Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT02706951
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2016-02-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia', 'New Zealand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C000613732', 'term': 'upadacitinib'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 5 years', 'description': 'Adverse Event collection in Period 2 combined the Periods 1+2 Upadacitinib 15 mg Arm which includes 101 participants who were re-randomized from the Period 1 Methotrexate Arm in addition to the 217 participants who started in the Period 1 Upadacitinib 15 mg Arm. The Upadacitinib 30 mg Arm includes 96 participants who were re-randomized from the Period 1 Methotrexate Arm in addition to the 215 participants who started in the Period 1 Upadacitinib 30 mg Arm', 'eventGroups': [{'id': 'EG000', 'title': 'Period 1: Methotrexate', 'description': 'Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.', 'otherNumAtRisk': 216, 'deathsNumAtRisk': 216, 'otherNumAffected': 49, 'seriousNumAtRisk': 216, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Period 1: Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.', 'otherNumAtRisk': 217, 'deathsNumAtRisk': 217, 'otherNumAffected': 43, 'seriousNumAtRisk': 217, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Period 1: Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 51, 'seriousNumAtRisk': 215, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Periods 1+2: Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily', 'otherNumAtRisk': 318, 'deathsNumAtRisk': 318, 'otherNumAffected': 219, 'seriousNumAtRisk': 318, 'deathsNumAffected': 7, 'seriousNumAffected': 95}, {'id': 'EG004', 'title': 'Periods 1+ 2: Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily', 'otherNumAtRisk': 311, 'deathsNumAtRisk': 311, 'otherNumAffected': 211, 'seriousNumAtRisk': 311, 'deathsNumAffected': 5, 'seriousNumAffected': 75}, {'id': 'EG005', 'title': 'Period 2: Upadacitinib 15 mg Switched From Upadacitinib 30 mg', 'description': 'Starting with Amendment 5, all participants will receive open-label upadacitinib 15 mg once daily, including those currently on upadacitinib 30 mg once daily', 'otherNumAtRisk': 205, 'deathsNumAtRisk': 205, 'otherNumAffected': 82, 'seriousNumAtRisk': 205, 'deathsNumAffected': 4, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 17, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 27, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 50, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 45, 'numAffected': 40}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 33, 'numAffected': 32}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Latent tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 79, 'numAffected': 56}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 65, 'numAffected': 38}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 64, 'numAffected': 38}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 66, 'numAffected': 46}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 69, 'numAffected': 43}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 87, 'numAffected': 47}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 27, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 34, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 29, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 9, 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'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 60, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 39, 'numAffected': 29}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 311, 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'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bone marrow oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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{'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Superficial vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '34.6', 'upperLimit': '47.8'}, {'value': '67.7', 'groupId': 'OG001', 'lowerLimit': '61.5', 'upperLimit': '74.0'}, {'value': '71.2', 'groupId': 'OG002', 'lowerLimit': '65.1', 'upperLimit': '77.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.5', 'ciLowerLimit': '17.5', 'ciUpperLimit': '35.6', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Response Rate Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.0', 'ciLowerLimit': '21.0', 'ciUpperLimit': '38.9', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Response Rate Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 14', 'description': 'The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 14. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:\n\n1. ≥ 20% improvement in 68-tender joint count;\n2. ≥ 20% improvement in 66-swollen joint count; and\n3. ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Physician global assessment of disease activity\n * Patient global assessment of disease activity\n * Patient assessment of pain\n * Health Assessment Questionnaire - Disability Index (HAQ-DI)\n * High-sensitivity C-reactive protein (hsCRP).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants who prematurely discontinued from study drug prior to Week 14 or for whom ACR data were missing at Week 14 were considered non-responders.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '24.7'}, {'value': '44.7', 'groupId': 'OG001', 'lowerLimit': '38.1', 'upperLimit': '51.3'}, {'value': '53.0', 'groupId': 'OG002', 'lowerLimit': '46.4', 'upperLimit': '59.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.3', 'ciLowerLimit': '16.8', 'ciUpperLimit': '33.7', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Response Rate Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.6', 'ciLowerLimit': '25.1', 'ciUpperLimit': '42.1', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Response Rate Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 14', 'description': "The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at Week 14.