Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-02 @ 8:29 PM
Study NCT ID:
NCT03682705
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2018-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'Ireland'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613732', 'term': 'upadacitinib'}]}}, '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': 'Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 16 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.', 'description': 'TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.', 'eventGroups': [{'id': 'EG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 10, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 7, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 17, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 10, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 8, 'seriousNumAtRisk': 41, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 9, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'PERIPHERAL SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'TOOTH INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'ANIMAL BITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'BLOOD GLUCOSE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'VITAMIN D DEFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'BONE DEFORMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'RHEUMATOID ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'ENDOMETRIAL ADENOCARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'PYELONEPHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'CLAVICLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'RIB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'ROAD TRAFFIC ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'PROSTATIC SPECIFIC ANTIGEN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'LUMBAR RADICULOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.12', 'groupId': 'OG000', 'lowerLimit': '-1.64', 'upperLimit': '-0.60'}, {'value': '-2.56', 'groupId': 'OG001', 'lowerLimit': '-2.86', 'upperLimit': '-2.26'}, {'value': '-1.52', 'groupId': 'OG002', 'lowerLimit': '-1.89', 'upperLimit': '-1.15'}, {'value': '-1.32', 'groupId': 'OG003', 'lowerLimit': '-1.71', 'upperLimit': '-0.93'}, {'value': '-1.33', 'groupId': 'OG004', 'lowerLimit': '-1.70', 'upperLimit': '-0.97'}, {'value': '-2.87', 'groupId': 'OG005', 'lowerLimit': '-3.23', 'upperLimit': '-2.51'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.44', 'ciLowerLimit': '-2.03', 'ciUpperLimit': '-0.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': 'Mixed-Effect Model Repeated Measure (MMRM) analysis was conducted, testing the superiority of the combination of upadacitinib 15 mg and elsubrutinib 60 mg compared to placebo at Week 12. Data collected after a participant discontinued study drug was considered as missing. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline DAS28 (CRP) measurement.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', '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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Disease Activity Index (CDAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-6.08', 'groupId': 'OG000', 'lowerLimit': '-10.48', 'upperLimit': '-1.67'}, {'value': '-16.00', 'groupId': 'OG001', 'lowerLimit': '-18.53', 'upperLimit': '-13.47'}, {'value': '-8.95', 'groupId': 'OG002', 'lowerLimit': '-11.99', 'upperLimit': '-5.91'}, {'value': '-7.36', 'groupId': 'OG003', 'lowerLimit': '-10.44', 'upperLimit': '-4.27'}, {'value': '-8.38', 'groupId': 'OG004', 'lowerLimit': '-11.48', 'upperLimit': '-5.28'}, {'value': '-14.03', 'groupId': 'OG005', 'lowerLimit': '-17.04', 'upperLimit': '-11.02'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-11.60', 'groupId': 'OG000', 'lowerLimit': '-16.38', 'upperLimit': '-6.82'}, {'value': '-20.24', 'groupId': 'OG001', 'lowerLimit': '-22.97', 'upperLimit': '-17.50'}, {'value': '-11.67', 'groupId': 'OG002', 'lowerLimit': '-15.01', 'upperLimit': '-8.34'}, {'value': '-10.10', 'groupId': 'OG003', 'lowerLimit': '-13.50', 'upperLimit': '-6.70'}, {'value': '-12.90', 'groupId': 'OG004', 'lowerLimit': '-16.22', 'upperLimit': '-9.58'}, {'value': '-20.30', 'groupId': 'OG005', 'lowerLimit': '-23.57', 'upperLimit': '-17.03'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-12.46', 'groupId': 'OG000', 'lowerLimit': '-17.52', 'upperLimit': '-7.40'}, {'value': '-24.95', 'groupId': 'OG001', 'lowerLimit': '-27.86', 'upperLimit': '-22.05'}, {'value': '-15.07', 'groupId': 'OG002', 'lowerLimit': '-18.65', 'upperLimit': '-11.49'}, {'value': '-17.10', 'groupId': 'OG003', 'lowerLimit': '-20.83', 'upperLimit': '-13.38'}, {'value': '-14.84', 'groupId': 'OG004', 'lowerLimit': '-18.42', 'upperLimit': '-11.26'}, {'value': '-23.72', 'groupId': 'OG005', 'lowerLimit': '-27.20', 