Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT01877668
Status:
COMPLETED
Last Update Posted:
2017-07-06
First Post:
2013-06-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}, {'id': 'C494814', 'term': 'BID protein, human'}, {'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': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.', 'otherNumAtRisk': 107, 'otherNumAffected': 31, 'seriousNumAtRisk': 107, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.', 'otherNumAtRisk': 104, 'otherNumAffected': 43, 'seriousNumAtRisk': 104, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.', 'otherNumAtRisk': 106, 'otherNumAffected': 43, 'seriousNumAtRisk': 106, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.', 'otherNumAtRisk': 52, 'otherNumAffected': 15, 'seriousNumAtRisk': 52, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks', 'otherNumAtRisk': 53, 'otherNumAffected': 22, 'seriousNumAtRisk': 53, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Blood 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107, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 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'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Pyoderma streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 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'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.47', 'groupId': 'OG000'}, {'value': '60.58', 'groupId': 'OG001'}, {'value': '51.89', 'groupId': 'OG002'}, {'value': '33.33', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0102', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.13', 'ciLowerLimit': '4.06', 'ciUpperLimit': '30.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.67', 'statisticalMethod': 'Large sample approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing response (MR)=non-response (NR)'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.24', 'ciLowerLimit': '14.22', 'ciUpperLimit': '40.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.64', 'statisticalMethod': 'Large sample approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MR=NR'}, {'pValue': '0.0055', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.55', 'ciLowerLimit': '5.45', 'ciUpperLimit': '31.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.69', 'statisticalMethod': 'Large sample approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'MR=NR'}], 'paramType': 'NUMBER', 'timeFrame': 'At end of Month 3', 'description': "ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).", 'unitOfMeasure': 'Percentage or participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3499', 'spread': '0.04665', 'groupId': 'OG000'}, {'value': '-0.3998', 'spread': '0.04716', 'groupId': 'OG001'}, {'value': '-0.3808', 'spread': '0.04767', 'groupId': 'OG002'}, {'value': '-0.1802', 'spread': '0.05031', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0062', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1697', 'ciLowerLimit': '-0.2910', 'ciUpperLimit': '-0.0483', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06173', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No imputation.'}, {'pValue': '0.0004', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2196', 'ciLowerLimit': '-0.3411', 'ciUpperLimit': '-0.0980', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06184', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No imputation.'}, {'pValue': '0.0012', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2005', 'ciLowerLimit': '-0.3213', 'ciUpperLimit': '-0.0797', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06145', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No imputation.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Month 3', 'description': 'The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.067', 'groupId': 'OG001'}, {'value': '-0.07', 'spread': '0.069', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.094', 'groupId': 'OG003'}, {'value': '0.09', 'spread': '0.099', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Month 12', 'description': 'Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.08', 'groupId': 'OG000'}, {'value': '5.05', 'groupId': 'OG001'}, {'value': '2.11', 'groupId': 'OG002'}, {'value': '4.17', 'groupId': 'OG003'}, {'value': '8.89', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 12', 'description': 'Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS \\>0.5 from baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Week 2 (n=7, 7, 5, NA, NA, 1)', 'categories': [{'measurements': [{'value': '6.54', 'groupId': 'OG000'}, {'value': '6.73', 'groupId': 'OG001'}, {'value': '4.72', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '0.95', 'groupId': 'OG005'}]}]}, {'title': 'Month 1 (n=13, 20,12, NA, NA, 5)', 'categories': [{'measurements': [{'value': '12.15', 'groupId': 'OG000'}, {'value': '19.23', 'groupId': 'OG001'}, {'value': '11.32', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '4.76', 'groupId': 'OG005'}]}]}, {'title': 'Month 2 (n=23, 34, 24, NA, NA, 8)', 'categories': [{'measurements': [{'value': '21.50', 'groupId': 'OG000'}, {'value': '32.69', 'groupId': 'OG001'}, {'value': '22.64', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '7.62', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=30, 42, 35, NA, NA, 10)', 'categories': [{'measurements': [{'value': '28.04', 'groupId': 'OG000'}, {'value': '40.38', 'groupId': 'OG001'}, {'value': '33.02', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '9.52', 'groupId': 'OG005'}]}]}, {'title': 'Month 4 (n=38, 39, 34, 11, 17, NA)', 'categories': [{'measurements': [{'value': '35.51', 'groupId': 'OG000'}, {'value': '37.50', 'groupId': 'OG001'}, {'value': '32.08', 'groupId': 'OG002'}, {'value': '21.15', 'groupId': 'OG003'}, {'value': '32.08', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=41, 48, 45, 17, 14, NA)', 'categories': [{'measurements': [{'value': '38.32', 'groupId': 'OG000'}, {'value': '46.15', 'groupId': 'OG001'}, {'value': '42.45', 'groupId': 'OG002'}, {'value': '32.69', 'groupId': 'OG003'}, {'value': '26.42', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=45, 48, 49, 22, 23, NA)', 'categories': [{'measurements': [{'value': '42.06', 'groupId': 'OG000'}, {'value': '46.15', 'groupId': 'OG001'}, {'value': '46.23', 'groupId': 'OG002'}, {'value': '42.31', 'groupId': 'OG003'}, {'value': '43.40', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=48, 50, 43, 21, 19, NA)', 'categories': [{'measurements': [{'value': '44.86', 'groupId': 'OG000'}, {'value': '48.08', 'groupId': 'OG001'}, {'value': '40.57', 'groupId': 'OG002'}, {'value': '40.38', 'groupId': 'OG003'}, {'value': '35.85', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12', 'description': "ACR50 was calculated as a ≥50% improvement from baseline in tender/painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug. n=number of responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Week 2 (n=0, 3, 1, NA, NA, 0)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '2.88', 'groupId': 'OG001'}, {'value': '0.94', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '0.00', 'groupId': 'OG005'}]}]}, {'title': 'Month 1 (n=5, 8, 4, NA, NA, 1)', 'categories': [{'measurements': [{'value': '4.67', 'groupId': 'OG000'}, {'value': '7.69', 'groupId': 'OG001'}, {'value': '3.77', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '0.95', 'groupId': 'OG005'}]}]}, {'title': 'Month 2 (n=10, 14, 13, NA, NA, 2)', 'categories': [{'measurements': [{'value': '9.35', 'groupId': 'OG000'}, {'value': '13.46', 'groupId': 'OG001'}, {'value': '12.26', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '1.90', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=18, 15, 20, NA, NA, 5)', 'categories': [{'measurements': [{'value': '16.82', 'groupId': 'OG000'}, {'value': '14.42', 'groupId': 'OG001'}, {'value': '18.87', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '4.76', 'groupId': 'OG005'}]}]}, {'title': 'Month 4 (n=24, 23, 21, 7, 8, NA)', 'categories': [{'measurements': [{'value': '22.43', 'groupId': 'OG000'}, {'value': '22.12', 'groupId': 'OG001'}, {'value': '19.81', 'groupId': 'OG002'}, {'value': '13.46', 'groupId': 'OG003'}, {'value': '15.09', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=19, 33, 32, 10, 7, NA)', 'categories': [{'measurements': [{'value': '17.76', 'groupId': 'OG000'}, {'value': '31.73', 'groupId': 'OG001'}, {'value': '30.19', 'groupId': 'OG002'}, {'value': '19.23', 'groupId': 'OG003'}, {'value': '13.21', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=21, 31, 30, 15, 12, NA)', 'categories': [{'measurements': [{'value': '19.63', 'groupId': 'OG000'}, {'value': '29.81', 'groupId': 'OG001'}, {'value': '28.30', 'groupId': 'OG002'}, {'value': '28.85', 'groupId': 'OG003'}, {'value': '22.64', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=25, 32, 31, 12, 12, NA)', 'categories': [{'measurements': [{'value': '23.36', 'groupId': 'OG000'}, {'value': '30.77', 'groupId': 'OG001'}, {'value': '29.25', 'groupId': 'OG002'}, {'value': '23.08', 'groupId': 'OG003'}, {'value': '22.64', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12', 'description': "ACR70 was calculated as a ≥70% improvement from baseline in tender/painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.