\n\nThe DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.\n\nA DAS28 score less than or equal to 3.2 indicates low disease activity.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants who prematurely discontinued from study drug prior to Week 14 or for whom DAS28 data were missing at Week 14 were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in in Disease Activity Score 28 (CRP) at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '213', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.20', 'groupId': 'OG000', 'lowerLimit': '-1.39', 'upperLimit': '-1.01'}, {'value': '-2.29', 'groupId': 'OG001', 'lowerLimit': '-2.48', 'upperLimit': '-2.10'}, {'value': '-2.61', 'groupId': 'OG002', 'lowerLimit': '-2.80', 'upperLimit': '-2.41'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.08', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '-0.85', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of covariance (ANCOVA) model with treatment as the fixed factor, and baseline value and geographic region as the covariates.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.40', 'ciLowerLimit': '-1.64', 'ciUpperLimit': '-1.17', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 14', 'description': "The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline in DAS28 (CRP) indicates improvement in disease activity.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with available data at baseline; multiple imputation was used for missing post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Heath Assessment Questionnaire and Disability Index (HAQ-DI) at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.32', 'groupId': 'OG000', 'lowerLimit': '-0.41', 'upperLimit': '-0.23'}, {'value': '-0.65', 'groupId': 'OG001', 'lowerLimit': '-0.73', 'upperLimit': '-0.56'}, {'value': '-0.73', 'groupId': 'OG002', 'lowerLimit': '-0.82', 'upperLimit': '-0.64'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '-0.22', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '-0.30', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 14', 'description': 'The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with available data at baseline; multiple imputation was used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.32', 'groupId': 'OG000', 'lowerLimit': '3.19', 'upperLimit': '5.44'}, {'value': '8.28', 'groupId': 'OG001', 'lowerLimit': '7.17', 'upperLimit': '9.40'}, {'value': '10.19', 'groupId': 'OG002', 'lowerLimit': '9.07', 'upperLimit': '11.30'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.97', 'ciLowerLimit': '2.52', 'ciUpperLimit': '5.42', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Mixed Effect Model Repeat Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.87', 'ciLowerLimit': '4.42', 'ciUpperLimit': '7.32', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Mixed Effect Model Repeat Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 14', 'description': 'The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 14 was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '12.0'}, {'value': '28.1', 'groupId': 'OG001', 'lowerLimit': '22.1', 'upperLimit': '34.1'}, {'value': '40.5', 'groupId': 'OG002', 'lowerLimit': '33.9', 'upperLimit': '47.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.8', 'ciLowerLimit': '12.8', 'ciUpperLimit': '26.8', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Response Rate Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.1', 'ciLowerLimit': '24.6', 'ciUpperLimit': '39.7', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Response Rate Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 14', 'description': "The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.\n\nA DAS28 score less than 2.6 indicates clinical remission.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants who prematurely discontinued from study drug prior to Week 14 or for whom DAS28 data were missing at Week 14 were considered non-responders'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Duration of Morning Stiffness at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-53.03', 'groupId': 'OG000', 'lowerLimit': '-72.18', 'upperLimit': '-33.88'}, {'value': '-94.56', 'groupId': 'OG001', 'lowerLimit': '-113.57', 'upperLimit': '-75.54'}, {'value': '-102.34', 'groupId': 'OG002', 'lowerLimit': '-121.24', 'upperLimit': '-83.45'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.53', 'ciLowerLimit': '-66.56', 'ciUpperLimit': '-16.50', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Mixed Effect Model Repeat Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.31', 'ciLowerLimit': '-74.23', 'ciUpperLimit': '-24.40', 'pValueComment': 'The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.', 'estimateComment': 'Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Mixed Effect Model Repeat Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.', 'nonInferiorityComment': 'The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 14', 'description': 'Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 14 was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '20.1'}, {'value': '41.9', 'groupId': 'OG001', 'lowerLimit': '35.4', 'upperLimit': '48.5'}, {'value': '52.1', 'groupId': 'OG002', 'lowerLimit': '45.4', 'upperLimit': '58.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.7', 'ciLowerLimit': '18.5', 'ciUpperLimit': '34.8', 'pValueComment': 'This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.', 'estimateComment': 'Response Rate Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.8', 'ciLowerLimit': '28.6', 'ciUpperLimit': '45.0', 'pValueComment': 'This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.', 'estimateComment': 'Response Rate Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 14', 'description': 'Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:\n\n1. ≥ 50% improvement in 68-tender joint count;\n2. ≥ 50% improvement in 66-swollen joint count; and\n3. ≥ 50% improvement in at least 3 of the 5 following parameters:\n\n * Physician global assessment of disease activity\n * Patient global assessment of disease activity\n * Patient assessment of pain\n * Health Assessment Questionnaire - Disability Index (HAQ-DI)\n * High-sensitivity C-reactive protein (hsCRP).