalimumab/RE OL Adalimumab', 'DB Placebo/RE OL Adalimumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anjo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46861', 'geoPoint': {'lat': 34.95828, 'lon': 137.08054}}, {'city': 'Aomori', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46919', 'geoPoint': {'lat': 40.81667, 'lon': 140.73333}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46805', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46806', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46880', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46881', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fuchū', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46890', 'geoPoint': {'lat': 35.67452, 'lon': 139.48216}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46902', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46903', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46904', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Gifu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46856', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Gunma', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46944'}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46893', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46894', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 12161'}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46916'}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46918'}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46865', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46871', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46801', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46925', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46873', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46874', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46845', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46899', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46901', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kanazawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46851', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Kanazawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46852', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Kawagoe', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46802', 'geoPoint': {'lat': 35.90861, 'lon': 139.48528}}, {'city': 'Kawasaki', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46900', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Kirishima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46875', 'geoPoint': {'lat': 31.74087, 'lon': 130.76288}}, {'city': 'Kitakyushu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46870', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46872', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46912', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46864', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Maebashi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46943', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Matsuyama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46898', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Miyazaki', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46915', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'city': 'Nagano', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46853', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Nagano', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46855', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46909', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46910', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46911', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46858', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46860', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nara', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46877', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'city': 'Nara', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46885', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'city': 'Niigata', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46848', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Niigata', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46906', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Numakunai', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46800', 'geoPoint': {'lat': 39.96667, 'lon': 141.21667}}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46869', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46886', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46887', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46892', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okinawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46876', 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46946', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46947', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Ōita', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46914', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Rifu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46842', 'geoPoint': {'lat': 38.33092, 'lon': 140.97691}}, {'city': 'Sagamihara', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46846', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46803', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46804', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46878', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46879', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46917', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Shimotsuke', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46942', 'geoPoint': {'lat': 36.41323, 'lon': 139.86622}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46854', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46857', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46859', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Takamatsu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46895', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46843', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46844', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46850', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46882', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46883', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46884', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46888', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46889', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46891', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46896', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Toyama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46849', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Toyama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46907', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Toyoake', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46862', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'city': 'Toyohashi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46866', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'city': 'Tsu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46863', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'city': 'Tsukuba', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46926', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'city': 'Yokohama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46897', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokohama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 46905', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Hiroshi Ukai, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Japan Co.,Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}