\n\n.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug. n=number of responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Week 2 (n=24, 33, 23, NA, NA, 6)', 'categories': [{'measurements': [{'value': '22.43', 'groupId': 'OG000'}, {'value': '31.73', 'groupId': 'OG001'}, {'value': '21.70', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '5.71', 'groupId': 'OG005'}]}]}, {'title': 'Month 1 (n=37, 50, 30, NA, NA, 11)', 'categories': [{'measurements': [{'value': '34.58', 'groupId': 'OG000'}, {'value': '48.08', 'groupId': 'OG001'}, {'value': '28.30', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '10.48', 'groupId': 'OG005'}]}]}, {'title': 'Month 2 (n=47, 57, 62, NA, NA, 28)', 'categories': [{'measurements': [{'value': '43.93', 'groupId': 'OG000'}, {'value': '54.81', 'groupId': 'OG001'}, {'value': '58.49', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '26.67', 'groupId': 'OG005'}]}]}, {'title': 'Month 4 (n=65, 60, 61, 27, 28, NA)', 'categories': [{'measurements': [{'value': '60.75', 'groupId': 'OG000'}, {'value': '57.69', 'groupId': 'OG001'}, {'value': '57.55', 'groupId': 'OG002'}, {'value': '51.92', 'groupId': 'OG003'}, {'value': '52.83', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=63, 70, 68, 31, 30, NA)', 'categories': [{'measurements': [{'value': '58.88', 'groupId': 'OG000'}, {'value': '67.31', 'groupId': 'OG001'}, {'value': '64.15', 'groupId': 'OG002'}, {'value': '59.62', 'groupId': 'OG003'}, {'value': '56.60', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=73, 76, 73, 35, 37, NA)', 'categories': [{'measurements': [{'value': '68.22', 'groupId': 'OG000'}, {'value': '73.08', 'groupId': 'OG001'}, {'value': '68.87', 'groupId': 'OG002'}, {'value': '67.31', 'groupId': 'OG003'}, {'value': '69.81', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=73, 73, 64, 35, 31, NA)', 'categories': [{'measurements': [{'value': '68.22', 'groupId': 'OG000'}, {'value': '70.19', 'groupId': 'OG001'}, {'value': '60.38', 'groupId': 'OG002'}, {'value': '67.31', 'groupId': 'OG003'}, {'value': '58.49', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2 and Months 1, 2, 4, 6, 9, and 12', 'description': "ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug. n=number of responders.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Week 2 (n=106, 102, 103, NA, NA, 102)', 'categories': [{'measurements': [{'value': '-0.1842', 'spread': '0.04131', 'groupId': 'OG000'}, {'value': '-0.2089', 'spread': '0.04208', 'groupId': 'OG001'}, {'value': '-0.2129', 'spread': '0.04246', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.0837', 'spread': '0.04549', 'groupId': 'OG005'}]}]}, {'title': 'Month 1 (n=105, 103, 104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '-0.2048', 'spread': '0.04363', 'groupId': 'OG000'}, {'value': '-0.2676', 'spread': '0.04426', 'groupId': 'OG001'}, {'value': '-0.3028', 'spread': '0.04465', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.1224', 'spread': '0.04755', 'groupId': 'OG005'}]}]}, {'title': 'Month 2 (n=104, 104, 104, NA, NA, 102)', 'categories': [{'measurements': [{'value': '-0.2713', 'spread': '0.04626', 'groupId': 'OG000'}, {'value': '-0.4009', 'spread': '0.04678', 'groupId': 'OG001'}, {'value': '-0.3736', 'spread': '0.04719', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.1682', 'spread': '0.04998', 'groupId': 'OG005'}]}]}, {'title': 'Month 4 (n=102, 100, 102, 50, 50, NA)', 'categories': [{'measurements': [{'value': '-0.4231', 'spread': '0.04982', 'groupId': 'OG000'}, {'value': '-0.4407', 'spread': '0.05039', 'groupId': 'OG001'}, {'value': '-0.3643', 'spread': '0.05069', 'groupId': 'OG002'}, {'value': '-0.2850', 'spread': '0.07075', 'groupId': 'OG003'}, {'value': '-0.3302', 'spread': '0.07128', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '-0.4471', 'spread': '0.05136', 'groupId': 'OG000'}, {'value': '-0.4611', 'spread': '0.05179', 'groupId': 'OG001'}, {'value': '-0.4259', 'spread': '0.05227', 'groupId': 'OG002'}, {'value': '-0.3142', 'spread': '0.07315', 'groupId': 'OG003'}, {'value': '-0.3841', 'spread': '0.07369', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 96, 96, 47, 45, NA)', 'categories': [{'measurements': [{'value': '-0.5119', 'spread': '0.05038', 'groupId': 'OG000'}, {'value': '-0.4847', 'spread': '0.05096', 'groupId': 'OG001'}, {'value': '-0.4304', 'spread': '0.05143', 'groupId': 'OG002'}, {'value': '-0.3843', 'spread': '0.07185', 'groupId': 'OG003'}, {'value': '-0.4839', 'spread': '0.07276', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '-0.5391', 'spread': '0.05324', 'groupId': 'OG000'}, {'value': '-0.5104', 'spread': '0.05365', 'groupId': 'OG001'}, {'value': '-0.4478', 'spread': '0.05426', 'groupId': 'OG002'}, {'value': '-0.4104', 'spread': '0.07646', 'groupId': 'OG003'}, {'value': '-0.4569', 'spread': '0.07704', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12', 'description': 'The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5981', 'spread': '0.80656', 'groupId': 'OG000'}, {'value': '-6.6004', 'spread': '0.80822', 'groupId': 'OG001'}, {'value': '-7.8955', 'spread': '0.82547', 'groupId': 'OG002'}, {'value': '-0.8643', 'spread': '0.86304', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to end of Month 3', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain", 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.49', 'spread': '2.325', 'groupId': 'OG000'}, {'value': '-27.10', 'spread': '2.342', 'groupId': 'OG001'}, {'value': '-21.87', 'spread': '2.389', 'groupId': 'OG002'}, {'value': '-10.22', 'spread': '2.499', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to end of Month 3', 'description': 'Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis", 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.08', 'spread': '2.275', 'groupId': 'OG000'}, {'value': '-25.50', 'spread': '2.291', 'groupId': 'OG001'}, {'value': '-21.47', 'spread': '2.328', 'groupId': 'OG002'}, {'value': '-11.40', 'spread': '2.439', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to end of Month 3', 'description': 'Participant answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant\'s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis", 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.44', 'spread': '1.998', 'groupId': 'OG000'}, {'value': '-33.74', 'spread': '2.021', 'groupId': 'OG001'}, {'value': '-29.02', 'spread': '2.043', 'groupId': 'OG002'}, {'value': '-22.26', 'spread': '2.121', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to end of Month 3', 'description': "The blinded investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.5', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-6.5', 'spread': '0.59', 'groupId': 'OG002'}, {'value': '-4.8', 'spread': '0.62', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to end of Month 3', 'description': 'Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.7', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '-7.6', 'spread': '1.07', 'groupId': 'OG002'}, {'value': '-6.9', 'spread': '1.10', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to end of Month 3', 'description': 'Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Week 2 (n=34, 42, 23, NA, NA, 10)', 'categories': [{'measurements': [{'value': '31.78', 'groupId': 'OG000'}, {'value': '40.38', 'groupId': 'OG001'}, {'value': '21.70', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '9.52', 'groupId': 'OG005'}]}]}, {'title': 'Month 1 (n=45, 51, 43, NA, NA, 23)', 'categories': [{'measurements': [{'value': '42.06', 'groupId': 'OG000'}, {'value': '49.04', 'groupId': 'OG001'}, {'value': '40.57', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '21.90', 'groupId': 'OG005'}]}]}, {'title': 'Month 2 (n=54, 69, 62, NA, NA, 36)', 'categories': [{'measurements': [{'value': '50.47', 'groupId': 'OG000'}, {'value': '66.35', 'groupId': 'OG001'}, {'value': '58.49', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '34.29', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=55, 73, 65, NA, NA, 47)', 'categories': [{'measurements': [{'value': '51.40', 'groupId': 'OG000'}, {'value': '70.19', 'groupId': 'OG001'}, {'value': '61.32', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '44.76', 'groupId': 'OG005'}]}]}, {'title': 'Month 4 (n=68, 68, 71, 32, 30, NA)', 'categories': [{'measurements': [{'value': '63.55', 'groupId': 'OG000'}, {'value': '65.38', 'groupId': 'OG001'}, {'value': '66.98', 'groupId': 'OG002'}, {'value': '61.54', 'groupId': 'OG003'}, {'value': '56.60', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=61, 75, 71, 35, 35, NA)', 'categories': [{'measurements': [{'value': '57.01', 'groupId': 'OG000'}, {'value': '72.12', 'groupId': 'OG001'}, {'value': '66.98', 'groupId': 'OG002'}, {'value': '67.31', 'groupId': 'OG003'}, {'value': '66.04', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=75, 73, 71, 36, 37, NA)', 'categories': [{'measurements': [{'value': '70.09', 'groupId': 'OG000'}, {'value': '70.19', 'groupId': 'OG001'}, {'value': '66.98', 'groupId': 'OG002'}, {'value': '69.23', 'groupId': 'OG003'}, {'value': '69.81', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=69, 76, 69, 39, 33, NA)', 'categories': [{'measurements': [{'value': '64.49', 'groupId': 'OG000'}, {'value': '73.08', 'groupId': 'OG001'}, {'value': '65.09', 'groupId': 'OG002'}, {'value': '75.00', 'groupId': 'OG003'}, {'value': '62.26', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12', 'description': "The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug. n=number of responders.