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants who prematurely discontinued from study drug prior to Week 14 or for whom ACR data were missing at Week 14 were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '5.0'}, {'value': '22.6', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '28.1'}, {'value': '33.0', 'groupId': 'OG002', 'lowerLimit': '26.7', 'upperLimit': '39.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.8', 'ciLowerLimit': '13.8', 'ciUpperLimit': '25.8', 'pValueComment': 'This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.', 'estimateComment': 'Response Rate Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.2', 'ciLowerLimit': '23.6', 'ciUpperLimit': '36.9', 'pValueComment': 'This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.', 'estimateComment': 'Response Rate Difference = Upadacitinib - Methotrexate', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 14', 'description': 'Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:\n\n1. ≥ 70% improvement in 68-tender joint count;\n2. ≥ 70% improvement in 66-swollen joint count; and\n3. ≥ 70% improvement in at least 3 of the 5 following parameters:\n\n * Physician global assessment of disease activity\n * Patient global assessment of disease activity\n * Patient assessment of pain\n * Health Assessment Questionnaire - Disability Index (HAQ-DI)\n * High-sensitivity C-reactive protein (hsCRP).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants who prematurely discontinued from study drug prior to Week 14 or for whom ACR data were missing at Week 14 were considered non-responders.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Period 1: Methotrexate', 'description': 'Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily (QD) for 14 weeks in Period 1.'}, {'id': 'FG001', 'title': 'Period 1: Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'FG002', 'title': 'Period 1: Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'FG003', 'title': 'Period 2: Upadacitinib 15 mg', 'description': 'Continuing Period 1 participants that were randomized into the upadacitinib 15 mg once daily arm combined with Period 1 Methotrexate (MTX) participants that were randomized to receive upadacitinib 15 mg once daily in Period 2'}, {'id': 'FG004', 'title': 'Period 2: Upadacitinib 30 mg', 'description': 'Continuing Period 1 participants that were randomized into the upadacitinib 30 mg once daily arm combined with Period 1 Methotrexate (MTX) participants that were randomized to receive upadacitinib 30 mg once daily in Period 2'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '216'}, {'groupId': 'FG001', 'numSubjects': '217'}, {'groupId': 'FG002', 'numSubjects': '215'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Completed Period 1 (Week 14) study participation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '201'}, {'groupId': 'FG002', 'numSubjects': '205'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '302'}, {'groupId': 'FG004', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '184'}, {'groupId': 'FG004', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '118'}, {'groupId': 'FG004', 'numSubjects': '120'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '34'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '44'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'COVID-19 Related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '31'}]}]}], 'recruitmentDetails': 'A total of 648 participants with rheumatoid arthritis (RA) on a stable dose of methotrexate (MTX) were randomized at 138 study sites located in 24 countries.', 'preAssignmentDetails': 'Participants were randomized in a 2:2:1:1 ratio to 1 of 4 groups:\n\n* Upadacitinib 30 mg (Periods 1 and 2)\n* Upadacitinib 15 mg (Periods 1 and 2)\n* MTX (Period 1) → upadacitinib 30 mg (Period 2)\n* MTX (Period 1) → upadacitinib 15 mg (Period 2)\n\nRandomization was stratified by geographic region. The MTX groups were pooled for Week 14 analyses.\n\nStarting with Amend. 5 \\& during Period 2, all participants received open-label upadacitinib 15 mg, including participants receiving upadacitinib 30 mg'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '648', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Methotrexate', 'description': 'Participants randomized to receive up to 25 mg methotrexate once a week and placebo to upadacitinib once daily for 14 weeks in Period 1.'}, {'id': 'BG001', 'title': 'Upadacitinib 15 mg', 'description': 'Participants randomized to receive upadacitinib 15 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'BG002', 'title': 'Upadacitinib 30 mg', 'description': 'Participants randomized to receive upadacitinib 30 mg once daily and placebo to methotrexate once a week for 14 weeks in Period 1.