'upperLimit': '-20.24'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-14.57', 'groupId': 'OG000', 'lowerLimit': '-19.77', 'upperLimit': '-9.36'}, {'value': '-27.00', 'groupId': 'OG001', 'lowerLimit': '-30.05', 'upperLimit': '-23.95'}, {'value': '-17.50', 'groupId': 'OG002', 'lowerLimit': '-21.22', 'upperLimit': '-13.78'}, {'value': '-16.70', 'groupId': 'OG003', 'lowerLimit': '-20.62', 'upperLimit': '-12.78'}, {'value': '-16.51', 'groupId': 'OG004', 'lowerLimit': '-20.27', 'upperLimit': '-12.75'}, {'value': '-28.85', 'groupId': 'OG005', 'lowerLimit': '-32.48', 'upperLimit': '-25.21'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from baseline indicates improvement in disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Simplified Disease Activity Index (SDAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-6.17', 'groupId': 'OG000', 'lowerLimit': '-10.67', 'upperLimit': '-1.67'}, {'value': '-17.01', 'groupId': 'OG001', 'lowerLimit': '-19.60', 'upperLimit': '-14.43'}, {'value': '-8.79', 'groupId': 'OG002', 'lowerLimit': '-11.89', 'upperLimit': '-5.68'}, {'value': '-7.42', 'groupId': 'OG003', 'lowerLimit': '-10.57', 'upperLimit': '-4.26'}, {'value': '-8.54', 'groupId': 'OG004', 'lowerLimit': '-11.71', 'upperLimit': '-5.38'}, {'value': '-15.30', 'groupId': 'OG005', 'lowerLimit': '-18.37', 'upperLimit': '-12.22'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-11.80', 'groupId': 'OG000', 'lowerLimit': '-16.67', 'upperLimit': '-6.93'}, {'value': '-21.24', 'groupId': 'OG001', 'lowerLimit': '-24.02', 'upperLimit': '-18.45'}, {'value': '-11.46', 'groupId': 'OG002', 'lowerLimit': '-14.85', 'upperLimit': '-8.06'}, {'value': '-10.15', 'groupId': 'OG003', 'lowerLimit': '-13.61', 'upperLimit': '-6.68'}, {'value': '-12.87', 'groupId': 'OG004', 'lowerLimit': '-16.25', 'upperLimit': '-9.49'}, {'value': '-21.59', 'groupId': 'OG005', 'lowerLimit': '-24.92', 'upperLimit': '-18.26'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-12.15', 'groupId': 'OG000', 'lowerLimit': '-17.35', 'upperLimit': '-6.95'}, {'value': '-25.96', 'groupId': 'OG001', 'lowerLimit': '-28.95', 'upperLimit': '-22.98'}, {'value': '-15.26', 'groupId': 'OG002', 'lowerLimit': '-18.94', 'upperLimit': '-11.57'}, {'value': '-17.32', 'groupId': 'OG003', 'lowerLimit': '-21.17', 'upperLimit': '-13.46'}, {'value': '-15.21', 'groupId': 'OG004', 'lowerLimit': '-18.89', 'upperLimit': '-11.53'}, {'value': '-25.07', 'groupId': 'OG005', 'lowerLimit': '-28.65', 'upperLimit': '-21.49'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-14.44', 'groupId': 'OG000', 'lowerLimit': '-19.84', 'upperLimit': '-9.04'}, {'value': '-28.06', 'groupId': 'OG001', 'lowerLimit': '-31.22', 'upperLimit': '-24.89'}, {'value': '-18.01', 'groupId': 'OG002', 'lowerLimit': '-21.86', 'upperLimit': '-14.15'}, {'value': '-17.12', 'groupId': 'OG003', 'lowerLimit': '-21.20', 'upperLimit': '-13.05'}, {'value': '-16.73', 'groupId': 'OG004', 'lowerLimit': '-20.65', 'upperLimit': '-12.81'}, {'value': '-29.65', 'groupId': 'OG005', 'lowerLimit': '-33.42', 'upperLimit': '-25.88'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm), global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (CRP; mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86.with higher scores indicating higher disease activity. A negative change from baseline indicates improvement in disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '3.55', 'upperLimit': '27.35'}, {'value': '32.3', 'groupId': 'OG001', 'lowerLimit': '23.41', 'upperLimit': '42.59'}, {'value': '19.5', 'groupId': 'OG002', 'lowerLimit': '11.36', 'upperLimit': '31.44'}, {'value': '7.7', 'groupId': 'OG003', 'lowerLimit': '3.12', 'upperLimit': '17.76'}, {'value': '9.8', 'groupId': 'OG004', 'lowerLimit': '4.46', 'upperLimit': '20.04'}, {'value': '42.5', 'groupId': 'OG005', 'lowerLimit': '30.52', 'upperLimit': '55.43'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', '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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '9.82', 'upperLimit': '39.50'}, {'value': '41.9', 'groupId': 'OG001', 'lowerLimit': '32.18', 'upperLimit': '52.37'}, {'value': '22.0', 'groupId': 'OG002', 'lowerLimit': '13.24', 'upperLimit': '34.13'}, {'value': '10.3', 'groupId': 'OG003', 'lowerLimit': '4.69', 'upperLimit': '20.98'}, {'value': '14.6', 'groupId': 'OG004', 'lowerLimit': '7.76', 'upperLimit': '25.89'}, {'value': '55.0', 'groupId': 'OG005', 'lowerLimit': '42.16', 'upperLimit': '67.21'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', '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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '3.55', 'upperLimit': '27.35'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '9.89', 'upperLimit': '25.20'}, {'value': '9.8', 'groupId': 'OG002', 'lowerLimit': '4.46', 