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response", 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=100, 96, 100, NA, NA, 99)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.08', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.2', 'spread': '0.08', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=98, 97, 98, NA, NA, 98)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.09', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.4', 'spread': '0.09', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=96, 94, 96, 46, 46, NA)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '0.09', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.12', 'groupId': 'OG003'}, {'value': '-0.9', 'spread': '0.13', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=95, 91, 94, 45, 44, NA)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '0.09', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.12', 'groupId': 'OG003'}, {'value': '-1.3', 'spread': '0.13', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=91, 90, 92, 41, 43, NA)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '0.09', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '0.13', 'groupId': 'OG003'}, {'value': '-1.3', 'spread': '0.13', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO\\>0 and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=19, 19, 11, NA, NA, 4)', 'categories': [{'measurements': [{'value': '23.17', 'spread': '4.66', 'groupId': 'OG000'}, {'value': '27.14', 'spread': '5.32', 'groupId': 'OG001'}, {'value': '14.29', 'spread': '3.99', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '4.88', 'spread': '2.38', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=35, 31, 30, NA, NA, 12)', 'categories': [{'measurements': [{'value': '42.68', 'spread': '5.46', 'groupId': 'OG000'}, {'value': '44.29', 'spread': '5.94', 'groupId': 'OG001'}, {'value': '38.96', 'spread': '5.56', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '14.63', 'spread': '3.90', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=38, 42, 42, 12, 17, NA)', 'categories': [{'measurements': [{'value': '46.34', 'spread': '5.51', 'groupId': 'OG000'}, {'value': '60.00', 'spread': '5.86', 'groupId': 'OG001'}, {'value': '54.55', 'spread': '5.67', 'groupId': 'OG002'}, {'value': '28.57', 'spread': '6.97', 'groupId': 'OG003'}, {'value': '42.50', 'spread': '7.82', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=36, 48, 45, 14, 20, NA)', 'categories': [{'measurements': [{'value': '43.90', 'spread': '5.448', 'groupId': 'OG000'}, {'value': '68.57', 'spread': '5.55', 'groupId': 'OG001'}, {'value': '58.44', 'spread': '5.62', 'groupId': 'OG002'}, {'value': '33.33', 'spread': '7.27', 'groupId': 'OG003'}, {'value': '50.00', 'spread': '7.91', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=46, 47, 43, 15, 21, NA)', 'categories': [{'measurements': [{'value': '56.10', 'spread': '5.48', 'groupId': 'OG000'}, {'value': '67.14', 'spread': '5.61', 'groupId': 'OG001'}, {'value': '55.84', 'spread': '5.66', 'groupId': 'OG002'}, {'value': '35.71', 'spread': '7.39', 'groupId': 'OG003'}, {'value': '52.50', 'spread': '7.90', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 1, 3, 6, 9, and 12', 'description': 'PASI determines psoriasis severity based on lesion severity \\& percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, \\& scaling, evaluated separately for head \\& neck, upper limbs, trunk, \\& lower limbs \\& rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis \\& is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score \\& can vary in increments of 0.1 \\& range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug with PASI\\>0 and BSA ≥3% at baseline. n=number of responders.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dactylitis Severity Score (DSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=58, 59, 56, NA, NA, 56)', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '0.87', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '0.93', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '0.6', 'spread': '1.02', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=58, 60 , 56, NA, NA, 55)', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '0.97', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '-2.0', 'spread': '1.06', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=58, 59, 55, 28, 25, NA)', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '1.03', 'groupId': 'OG002'}, {'value': '-5.9', 'spread': '1.45', 'groupId': 'OG003'}, {'value': '-5.2', 'spread': '1.50', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=57, 59, 53, 27, 25, NA)', 'categories': [{'measurements': [{'value': '-7.0', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-6.5', 'spread': '0.63', 'groupId': 'OG002'}, {'value': '-5.3', 'spread': '0.87', 'groupId': 'OG003'}, {'value': '-7.9', 'spread': '0.89', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=54, 58, 52, 26, 24, NA)', 'categories': [{'measurements': [{'value': '-7.4', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '0.62', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '-6.7', 'spread': '0.93', 'groupId': 'OG003'}, {'value': '-7.7', 'spread': '0.96', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=no tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a patient is 0-60. Higher score indicates greater degree of tenderness.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug with baseline DSS\\>0 and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=79, 80, 80, NA, NA, 78)', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.317', 'groupId': 'OG000'}, {'value': '-1.27', 'spread': '0.321', 'groupId': 'OG001'}, {'value': '-0.95', 'spread': '0.336', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.58', 'spread': '0.355', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=77, 79, 79, NA, NA, 78)', 'categories': [{'measurements': [{'value': '-1.84', 'spread': '0.363', 'groupId': 'OG000'}, {'value': '-2.41', 'spread': '0.364', 'groupId': 'OG001'}, {'value': '-1.90', 'spread': '0.375', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '-1.17', 'spread': '0.393', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=76, 78, 76, 33, 39, NA)', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '0.35', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '0.50', 'groupId': 'OG003'}, {'value': '-2.5', 'spread': '0.48', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=75, 75, 73, 34, 37, NA)', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '0.46', 'groupId': 'OG003'}, {'value': '-3.2', 'spread': '0.44', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=72, 73, 72, 31, 37, NA)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '0.35', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '0.49', 'groupId': 'OG003'}, {'value': '-3.2', 'spread': '0.46', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score\\>0 and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Leeds Enthesitis Index (LEI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '65', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=74, 63, 75, NA, NA, 65)', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.213', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '0.203', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.26', 'spread': '0.219', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=70, 63, 73, NA, NA, 63)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.221', 'groupId': 'OG000'}, {'value': '-1.46', 'spread': '0.240', 'groupId': 'OG001'}, {'value': '-1.10', 'spread': '0.228', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.43', 'spread': '0.246', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=72, 61, 71, 27, 31, NA)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '0.32', 'groupId': 'OG003'}, {'value': '-1.3', 'spread': '0.30', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=70, 58, 68, 27, 29, NA)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.21', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.31', 'groupId': 'OG003'}, {'value': '-1.7', 'spread': '0.30', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=67, 56, 67, 24, 29, NA)', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.20', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.30', 'groupId': 'OG003'}, {'value': '-1.9', 'spread': '0.28', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0-6. Higher score indicates a greater number of sites that are affected by enthesitis.