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '55.3', 'spread': '11.12', 'groupId': 'BG000'}, {'value': '54.5', 'spread': '12.20', 'groupId': 'BG001'}, {'value': '53.1', 'spread': '12.72', 'groupId': 'BG002'}, {'value': '54.3', 'spread': '12.05', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '648', 'groupId': 'BG003'}]}], 'categories': [{'title': '< 40 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': '40 - 64 years', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}, {'value': '436', 'groupId': 'BG003'}]}, {'title': '≥ 65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '648', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '648', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}, {'value': '492', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '648', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '529', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'American Indian/Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}, {'title': 'Multiple', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Geographic Region', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '648', 'groupId': 'BG003'}]}], 'categories': [{'title': 'North America', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}, {'title': 'South/Central America', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}, {'title': 'Western Europe', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Eastern Europe', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}, {'title': 'Asia - Japan', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Other includes South Africa, Turkey, and Israel.', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of RA Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '6.63', 'groupId': 'BG000'}, {'value': '7.5', 'spread': '8.88', 'groupId': 'BG001'}, {'value': '6.5', 'spread': '6.98', 'groupId': 'BG002'}, {'value': '6.6', 'spread': '7.58', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tender Joint Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '25.2', 'spread': '15.99', 'groupId': 'BG000'}, {'value': '24.5', 'spread': '15.10', 'groupId': 'BG001'}, {'value': '24.8', 'spread': '15.19', 'groupId': 'BG002'}, {'value': '24.8', 'spread': '15.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'A total of 68 joints were assessed for the presence or absence of tenderness.', 'unitOfMeasure': 'joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Swollen Joint Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '16.9', 'spread': '11.52', 'groupId': 'BG000'}, {'value': '16.4', 'spread': '10.94', 'groupId': 'BG001'}, {'value': '16.9', 'spread': '10.23', 'groupId': 'BG002'}, {'value': '16.7', 'spread': '10.90', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'A total of 66 joints were assessed for the presence or absence of swelling.', 'unitOfMeasure': 'joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Patient's Assessment of Pain", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '647', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '62.5', 'spread': '21.26', 'groupId': 'BG000'}, {'value': '62.3', 'spread': '22.53', 'groupId': 'BG001'}, {'value': '61.9', 'spread': '22.12', 'groupId': 'BG002'}, {'value': '62.3', 'spread': '21.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale (VAS) from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain."', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': "Patient's Global Assessment of Disease Activity", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '647', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '59.6', 'spread': '21.78', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '22.29', 'groupId': 'BG001'}, {'value': '59.4', 'spread': '22.79', 'groupId': 'BG002'}, {'value': '60.4', 'spread': '22.29', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': "Physician's Global Assessment of Disease Activity", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '611', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '62.1', 'spread': '17.47', 'groupId': 'BG000'}, {'value': '65.7', 'spread': '18.49', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '17.81', 'groupId': 'BG002'}, {'value': '63.5', 'spread': '17.98', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a VAS scale from 0 to 100 mm, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.", 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '647', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.66', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '0.66', 'groupId': 'BG001'}, {'value': '1.5', 'spread': '0.65', 'groupId': 'BG002'}, {'value': '1.5', 'spread': '0.66', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'High-sensitivity C-reactive Protein (hsCRP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '14.5', 'spread': '17.33', 'groupId': 'BG000'}, {'value': '14.0', 'spread': '16.49', 'groupId': 'BG001'}, {'value': '16.3', 'spread': '20.77', 'groupId': 'BG002'}, {'value': '14.9', 'spread': '18.28', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease Activity Score 28 Based on CRP (DAS28[CRP])', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '647', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.04', 'groupId': 'BG000'}, {'value': '5.6', 'spread': '0.92', 'groupId': 'BG001'}, {'value': '5.6', 'spread': '1.06', 'groupId': 'BG002'}, {'value': '5.6', 'spread': '1.01', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L).\n\nScores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28 score \\> 5.1 indicates high disease activity, a DAS28 score ≤ 3.2 indicates low disease activity, and a DAS28 score \\< 2.6 indicates clinical remission.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}], 'populationDescription': 'The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-04', 'size': 1746250, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-21T16:04', 'hasProtocol': True}, {'date': '2020-12-17', 'size': 774715, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-21T16:05', 'hasProtocol': False}]}}, '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': 648}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'dispFirstSubmitDate': '2018-09-26', 'completionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2016-02-18', 'dispFirstSubmitQcDate': '2018-09-26', 'resultsFirstSubmitDate': '2019-09-13', 'studyFirstSubmitQcDate': '2016-03-08', 'dispFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-13', 'studyFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14', 'timeFrame': 'Baseline and week 14', 'description': 'The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 14. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:\n\n1. ≥ 20% improvement in 68-tender joint count;\n2. ≥ 20% improvement in 66-swollen joint count; and\n3. ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Physician global assessment of disease activity\n * Patient global assessment of disease activity\n * Patient assessment of pain\n * Health Assessment Questionnaire - Disability Index (HAQ-DI)\n * High-sensitivity C-reactive protein (hsCRP).'}, {'measure': 'Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 14', 'timeFrame': 'Week 14', 'description': "The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at Week 14.\n\nThe DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.\n\nA DAS28 score less than or equal to 3.2 indicates low disease activity."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in in Disease Activity Score 28 (CRP) at Week 14', 'timeFrame': 'Baseline to week 14', 'description': "The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline in DAS28 (CRP) indicates improvement in disease activity."}, {'measure': 'Change From Baseline in Heath Assessment Questionnaire and Disability Index (HAQ-DI) at Week 14', 'timeFrame': 'Baseline to week 14', 'description': 'The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.'}, {'measure': 'Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 14', 'timeFrame': 'Baseline to week 14', 'description': 'The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).\n\nThe physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.'}, {'measure': 'Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 14', 'timeFrame': 'Week 14', 'description': "The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.\n\nA DAS28 score less than 2.6 indicates clinical remission."}, {'measure': 'Change From Baseline in Duration of Morning Stiffness at Week 14', 'timeFrame': 'Baseline to week 14', 'description': 'Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.'}, {'measure': 'Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 14', 'timeFrame': 'Baseline and week 14', 'description': 'Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:\n\n1. ≥ 50% improvement in 68-tender joint count;\n2. ≥ 50% improvement in 66-swollen joint count; and\n3. ≥ 50% improvement in at least 3 of the 5 following parameters:\n\n * Physician global assessment of disease activity\n * Patient global assessment of disease activity\n * Patient assessment of pain\n * Health Assessment Questionnaire - Disability Index (HAQ-DI)\n * High-sensitivity C-reactive protein (hsCRP).'}, {'measure': 'Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 14', 'timeFrame': 'Baseline and week 14', 'description': 'Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:\n\n1. ≥ 70% improvement in 68-tender joint count;\n2. ≥ 70% improvement in 66-swollen joint count; and\n3. ≥ 70% improvement in at least 3 of the 5 following parameters:\n\n * Physician global assessment of disease activity\n * Patient global assessment of disease activity\n * Patient assessment of pain\n * Health Assessment Questionnaire - Disability Index (HAQ-DI)\n * High-sensitivity C-reactive protein (hsCRP).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Musculoskeletal Disease', 'Arthritis', 'Joint Disease', 'Anti-inflammatory agents', 'Antirheumatic agents', 'Upadacitinib', 'ABT-494'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '31130260', 'type': 'BACKGROUND', 'citation': 'Smolen JS, Pangan AL, Emery P, Rigby W, Tanaka Y, Vargas JI, Zhang Y, Damjanov N, Friedman A, Othman AA, Camp HS, Cohen S. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019 Jun 8;393(10188):2303-2311. doi: 10.1016/S0140-6736(19)30419-2. Epub 2019 May 23.'}, {'pmid': '40875187', 'type': 'DERIVED', 'citation': 'Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.'}, {'pmid': '40350200', 'type': 'DERIVED', 'citation': 'Smolen JS, Emery P, Rigby W, Tanaka Y, Vargas JI, Jain M, Kato K, Carter KM, Khan N, Phillips C, Meerwein S, Cohen SB. Upadacitinib as monotherapy in patients with rheumatoid arthritis and prior inadequate response to methotrexate: results at 260 weeks from the SELECT-MONOTHERAPY randomised study. RMD Open. 2025 May 11;11(2):e005051. doi: 10.1136/rmdopen-2024-005051.'}, {'pmid': '37982966', 'type': 'DERIVED', 'citation': 'Rubbert-Roth A, Kakehasi AM, Takeuchi T, Schmalzing M, Palac H, Coombs D, Liu J, Anyanwu SI, Lippe R, Curtis JR. Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Feb;11(1):97-112. doi: 10.1007/s40744-023-00621-6. Epub 2023 Nov 20.'}, {'pmid': '37945286', 'type': 'DERIVED', 'citation': 'Charles-Schoeman C, Choy E, McInnes IB, Mysler E, Nash P, Yamaoka K, Lippe R, Khan N, Shmagel AK, Palac H, Suboticki J, Curtis JR. MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. RMD Open. 2023 Nov;9(4):e003392. doi: 10.1136/rmdopen-2023-003392.'}, {'pmid': '37308218', 'type': 'DERIVED', 'citation': 'Fleischmann R, Curtis JR, Charles-Schoeman C, Mysler E, Yamaoka K, Richez C, Palac H, Dilley D, Liu J, Strengholt S, Burmester G. Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme. Ann Rheum Dis. 2023 Sep;82(9):1130-1141. doi: 10.1136/ard-2023-223916. Epub 2023 Jun 12.'}, {'pmid': '36794283', 'type': 'DERIVED', 'citation': 'Conaghan PG, Pavelka K, Hsieh SC, Bonnington TL, Kent TC, Marchbank K, Edwards CJ. Evaluating the efficacy of upadacitinib in patients with moderate rheumatoid arthritis: a post-hoc analysis of the SELECT phase 3 trials. Rheumatol Adv Pract. 2023 Feb 8;7(1):rkad017. doi: 10.1093/rap/rkad017. eCollection 2023.'}, {'pmid': '36754548', 'type': 'DERIVED', 'citation': 'Burmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.'}, {'pmid': '36715850', 'type': 'DERIVED', 'citation': 'Kakehasi AM, Radominski SC, Baravalle MD, Palazuelos FCI, Garcia-Garcia C, Arruda MS, Curi M, Liu J, Qiao M, Velez-Sanchez P, Vargas JI. Safety of upadacitinib in Latin American patients with rheumatoid arthritis: an integrated safety analysis of the SELECT phase 3 clinical program. Clin Rheumatol. 