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug with baseline LEI\\>0 and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103,104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '3.39', 'spread': '0.638', 'groupId': 'OG000'}, {'value': '4.66', 'spread': '0.645', 'groupId': 'OG001'}, {'value': '4.00', 'spread': '0.655', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '1.54', 'spread': '0.700', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=102, 103,100, NA, NA, 102)', 'categories': [{'measurements': [{'value': '5.51', 'spread': '0.733', 'groupId': 'OG000'}, {'value': '5.69', 'spread': '0.735', 'groupId': 'OG001'}, {'value': '6.23', 'spread': '0.748', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '2.68', 'spread': '0.785', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 98, 48, 48, NA)', 'categories': [{'measurements': [{'value': '6.72', 'spread': '0.773', 'groupId': 'OG000'}, {'value': '6.70', 'spread': '0.777', 'groupId': 'OG001'}, {'value': '6.26', 'spread': '0.788', 'groupId': 'OG002'}, {'value': '5.86', 'spread': '1.101', 'groupId': 'OG003'}, {'value': '6.07', 'spread': '1.112', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 95, 47, 46, NA)', 'categories': [{'measurements': [{'value': '7.52', 'spread': '0.781', 'groupId': 'OG000'}, {'value': '7.21', 'spread': '0.787', 'groupId': 'OG001'}, {'value': '6.91', 'spread': '0.798', 'groupId': 'OG002'}, {'value': '6.16', 'spread': '1.115', 'groupId': 'OG003'}, {'value': '7.15', 'spread': '1.130', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 43, NA)', 'categories': [{'measurements': [{'value': '7.61', 'spread': '0.806', 'groupId': 'OG000'}, {'value': '7.67', 'spread': '0.810', 'groupId': 'OG001'}, {'value': '6.74', 'spread': '0.822', 'groupId': 'OG002'}, {'value': '5.82', 'spread': '1.160', 'groupId': 'OG003'}, {'value': '5.72', 'spread': '1.177', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103,104,NA, NA, 103)', 'categories': [{'measurements': [{'value': '4.12', 'spread': '0.841', 'groupId': 'OG000'}, {'value': '3.63', 'spread': '0.849', 'groupId': 'OG001'}, {'value': '2.13', 'spread': '0.871', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '3.19', 'spread': '0.917', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=102, 103,100, NA, NA, 102)', 'categories': [{'measurements': [{'value': '4.35', 'spread': '0.909', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '0.909', 'groupId': 'OG001'}, {'value': '3.13', 'spread': '0.938', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '3.27', 'spread': '0.976', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 98, 48, 48, NA)', 'categories': [{'measurements': [{'value': '5.70', 'spread': '0.927', 'groupId': 'OG000'}, {'value': '5.51', 'spread': '0.930', 'groupId': 'OG001'}, {'value': '4.58', 'spread': '0.955', 'groupId': 'OG002'}, {'value': '4.50', 'spread': '1.319', 'groupId': 'OG003'}, {'value': '3.62', 'spread': '1.331', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 95, 47, 46, NA)', 'categories': [{'measurements': [{'value': '5.07', 'spread': '0.974', 'groupId': 'OG000'}, {'value': '6.20', 'spread': '0.982', 'groupId': 'OG001'}, {'value': '3.68', 'spread': '1.005', 'groupId': 'OG002'}, {'value': '4.61', 'spread': '1.391', 'groupId': 'OG003'}, {'value': '6.03', 'spread': '1.409', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 43, NA)', 'categories': [{'measurements': [{'value': '4.82', 'spread': '1.012', 'groupId': 'OG000'}, {'value': '6.26', 'spread': '1.016', 'groupId': 'OG001'}, {'value': '4.81', 'spread': '1.039', 'groupId': 'OG002'}, {'value': '4.51', 'spread': '1.455', 'groupId': 'OG003'}, {'value': '4.43', 'spread': '1.474', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103,104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '2.43', 'spread': '0.768', 'groupId': 'OG000'}, {'value': '3.89', 'spread': '0.776', 'groupId': 'OG001'}, {'value': '2.81', 'spread': '0.787', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '1.10', 'spread': '0.840', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=102, 103,101, NA, NA, 102)', 'categories': [{'measurements': [{'value': '5.17', 'spread': '0.846', 'groupId': 'OG000'}, {'value': '5.23', 'spread': '0.848', 'groupId': 'OG001'}, {'value': '5.22', 'spread': '0.862', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '2.06', 'spread': '0.910', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '7.02', 'spread': '0.897', 'groupId': 'OG000'}, {'value': '6.15', 'spread': '0.900', 'groupId': 'OG001'}, {'value': '6.36', 'spread': '0.912', 'groupId': 'OG002'}, {'value': '5.22', 'spread': '1.276', 'groupId': 'OG003'}, {'value': '5.22', 'spread': '1.291', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '7.43', 'spread': '0.902', 'groupId': 'OG000'}, {'value': '6.67', 'spread': '0.909', 'groupId': 'OG001'}, {'value': '7.01', 'spread': '0.921', 'groupId': 'OG002'}, {'value': '5.69', 'spread': '1.285', 'groupId': 'OG003'}, {'value': '6.25', 'spread': '1.306', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '7.67', 'spread': '0.899', 'groupId': 'OG000'}, {'value': '7.11', 'spread': '0.903', 'groupId': 'OG001'}, {'value': '6.81', 'spread': '0.917', 'groupId': 'OG002'}, {'value': '6.49', 'spread': '1.292', 'groupId': 'OG003'}, {'value': '4.77', 'spread': '1.308', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103,104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '4.05', 'spread': '0.751', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '0.759', 'groupId': 'OG001'}, {'value': '4.09', 'spread': '0.770', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '1.98', 'spread': '0.820', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=102, 103, 100, NA, NA, 102)', 'categories': [{'measurements': [{'value': '4.45', 'spread': '0.801', 'groupId': 'OG000'}, {'value': '4.79', 'spread': '0.803', 'groupId': 'OG001'}, {'value': '5.21', 'spread': '0.820', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '3.63', 'spread': '0.862', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '6.02', 'spread': '0.824', 'groupId': 'OG000'}, {'value': '5.21', 'spread': '0.828', 'groupId': 'OG001'}, {'value': '5.48', 'spread': '0.840', 'groupId': 'OG002'}, {'value': '4.97', 'spread': '1.172', 'groupId': 'OG003'}, {'value': '5.03', 'spread': '1.185', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '6.24', 'spread': '0.853', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '0.861', 'groupId': 'OG001'}, {'value': '5.79', 'spread': '0.872', 'groupId': 'OG002'}, {'value': '4.68', 'spread': '1.217', 'groupId': 'OG003'}, {'value': '6.70', 'spread': '1.234', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '6.21', 'spread': '0.888', 'groupId': 'OG000'}, {'value': '7.11', 'spread': '0.892', 'groupId': 'OG001'}, {'value': '6.37', 'spread': '0.906', 'groupId': 'OG002'}, {'value': '2.98', 'spread': '1.279', 'groupId': 'OG003'}, {'value': '5.03', 'spread': '1.291', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103,104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '5.53', 'spread': '0.777', 'groupId': 'OG000'}, {'value': '7.16', 'spread': '0.786', 'groupId': 'OG001'}, {'value': '6.42', 'spread': '0.802', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '3.44', 'spread': '0.851', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=102, 103, 101, NA, NA, 102)', 'categories': [{'measurements': [{'value': '7.75', 'spread': '0.838', 'groupId': 'OG000'}, {'value': '8.05', 'spread': '0.840', 'groupId': 'OG001'}, {'value': '7.52', 'spread': '0.859', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '3.77', 'spread': '0.903', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '7.76', 'spread': '0.985', 'groupId': 'OG000'}, {'value': '10.65', 'spread': '0.989', 'groupId': 'OG001'}, {'value': '7.76', 'spread': '1.004', 'groupId': 'OG002'}, {'value': '8.55', 'spread': '1.405', 'groupId': 'OG003'}, {'value': '8.98', 'spread': '1.425', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '9.03', 'spread': '0.953', 'groupId': 'OG000'}, {'value': '10.13', 'spread': '0.960', 'groupId': 'OG001'}, {'value': '8.59', 'spread': '0.977', 'groupId': 'OG002'}, {'value': '8.46', 'spread': '1.362', 'groupId': 'OG003'}, {'value': '10.81', 'spread': '1.389', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 43, NA)', 'categories': [{'measurements': [{'value': '9.15', 'spread': '0.961', 'groupId': 'OG000'}, {'value': '11.38', 'spread': '0.965', 'groupId': 'OG001'}, {'value': '9.18', 'spread': '0.984', 'groupId': 'OG002'}, {'value': '8.59', 'spread': '1.384', 'groupId': 'OG003'}, {'value': '8.61', 'spread': '1.413', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103,104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '3.29', 'spread': '0.610', 'groupId': 'OG000'}, {'value': '3.87', 'spread': '0.616', 'groupId': 'OG001'}, {'value': '1.96', 'spread': '0.625', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '2.15', 'spread': '0.666', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=102, 103,101, NA, NA, 102 )', 'categories': [{'measurements': [{'value': '4.09', 'spread': '0.700', 'groupId': 'OG000'}, {'value': '3.95', 'spread': '0.701', 'groupId': 'OG001'}, {'value': '4.73', 'spread': '0.713', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '2.64', 'spread': '0.748', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '5.96', 'spread': '0.720', 'groupId': 'OG000'}, {'value': '4.12', 'spread': '0.722', 'groupId': 'OG001'}, {'value': '4.81', 'spread': '0.733', 'groupId': 'OG002'}, {'value': '4.39', 'spread': '1.022', 'groupId': 'OG003'}, {'value': '3.92', 'spread': '1.033', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '5.93', 'spread': '0.773', 'groupId': 'OG000'}, {'value': '5.18', 'spread': '0.778', 'groupId': 'OG001'}, {'value': '4.09', 'spread': '0.788', 'groupId': 'OG002'}, {'value': '4.72', 'spread': '1.102', 'groupId': 'OG003'}, {'value': '4.85', 'spread': '1.117', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '5.70', 'spread': '0.811', 'groupId': 'OG000'}, {'value': '4.63', 'spread': '0.815', 'groupId': 'OG001'}, {'value': '4.21', 'spread': '0.825', 'groupId': 'OG002'}, {'value': '4.50', 'spread': '1.164', 'groupId': 'OG003'}, {'value': '4.12', 'spread': '1.175', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103,104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '3.64', 'spread': '0.802', 'groupId': 'OG000'}, {'value': '4.59', 'spread': '0.806', 'groupId': 'OG001'}, {'value': '2.42', 'spread': '0.826', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '2.16', 'spread': '0.877', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=102, 103, 101, NA, NA, 102)', 'categories': [{'measurements': [{'value': '5.50', 'spread': '0.889', 'groupId': 'OG000'}, {'value': '5.90', 'spread': '0.887', 'groupId': 'OG001'}, {'value': '4.93', 'spread': '0.909', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '3.05', 'spread': '0.954', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '6.81', 'spread': '0.969', 'groupId': 'OG000'}, {'value': '7.41', 'spread': '0.970', 'groupId': 'OG001'}, {'value': '5.05', 'spread': '0.989', 'groupId': 'OG002'}, {'value': '5.34', 'spread': '1.378', 'groupId': 'OG003'}, {'value': '4.62', 'spread': '1.394', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '6.09', 'spread': '1.017', 'groupId': 'OG000'}, {'value': '7.82', 'spread': '1.023', 'groupId': 'OG001'}, {'value': '5.27', 'spread': '1.041', 'groupId': 'OG002'}, {'value': '6.61', 'spread': '1.451', 'groupId': 'OG003'}, {'value': '6.39', 'spread': '1.472', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '7.01', 'spread': '1.022', 'groupId': 'OG000'}, {'value': '7.02', 'spread': '1.024', 'groupId': 'OG001'}, {'value': '5.12', 'spread': '1.043', 'groupId': 'OG002'}, {'value': '5.62', 'spread': '1.465', 'groupId': 'OG003'}, {'value': '5.15', 'spread': '1.481', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103,104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '4.51', 'spread': '0.827', 'groupId': 'OG000'}, {'value': '4.46', 'spread': '0.838', 'groupId': 'OG001'}, {'value': '3.34', 'spread': '0.852', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '2.96', 'spread': '0.901', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=102, 103, 101, NA, NA, 102)', 'categories': [{'measurements': [{'value': '5.95', 'spread': '0.897', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '0.898', 'groupId': 'OG001'}, {'value': '5.26', 'spread': '0.918', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '3.63', 'spread': '0.961', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '6.97', 'spread': '0.955', 'groupId': 'OG000'}, {'value': '7.08', 'spread': '0.959', 'groupId': 'OG001'}, {'value': '7.10', 'spread': '0.975', 'groupId': 'OG002'}, {'value': '5.44', 'spread': '1.362', 'groupId': 'OG003'}, {'value': '6.05', 'spread': '1.373', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '7.66', 'spread': '0.947', 'groupId': 'OG000'}, {'value': '7.74', 'spread': '0.957', 'groupId': 'OG001'}, {'value': '5.69', 'spread': '0.972', 'groupId': 'OG002'}, {'value': '5.95', 'spread': '1.355', 'groupId': 'OG003'}, {'value': '8.93', 'spread': '1.373', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '6.13', 'spread': '0.989', 'groupId': 'OG000'}, {'value': '8.42', 'spread': '0.995', 'groupId': 'OG001'}, {'value': '6.32', 'spread': '1.012', 'groupId': 'OG002'}, {'value': '6.19', 'spread': '1.427', 'groupId': 'OG003'}, {'value': '6.41', 'spread': '1.445', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number pf participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103,104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '4.77', 'spread': '0.960', 'groupId': 'OG000'}, {'value': '3.87', 'spread': '0.971', 'groupId': 'OG001'}, {'value': '2.93', 'spread': '0.991', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '4.52', 'spread': '1.042', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=102, 103, 100, NA, NA, 102)', 'categories': [{'measurements': [{'value': '4.21', 'spread': '1.010', 'groupId': 'OG000'}, {'value': '4.82', 'spread': '1.011', 'groupId': 'OG001'}, {'value': '3.35', 'spread': '1.040', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG004'}, {'value': '3.68', 'spread': '1.083', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 98, 48, 48, NA)', 'categories': [{'measurements': [{'value': '5.67', 'spread': '1.024', 'groupId': 'OG000'}, {'value': '4.68', 'spread': '1.027', 'groupId': 'OG001'}, {'value': '4.77', 'spread': '1.051', 'groupId': 'OG002'}, {'value': '6.34', 'spread': '1.458', 'groupId': 'OG003'}, {'value': '4.56', 'spread': '1.473', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 95, 47, 46, NA)', 'categories': [{'measurements': [{'value': '5.13', 'spread': '1.021', 'groupId': 'OG000'}, {'value': '6.13', 'spread': '1.030', 'groupId': 'OG001'}, {'value': '4.87', 'spread': '1.052', 'groupId': 'OG002'}, {'value': '5.89', 'spread': '1.456', 'groupId': 'OG003'}, {'value': '6.52', 'spread': '1.478', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '5.15', 'spread': '1.048', 'groupId': 'OG000'}, {'value': '6.73', 'spread': '1.053', 'groupId': 'OG001'}, {'value': '6.03', 'spread': '1.075', 'groupId': 'OG002'}, {'value': '4.77', 'spread': '1.509', 'groupId': 'OG003'}, {'value': '4.94', 'spread': '1.525', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103, 104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '3.32', 'spread': '0.867', 'groupId': 'OG000'}, {'value': '3.87', 'spread': '0.874', 'groupId': 'OG001'}, {'value': '2.79', 'spread': '0.895', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '1.57', 'spread': '0.952', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=102, 103, 101, NA, NA, 102)', 'categories': [{'measurements': [{'value': '4.45', 'spread': '0.934', 'groupId': 'OG000'}, {'value': '4.23', 'spread': '0.932', 'groupId': 'OG001'}, {'value': '3.95', 'spread': '0.956', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '2.62', 'spread': '1.009', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '6.11', 'spread': '0.951', 'groupId': 'OG000'}, {'value': '6.38', 'spread': '0.953', 'groupId': 'OG001'}, {'value': '5.35', 'spread': '0.974', 'groupId': 'OG002'}, {'value': '3.70', 'spread': '1.354', 'groupId': 'OG003'}, {'value': '3.41', 'spread': '1.372', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '5.79', 'spread': '1.022', 'groupId': 'OG000'}, {'value': '6.43', 'spread': '1.028', 'groupId': 'OG001'}, {'value': '4.62', 'spread': '1.048', 'groupId': 'OG002'}, {'value': '3.57', 'spread': '1.461', 'groupId': 'OG003'}, {'value': '5.45', 'spread': '1.483', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '5.86', 'spread': '1.019', 'groupId': 'OG000'}, {'value': '6.58', 'spread': '1.022', 'groupId': 'OG001'}, {'value': '5.86', 'spread': '1.044', 'groupId': 'OG002'}, {'value': '4.72', 'spread': '1.467', 'groupId': 'OG003'}, {'value': '4.48', 'spread': '1.483', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility", 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103, 104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.043', 'groupId': 'OG001'}, {'value': '-0.15', 'spread': '0.043', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.10', 'spread': '0.046', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=101, 103, 101, NA, NA, 102)', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '-0.29', 