2023 May;42(5):1249-1258. doi: 10.1007/s10067-023-06513-y. Epub 2023 Jan 30.'}, {'pmid': '36125701', 'type': 'DERIVED', 'citation': 'Bergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20.'}, {'pmid': '34636000', 'type': 'DERIVED', 'citation': 'Bergman M, Tundia N, Yang M, Orvis E, Clewell J, Bensimon A. Economic Benefit from Improvements in Quality of Life with Upadacitinib: Comparisons with Tofacitinib and Methotrexate in Patients with Rheumatoid Arthritis. Adv Ther. 2021 Dec;38(12):5649-5661. doi: 10.1007/s12325-021-01930-4. Epub 2021 Oct 12.'}, {'pmid': '34041702', 'type': 'DERIVED', 'citation': 'Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.'}, {'pmid': '33313898', 'type': 'DERIVED', 'citation': 'Strand V, Tundia N, Wells A, Buch MH, Radominski SC, Camp HS, Friedman A, Suboticki JL, Dunlap K, Goldschmidt D, Bergman M. Upadacitinib monotherapy improves patient-reported outcomes in rheumatoid arthritis: results from SELECT-EARLY and SELECT-MONOTHERAPY. Rheumatology (Oxford). 2021 Jul 1;60(7):3209-3221. doi: 10.1093/rheumatology/keaa770.'}, {'pmid': '33115760', 'type': 'DERIVED', 'citation': 'Cohen SB, van Vollenhoven RF, Winthrop KL, Zerbini CAF, Tanaka Y, Bessette L, Zhang Y, Khan N, Hendrickson B, Enejosa JV, Burmester GR. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2021 Mar;80(3):304-311. doi: 10.1136/annrheumdis-2020-218510. Epub 2020 Oct 28.'}, {'pmid': '31610021', 'type': 'DERIVED', 'citation': 'Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.'}], 'seeAlsoLinks': [{'url': 'https://www.rxabbvie.com/', 'label': 'Related Info.'}]}, 'descriptionModule': {'briefSummary': 'The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX.\n\nThe study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.', 'detailedDescription': 'The study includes a 35-day screening period; a 14-week randomized, double-blind, parallel-group, controlled treatment period (Period 1); a 246-week blinded extension period (Period 2); and a 30-day follow-up visit.\n\nParticipants who met eligibility criteria were to be randomized in a 2:2:1:1 ratio to one of four treatment groups:\n\n* Group 1: upadacitinib 30 mg QD (Period 1) → upadacitinib 30 mg QD (Period 2)\n* Group 2: upadacitinib 15 mg QD (Period 1) → upadacitinib 15 mg QD (Period 2)\n* Group 3: MTX (Period 1) → upadacitinib 30 mg QD (Period 2)\n* Group 4: MTX (Period 1) → upadacitinib 15 mg QD (Period 2)\n\nStarting with implementation of Protocol Amendment 5, all participants in the extension period will receive open-label upadacitinib 15 mg QD, including those currently on upadacitinib 30 mg QD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of RA for \\>= 3 months.\n* Subjects must have been on oral or parenteral MTX therapy \\>= 3 months and on a stable dose for \\>= 4 weeks prior to first dose of study drug.\n* Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) \\>= 4 weeks prior to first dose of study drug.\n* Meets the following minimum disease activity criteria: \\>= 6 swollen joints (based on 66 joint counts) and \\>= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.\n\nExclusion Criteria:\n\n* Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).\n* Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).\n* Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted."}, 'identificationModule': {'nctId': 'NCT02706951', 'briefTitle': 'A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX', 'orgStudyIdInfo': {'id': 'M15-555'}, 'secondaryIdInfos': [{'id': '2015-003376-75', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Upadacitinib 30 mg', 'description': 'Period 1: Participants receive upadacitnib 30 mg once daily and placebo to methotrexate once weekly for 14 weeks.\n\nPeriod 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.', 'interventionNames': ['Drug: Upadacitinib', 'Drug: Placebo Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Upadacitinib 15 mg', 'description': 'Period 1: Participants receive upadacitnib 15 mg once daily and placebo to methotrexate once weekly for 14 weeks.\n\nPeriod 2: Participants receive upadacitinib 15 mg once daily up to Week 260.', 'interventionNames': ['Drug: Upadacitinib', 'Drug: Placebo Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Methotrexate / Upadacitinib 30 mg', 'description': 'Period 1: Participants receive methotrexate once weekly and placebo to upadacitinib once daily for 14 weeks.\n\nPeriod 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.', 'interventionNames': ['Drug: Methotrexate', 'Drug: Upadacitinib', 'Drug: Placebo Upadacitinib', 'Drug: Placebo Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Methotrexate / Upadacitinib 15 mg', 'description': 'Period 1: Participants receive methotrexate once weekly and placebo to upadacitinib for 14 weeks.\n\nPeriod 2: Participants receive upadacitinib 15 mg once daily up to Week 260.', 'interventionNames': ['Drug: Methotrexate', 'Drug: Upadacitinib', 'Drug: Placebo Upadacitinib', 'Drug: Placebo Methotrexate']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Capsule; Oral', 'armGroupLabels': ['Methotrexate / Upadacitinib 15 mg', 'Methotrexate / Upadacitinib 30 mg']}, {'name': 'Upadacitinib', 'type': 'DRUG', 'otherNames': ['ABT-494', 'Rinvoq'], 'description': 'Tablet; Oral', 'armGroupLabels': ['Methotrexate / Upadacitinib 15 mg', 'Methotrexate / Upadacitinib 30 mg', 'Upadacitinib 15 mg', 'Upadacitinib 30 mg']}, {'name': 'Placebo Upadacitinib', 'type': 'DRUG', 'description': 'Tablet; Oral', 'armGroupLabels': ['Methotrexate / Upadacitinib 15 mg', 'Methotrexate / Upadacitinib 30 mg']}, {'name': 'Placebo Methotrexate', 'type': 'DRUG', 'description': 'Capsule; Oral', 'armGroupLabels': ['Methotrexate / Upadacitinib 15 mg', 'Methotrexate / Upadacitinib 30 mg', 'Upadacitinib 15 mg', 'Upadacitinib 30 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Rheum Assoc of North Alabama /ID# 146009', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608-1787', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Medical Group, PC /ID# 153941', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'ArthroCare Arthritis Care & Re /ID# 143751', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Elite Clinical Studies, LLC /ID# 143760', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719-1478', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Cancer Center - North Campus /ID# 147175', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Baptist Womens Clinic /ID# 148904', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '92543', 'city': 'Hemet', 'state': 'California', 'country': 'United States', 'facility': 'C.V. Mehta MD, Med Corporation /ID# 143762', 'geoPoint': {'lat': 33.74761, 'lon': -116.97307}}, {'zip': '80920', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Arthritis Assoc & Osteo Ctr /ID# 147176', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33309', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Ctr Rheum, Immuno, Arthritis /ID# 143766', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33166-7225', 'city': 'Miami Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Research Ph I-IV /ID# 151983', 'geoPoint': {'lat': 25.82232, 'lon': -80.2895}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Clinical Research /ID# 143767', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Arthritis Center /ID# 146011', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'W. 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'Iizuka-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Aso Iizuka Hospital /ID# 148272'}, {'zip': '3700053', 'city': 'Takasaki', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Inoue Hospital /ID# 148069', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'zip': '781-0112', 'city': 'Kochi', 'state': 'Kochi', 'country': 'Japan', 'facility': 'Bay Side Misato Medical Center /ID# 148281', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'zip': '862-0920', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Center for Arthritis and Clinical Rheumatology Matsubara Clinic /ID# 148269', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '8628655', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto Shinto General Hospital /ID# 148286', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '852-8501', 'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Nagasaki University Hospital /ID# 149859', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '857-1195', 'city': 'Sasebo', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Sasebo Chuo Hospital /ID# 148275', 'geoPoint': {'lat': 33.16834, 'lon': 129.72502}}, {'zip': '543-8555', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Red Cross Hospital /ID# 148267', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '430-8558', 'city': 'Hamamatsu', 'country': 'Japan', 'facility': 'Seirei Hamamatsu General Hosp /ID# 148270', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '883-0043', 'city': 'Hyūga', 'country': 'Japan', 'facility': 'Ohira Orthopaedic Hospital /ID# 157944', 'geoPoint': {'lat': 32.42272, 'lon': 131.64093}}, {'zip': '649-2211', 'city': 'Nishimura', 'country': 'Japan', 'facility': 'Shirahama Hamayu Hospital /ID# 148277', 'geoPoint': {'lat': 37.84727, 'lon': 136.91725}}, {'zip': '769-2321', 'city': 'Sanuki', 'country': 'Japan', 'facility': 'Sanuki Municipal Hospital /ID# 158080', 'geoPoint': {'lat': 35.26319, 'lon': 139.889}}, {'zip': '060-8648', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'Hokkaido University Hospital /ID# 148285', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '063-0811', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'Hokkaido Medical Center for Rheumatic Diseases /ID# 148274', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '745-0824', 'city': 'Shūnan', 'country': 'Japan', 'facility': 'Miyasato Clinic /ID# 148271', 'geoPoint': {'lat': 34.08053, 'lon': 131.82564}}, {'zip': '933-0874', 'city': 'Takaoka', 'country': 'Japan', 'facility': 'Takaoka Rheumatic Orthopedic Clinic /ID# 148068', 'geoPoint': {'lat': 36.75, 'lon': 137.01667}}, {'zip': '155-0032', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Matsuta Clinic /ID# 148278', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '284-0003', 'city': 'Yotsukaidō', 'country': 'Japan', 'facility': 'National Hospital Organization Shimoshizu National Hospital /ID# 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Bielicka, A. Strzalkowska s.c. /ID# 157622', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '20-607', 'city': 'Lublin', 'state': 'Lublin Voivodeship', 'country': 'Poland', 'facility': 'REUMED Sp.z o.o. Filia nr 1 /ID# 144752', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '02-507', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149521', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '15-351', 'city': 'Bialystok', 'state': 'Podlaskie Voivodeship', 'country': 'Poland', 'facility': 'Osteo-Medic spolka cywilna /ID# 144753', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '80-546', 'city': 'Gdansk', 'state': 'Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Centrum Badań Klinicznych Pi-House /ID# 149520', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '82-300', 'city': 'Elblag', 'state': 'Warmian-Masurian Voivodeship', 'country': 'Poland', 'facility': 'NZOZ Centrum Reumatologiczne /ID# 144749', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'zip': '1050-034', 'city': 'Lisbon', 'state': 'Lisbon District', 'country': 'Portugal', 'facility': 'Instituto Portugues De Reumatologia /ID# 149281', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4434-502', 'city': 'Vila Nova de Gaia', 'state': 'Porto District', 'country': 'Portugal', 'facility': 'Centro Hospitalar De