'spread': '0.048', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.11', 'spread': '0.050', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG003'}, {'value': '-0.2', 'spread': '0.07', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44,44, NA)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.07', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': "The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \\[1\\], some or moderate problems \\[2\\], or extreme problems \\[3\\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care", 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 102, 104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.046', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '0.047', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.09', 'spread': '0.050', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=101, 102, 101, NA, NA, 102)', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '0.048', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.12', 'spread': '0.051', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 99, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.06', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.06', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.06', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG003'}, {'value': '-0.2', 'spread': '0.07', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': "The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \\[1\\], some or moderate problems \\[2\\], or extreme problems \\[3\\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities", 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 102, 104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.043', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.043', 'groupId': 'OG001'}, {'value': '-0.21', 'spread': '0.044', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.06', 'spread': '0.047', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=101, 102, 101, NA, NA, 102)', 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.049', 'groupId': 'OG001'}, {'value': '-0.29', 'spread': '0.049', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.17', 'spread': '0.052', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 99, 99, 48, 47, NA)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG003'}, {'value': '-0.4', 'spread': '0.07', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': "The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \\[1\\], some or moderate problems \\[2\\], or extreme problems \\[3\\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort", 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103, 104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.039', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.040', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.08', 'spread': '0.043', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=101, 103, 101, NA, NA, 102)', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.044', 'groupId': 'OG001'}, {'value': '-0.28', 'spread': '0.045', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.08', 'spread': '0.047', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG003'}, {'value': '-0.4', 'spread': '0.07', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.07', 'groupId': 'OG003'}, {'value': '-0.4', 'spread': '0.07', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.07', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.07', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': "The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \\[1\\], some or moderate problems \\[2\\], or extreme problems \\[3\\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression", 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103, 104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.052', 'groupId': 'OG001'}, {'value': '-0.27', 'spread': '0.053', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.21', 'spread': '0.056', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=101, 103, 100, NA, NA, 102)', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.055', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.055', 'groupId': 'OG001'}, {'value': '-0.32', 'spread': '0.056', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-0.21', 'spread': '0.059', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.08', 'groupId': 'OG003'}, {'value': '-0.2', 'spread': '0.08', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.06', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.08', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.08', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.06', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.08', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.08', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': "The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \\[1\\], some or moderate problems \\[2\\], or extreme problems \\[3\\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today", 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103, 104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '10.75', 'spread': '1.859', 'groupId': 'OG000'}, {'value': '10.81', 'spread': '1.880', 'groupId': 'OG001'}, {'value': '10.27', 'spread': '1.917', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '6.59', 'spread': '2.027', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=101, 103, 101, NA, NA, 101)', 'categories': [{'measurements': [{'value': '14.00', 'spread': '2.100', 'groupId': 'OG000'}, {'value': '15.83', 'spread': '2.092', 'groupId': 'OG001'}, {'value': '13.10', 'spread': '2.138', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '6.37', 'spread': '2.242', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99, 48, 48, NA)', 'categories': [{'measurements': [{'value': '19.5', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '15.5', 'spread': '2.12', 'groupId': 'OG002'}, {'value': '14.7', 'spread': '2.97', 'groupId': 'OG003'}, {'value': '16.6', 'spread': '3.00', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '19.2', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '2.23', 'groupId': 'OG001'}, {'value': '18.2', 'spread': '2.26', 'groupId': 'OG002'}, {'value': '12.8', 'spread': '3.16', 'groupId': 'OG003'}, {'value': '21.5', 'spread': '3.21', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '20.7', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '16.5', 'spread': '2.14', 'groupId': 'OG002'}, {'value': '16.0', 'spread': '3.02', 'groupId': 'OG003'}, {'value': '19.8', 'spread': '3.05', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': "The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \\[1\\], some or moderate problems \\[2\\], or extreme problems \\[3\\]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103, 104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '5.2', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '0.79', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '2.7', 'spread': '0.84', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (102, 102, 101, NA, NA, 102)', 'categories': [{'measurements': [{'value': '7.0', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '0.87', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '3.3', 'spread': '0.91', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99,48, 48, NA)', 'categories': [{'measurements': [{'value': '7.9', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '0.91', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '1.26', 'groupId': 'OG003'}, {'value': '7.2', 'spread': '1.28', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '7.9', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '5.5', 'spread': '1.31', 'groupId': 'OG003'}, {'value': '8.4', 'spread': '1.33', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '8.5', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '0.97', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '1.36', 'groupId': 'OG003'}, {'value': '7.6', 'spread': '1.38', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103, 104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.36', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '1.2', 'spread': '0.38', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=102, 102, 101, NA, NA, 102)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.39', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '1.6', 'spread': '0.41', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99,48, 48, NA)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '0.41', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '0.57', 'groupId': 'OG003'}, {'value': '3.3', 'spread': '0.58', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.43', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '0.59', 'groupId': 'OG003'}, {'value': '3.9', 'spread': '0.60', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '0.45', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '0.63', 'groupId': 'OG003'}, {'value': '3.4', 'spread': '0.63', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=105, 103, 104, NA, NA, 103)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.49', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '1.5', 'spread': '0.52', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=102, 102, 101, NA, NA, 102)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '0.53', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '1.8', 'spread': '0.56', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=100, 100, 99,48, 48, NA)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.54', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '0.75', 'groupId': 'OG003'}, {'value': '4.0', 'spread': '0.76', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=99, 97, 96, 47, 46, NA)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '0.78', 'groupId': 'OG003'}, {'value': '4.6', 'spread': '0.80', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=96, 96, 94, 44, 44, NA)', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.58', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '0.82', 'groupId': 'OG003'}, {'value': '4.3', 'spread': '0.82', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'OG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'OG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'OG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'OG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.'}], 'classes': [{'title': 'Month 1 (n=24, 21, 10, NA, NA, 22)', 'categories': [{'measurements': [{'value': '-1.23', 'spread': '0.537', 'groupId': 'OG000'}, {'value': '-1.60', 'spread': '0.508', 'groupId': 'OG001'}, {'value': '-2.30', 'spread': '0.673', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-1.27', 'spread': '0.581', 'groupId': 'OG005'}]}]}, {'title': 'Month 3 (n=24, 21, 10, NA, NA, 22)', 'categories': [{'measurements': [{'value': '-1.83', 'spread': '0.579', 'groupId': 'OG000'}, {'value': '-2.78', 'spread': '0.559', 'groupId': 'OG001'}, {'value': '-2.93', 'spread': '0.753', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG004'}, {'value': '-1.60', 'spread': '0.624', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (n=23, 21, 10, 9, 11, NA)', 'categories': [{'measurements': [{'value': '-2.24', 'spread': '0.580', 'groupId': 'OG000'}, {'value': '-2.35', 'spread': '0.560', 'groupId': 'OG001'}, {'value': '-3.58', 'spread': '0.758', 'groupId': 'OG002'}, {'value': '-2.85', 'spread': '0.778', 'groupId': 'OG003'}, {'value': '-3.31', 'spread': '0.744', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 9 (n=23, 20, 10, 9, 9, NA)', 'categories': [{'measurements': [{'value': '-2.06', 'spread': '0.575', 'groupId': 'OG000'}, {'value': '-2.71', 'spread': '0.558', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '0.747', 'groupId': 'OG002'}, {'value': '-3.00', 'spread': '0.770', 'groupId': 'OG003'}, {'value': '-3.35', 'spread': '0.761', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (n=23, 19, 10, 9, 9, NA)', 'categories': [{'measurements': [{'value': '-2.50', 'spread': '0.594', 'groupId': 'OG000'}, {'value': '-3.30', 'spread': '0.587', 'groupId': 'OG001'}, {'value': '-2.42', 'spread': '0.779', 'groupId': 'OG002'}, {'value': '-2.31', 'spread': '0.808', 'groupId': 'OG003'}, {'value': '-2.67', 'spread': '0.806', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Results were not reported for this group.', 'groupId': 'OG005'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score\\>0 cm and were evaluable. n=number of participants evaluable at each visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'FG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'FG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'FG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'FG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Received treatment', 'groupId': 'FG000', 'numSubjects': '107'}, {'comment': 'Received treatment', 'groupId': 'FG001', 'numSubjects': '104'}, {'comment': 'Received treatment', 'groupId': 'FG002', 'numSubjects': '106'}, {'comment': 'Received treatment', 'groupId': 'FG003', 'numSubjects': '52'}, {'comment': 'Received treatment', 'groupId': 'FG004', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '94'}, {'groupId': 'FG003', 'numSubjects': '44'}, {'groupId': 'FG004', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'No longer met study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Insufficient clinical response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Adverse event related to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Adverse event unrelated to study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Of 611 participants screened for entry into the study, 422 received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '422', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.'}, {'id': 'BG001', 'title': 'Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'BG002', 'title': 'Adalimumab, 40 mg, Every 2 Weeks', 'description': 'Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.'}, {'id': 'BG003', 'title': 'Placebo/Tofacitinib, 5 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.'}, {'id': 'BG004', 'title': 'Placebo/Tofacitinib, 10 mg, Twice Daily', 'description': 'Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.4', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '46.9', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '47.4', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '46.1', 'spread': '10.4', 'groupId': 'BG003'}, {'value': '49.3', 'spread': '13.8', 'groupId': 'BG004'}, {'value': '47.9', 'spread': '12.1', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '225', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '197', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received at least 1 dose of study drug.'}}, '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': 422}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-06', 'studyFirstSubmitDate': '2013-06-12', 'resultsFirstSubmitDate': '2016-12-04', 'studyFirstSubmitQcDate': '2013-06-12', 'lastUpdatePostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-06', 'studyFirstPostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3', 'timeFrame': 'At end of Month 3', 'description': "ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP)."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score', 'timeFrame': 'From Baseline to Month 3', 'description': 'The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis', 'timeFrame': 'From Baseline to Month 12', 'description': 'Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing.'}, {'measure': 'Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12', 'timeFrame': 'At Month 12', 'description': 'Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS \\>0.5 from baseline.'}, {'measure': 'Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12', 'timeFrame': 'At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12', 'description': "ACR50 was calculated as a ≥50% improvement from baseline in tender/painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP."}, {'measure': 'Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12', 'timeFrame': 'At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12', 'description': "ACR70 was calculated as a ≥70% improvement from baseline in tender/painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.\n\n."}, {'measure': 'Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12', 'timeFrame': 'At Week 2 and Months 1, 2, 4, 6, 9, and 12', 'description': "ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score', 'timeFrame': 'From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12', 'description': 'The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.'}, {'measure': 'Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels', 'timeFrame': 'From Baseline to end of Month 3', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.'}, {'measure': "Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain", 'timeFrame': 'From Baseline to end of Month 3', 'description': 'Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.'}, {'measure': "Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis", 'timeFrame': 'From Baseline to end of Month 3', 'description': 'Participant answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant\'s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).'}, {'measure': "Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis", 'timeFrame': 'From Baseline to end of Month 3', 'description': "The blinded investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor)."}, {'measure': 'Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count', 'timeFrame': 'From Baseline to end of Month 3', 'description': 'Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.'}, {'measure': 'Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count', 'timeFrame': 'From Baseline to end of Month 3', 'description': 'Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.'