Vila Nova /ID# 146036', 'geoPoint': {'lat': 41.12401, 'lon': -8.61241}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Centro Hospitalar Lisboa Norte, EPE /ID# 146035', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4050-111', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Centro Hospitalar Baixo Vouga /ID# 152916', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '00983', 'city': 'Carolina', 'country': 'Puerto Rico', 'facility': 'Dr. Ramon L. Ortega-Colon, MD /ID# 145989', 'geoPoint': {'lat': 18.38078, 'lon': -65.95739}}, {'zip': '00716', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Ponce School of Medicine /ID# 145990', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '100337', 'city': 'Ploieşti', 'country': 'Romania', 'facility': 'Spitalul Municipal Ploiesti /ID# 144756', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'zip': '119049', 'city': 'Moscow', 'state': 'Moscow', 'country': 'Russia', 'facility': 'Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 147255', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '630099', 'city': 'Novosibirsk', 'state': 'Novosibirsk Oblast', 'country': 'Russia', 'facility': 'LLC Medical Center /ID# 144758', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '614109', 'city': 'Perm', 'state': 'Permskiy Kray', 'country': 'Russia', 'facility': 'Perm Clinical Center of FMBA /ID# 145993', 'geoPoint': {'lat': 58.01046, 'lon': 56.25017}}, {'zip': '170036', 'city': "Tver'", 'state': 'Tver Oblast', 'country': 'Russia', 'facility': 'Tver Regional Clinical Hosp. /ID# 147254', 'geoPoint': {'lat': 56.85836, 'lon': 35.90057}}, {'zip': '153005', 'city': 'Ivanovo', 'country': 'Russia', 'facility': 'Сity Clinical Hospital 4 /ID# 145994', 'geoPoint': {'lat': 56.99988, 'lon': 40.97257}}, {'zip': '125284', 'city': 'Moscow', 'country': 'Russia', 'facility': 'City Clinical Hospital Botkina /ID# 145995', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603005', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'City Clinical Hospital #5 /ID# 149832', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '460000', 'city': 'Orenburg', 'country': 'Russia', 'facility': 'Orenburg State Medical Academy /ID# 145992', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'zip': '185019', 'city': 'Petrozavodsk', 'country': 'Russia', 'facility': 'Republican Clin Hos n.a. Baran /ID# 147251', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'zip': '443095', 'city': 'Samara', 'country': 'Russia', 'facility': 'Samara Regional Clinical Hosp /ID# 150934', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '450005', 'city': 'Ufa', 'country': 'Russia', 'facility': 'Reg Clin Hosp n.a. Kuvatova G. /ID# 144757', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '150000', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Yaroslavi State Medical Univer /ID# 147253', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '11000', 'city': 'Belgrade', 'state': 'Beograd', 'country': 'Serbia', 'facility': 'Institute for Rheumatology /ID# 144759', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'state': 'Beograd', 'country': 'Serbia', 'facility': 'Institute for Rheumatology /ID# 144761', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'state': 'Beograd', 'country': 'Serbia', 'facility': 'Institute for Rheumatology /ID# 144762', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '21000', 'city': 'Novi Sad', 'state': 'Vojvodina', 'country': 'Serbia', 'facility': 'Special Hospital for Rheuma /ID# 144760', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}, {'zip': '2193', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Wits Clinical Research Site /ID# 149835', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '0001', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'University of Pretoria /ID# 148740', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '7130', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Synexus Helderberg Clinical Tr /ID# 148724', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7530', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Tiervlei Trial Centre /ID# 153086', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '08006', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Plató /ID# 145999', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08916', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Univ Germans Trias I /ID# 146037', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '41010', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Infanta Luisa /ID# 144771', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41014', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario de Valm /ID# 144770', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario La Fe /ID# 158013', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '16080', 'city': 'Osmangazi', 'state': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Uludağ Üniversitesi Atatürk Rehabilitasyon Uygulama ve Araştırma Merkezi /ID# 144772', 'geoPoint': {'lat': 40.24704, 'lon': 29.01901}}, {'zip': '79013', 'city': 'Lviv', 'state': 'Lviv Oblast', 'country': 'Ukraine', 'facility': 'Lviv Regional Clinical Hospita /ID# 154448', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '21018', 'city': 'Vinnytsia', 'state': 'Vinnytsia Oblast', 'country': 'Ukraine', 'facility': 'Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 146002', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '76018', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Regional Clinical Hospital /ID# 152007', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '03680', 'city': 'Kiev', 'country': 'Ukraine', 'facility': 'NSC-Strazhesko Ist Cardiology /ID# 152004', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '69600', 'city': 'Zaporizhia', 'country': 'Ukraine', 'facility': 'Zaporizhzhia Regional Clinical /ID# 146000'}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}