}, {'measure': 'Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12', 'timeFrame': 'At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12', 'description': "The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count."}, {'measure': "Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response", 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).'}, {'measure': 'Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12', 'timeFrame': 'At Months 1, 3, 6, 9, and 12', 'description': 'PASI determines psoriasis severity based on lesion severity \\& percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, \\& scaling, evaluated separately for head \\& neck, upper limbs, trunk, \\& lower limbs \\& rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis \\& is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score \\& can vary in increments of 0.1 \\& range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI.'}, {'measure': 'Change From Baseline in Dactylitis Severity Score (DSS)', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=no tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a patient is 0-60. Higher score indicates greater degree of tenderness.'}, {'measure': 'Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.'}, {'measure': 'Change From Baseline in the Leeds Enthesitis Index (LEI)', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0-6. Higher score indicates a greater number of sites that are affected by enthesitis.'}, {'measure': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.'}, {'measure': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.'}, {'measure': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning.'}, {'measure': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning.'}, {'measure': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain.'}, {'measure': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions.'}, {'measure': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality.'}, {'measure': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning.'}, {'measure': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning.'}, {'measure': 'Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning.'}, {'measure': "Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility", 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': "The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \\[1\\], some or moderate problems \\[2\\], or extreme problems \\[3\\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status."}, {'measure': "Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care", 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': "The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \\[1\\], some or moderate problems \\[2\\], or extreme problems \\[3\\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status."}, {'measure': "Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities", 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': "The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \\[1\\], some or moderate problems \\[2\\], or extreme problems \\[3\\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status."}, {'measure': "Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort", 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': "The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \\[1\\], some or moderate problems \\[2\\], or extreme problems \\[3\\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status."}, {'measure': "Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression", 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': "The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \\[1\\], some or moderate problems \\[2\\], or extreme problems \\[3\\]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status."}, {'measure': "Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today", 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': "The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems \\[1\\], some or moderate problems \\[2\\], or extreme problems \\[3\\]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status."}, {'measure': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status.'}, {'measure': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience.'}, {'measure': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning.'}, {'measure': 'Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)', 'timeFrame': 'From Baseline to Months 1, 3, 6, 9, and 12', 'description': 'BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['psoriatic arthritis', 'radiographic changes', 'active comparator', 'tofacitinib'], 'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '41148555', 'type': 'DERIVED', 'citation': 'Gossec L, Sellas A, Gruben DC, Valderrama M, Gomez S, Kinch C, Citera G. Response to Tofacitinib in Patients with Psoriatic Arthritis and Probable Anxiety/Depressive Disorder: A Post Hoc Analysis of Phase 3 Trials. Rheumatol Ther. 2025 Dec;12(6):1175-1186. doi: 10.1007/s40744-025-00800-7. Epub 2025 Oct 28.'}, {'pmid': '40241921', 'type': 'DERIVED', 'citation': 'Gladman DD, Dougados M, Marzo-Ortega H, Cadatal MJ, Agarwal E, Kinch CD, Nash P. 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Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials. Clin Rheumatol. 2022 Feb;41(2):499-511. doi: 10.1007/s10067-021-05894-2. Epub 2021 Sep 12.'}, {'pmid': '34226183', 'type': 'DERIVED', 'citation': 'de Vlam K, Ogdie A, Bushmakin AG, Cappelleri JC, Fleischmann R, Taylor PC, Azevedo V, Fallon L, Woolcott J, Mease PJ. Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib. RMD Open. 2021 Jul;7(2):e001609. doi: 10.1136/rmdopen-2021-001609.'}, {'pmid': '33766074', 'type': 'DERIVED', 'citation': 'Coates LC, Bushmakin AG, FitzGerald O, Gladman DD, Fallon L, Cappelleri JC, Hsu MA, Helliwell PS. Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib. Arthritis Res Ther. 2021 Mar 26;23(1):94. doi: 10.1186/s13075-021-02474-2.'}, {'pmid': '32910531', 'type': 'DERIVED', 'citation': 'Ritchlin CT, Giles JT, Ogdie A, Gomez-Reino JJ, Helliwell P, Young P, Wang C, Wu J, Romero AB, Woolcott J, Stockert L. Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies. ACR Open Rheumatol. 2020 Oct;2(10):543-554. doi: 10.1002/acr2.11166. Epub 2020 Sep 10.'}, {'pmid': '32816215', 'type': 'DERIVED', 'citation': 'Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.'}, {'pmid': '32006348', 'type': 'DERIVED', 'citation': 'Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Apr;43(4):379-392. doi: 10.1007/s40264-020-00904-9.'}, {'pmid': '31112005', 'type': 'DERIVED', 'citation': 'Gladman DD, Charles-Schoeman C, McInnes IB, Veale DJ, Thiers B, Nurmohamed M, Graham D, Wang C, Jones T, Wolk R, DeMasi R. Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients With Psoriatic Arthritis: A Pooled Analysis Across Phase III and Long-Term Extension Studies. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1387-1395. doi: 10.1002/acr.23930.'}, {'pmid': '31111255', 'type': 'DERIVED', 'citation': 'Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4.'}, {'pmid': '30824647', 'type': 'DERIVED', 'citation': 'van der Heijde D, Gladman DD, FitzGerald O, Kavanaugh A, Graham D, Wang C, Fallon L. Radiographic Progression According to Baseline C-reactive Protein Levels and Other Risk Factors in Psoriatic Arthritis Treated with Tofacitinib or Adalimumab. J Rheumatol. 2019 Sep;46(9):1089-1096. doi: 10.3899/jrheum.180971. 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J Patient Rep Outcomes. 2019 Jan 24;3(1):5. doi: 10.1186/s41687-019-0094-5.', 'retractions': [{'pmid': '31139969', 'source': 'J Patient Rep Outcomes. 2019 May 28;3(1):32'}]}, {'pmid': '30414064', 'type': 'DERIVED', 'citation': 'Nash P, Coates LC, Fleischmann R, Papp KA, Gomez-Reino JJ, Kanik KS, Wang C, Wu J, Menon S, Hendrikx T, Ports WC. Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2018 Dec;5(2):567-582. doi: 10.1007/s40744-018-0131-5. Epub 2018 Nov 9.'}, {'pmid': '30373651', 'type': 'DERIVED', 'citation': 'Helliwell P, Coates LC, FitzGerald O, Nash P, Soriano ER, Elaine Husni M, Hsu MA, Kanik KS, Hendrikx T, Wu J, Kudlacz E. Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease. Arthritis Res Ther. 2018 Oct 29;20(1):242. doi: 10.1186/s13075-018-1739-0.'}, {'pmid': '29045212', 'type': 'DERIVED', 'citation': 'Mease P, Hall S, FitzGerald O, van der Heijde D, Merola JF, Avila-Zapata F, Cieslak D, Graham D, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med. 2017 Oct 19;377(16):1537-1550. doi: 10.1056/NEJMoa1615975.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921091&StudyName=Efficacy%20And%20Safety%20Of%20Tofacitinib%20In%20Psoriatic%20Arthritis%3A%20Comparator%20Study', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. 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