'upperLimit': '20.04'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '6.49'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '0.55', 'upperLimit': '10.22'}, {'value': '12.5', 'groupId': 'OG005', 'lowerLimit': '6.22', 'upperLimit': '23.53'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '3.55', 'upperLimit': '27.35'}, {'value': '29.0', 'groupId': 'OG001', 'lowerLimit': '20.59', 'upperLimit': '39.23'}, {'value': '12.2', 'groupId': 'OG002', 'lowerLimit': '6.06', 'upperLimit': '23.01'}, {'value': '7.7', 'groupId': 'OG003', 'lowerLimit': '3.12', 'upperLimit': '17.76'}, {'value': '12.2', 'groupId': 'OG004', 'lowerLimit': '6.06', 'upperLimit': '23.01'}, {'value': '22.5', 'groupId': 'OG005', 'lowerLimit': '13.59', 'upperLimit': '34.90'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '1.18', 'upperLimit': '20.50'}, {'value': '46.8', 'groupId': 'OG001', 'lowerLimit': '36.71', 'upperLimit': '57.11'}, {'value': '17.1', 'groupId': 'OG002', 'lowerLimit': '9.53', 'upperLimit': '28.69'}, {'value': '20.5', 'groupId': 'OG003', 'lowerLimit': '11.96', 'upperLimit': '32.89'}, {'value': '24.4', 'groupId': 'OG004', 'lowerLimit': '15.17', 'upperLimit': '36.78'}, {'value': '35.0', 'groupId': 'OG005', 'lowerLimit': '23.91', 'upperLimit': '47.99'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000', 'lowerLimit': '13.44', 'upperLimit': '45.09'}, {'value': '37.1', 'groupId': 'OG001', 'lowerLimit': '27.74', 'upperLimit': '47.53'}, {'value': '34.1', 'groupId': 'OG002', 'lowerLimit': '23.29', 'upperLimit': '46.97'}, {'value': '17.9', 'groupId': 'OG003', 'lowerLimit': '10.03', 'upperLimit': '30.02'}, {'value': '17.1', 'groupId': 'OG004', 'lowerLimit': '9.53', 'upperLimit': '28.69'}, {'value': '57.5', 'groupId': 'OG005', 'lowerLimit': '44.57', 'upperLimit': '69.48'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, Week 4, Week 8, and Week 12', 'description': 'The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Low Disease Activity (LDA) based on CDAI is defined as achieving a CDAI of less than or equal to 10.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Complete Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '12.46'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '1.07', 'upperLimit': '9.29'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '6.19'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '6.49'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '6.19'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '6.34'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '12.46'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '2.93', 'upperLimit': '13.62'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '0.55', 'upperLimit': '10.22'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '0.57', 'upperLimit': '10.71'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '6.19'}, {'value': '2.5', 'groupId': 'OG005', 'lowerLimit': '0.56', 'upperLimit': '10.46'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '12.46'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '7.43', 'upperLimit': '21.48'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '2.96', 'upperLimit': '16.96'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '0.57', 'upperLimit': '10.71'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '0.55', 'upperLimit': '10.22'}, {'value': '12.5', 'groupId': 'OG005', 'lowerLimit': '6.22', 'upperLimit': '23.53'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '1.18', 'upperLimit': '20.50'}, {'value': '14.5', 'groupId': 'OG001', 'lowerLimit': '8.65', 'upperLimit': '23.35'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '2.96', 'upperLimit': '16.96'}, {'value': '5.1', 'groupId': 'OG003', 'lowerLimit': '1.71', 'upperLimit': '14.37'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '6.19'}, {'value': '15.0', 'groupId': 'OG005', 'lowerLimit': '7.96', 'upperLimit': '26.47'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, Week 4, Week 8, and Week 12', 'description': 'The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Complete Remission (CR) based on CDAI is defined as achieving a CDAI of less than or equal to 2.8.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '9.82', 'upperLimit': '39.50'}, {'value': '45.2', 'groupId': 'OG001', 'lowerLimit': '35.19', 'upperLimit': '55.54'}, {'value': '24.4', 'groupId': 'OG002', 'lowerLimit': '15.17', 'upperLimit': '36.78'}, {'value': '12.8', 'groupId': 'OG003', 'lowerLimit': '6.38', 'upperLimit': '24.08'}, {'value': '14.6', 'groupId': 'OG004', 'lowerLimit': '7.76', 'upperLimit': '25.89'}, {'value': '52.5', 'groupId': 'OG005', 'lowerLimit': '39.77', 'upperLimit': '64.91'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000', 'lowerLimit': '25.63', 'upperLimit': '60.55'}, {'value': '51.6', 'groupId': 'OG001', 'lowerLimit': '41.33', 'upperLimit': '61.76'}, {'value': '29.3', 'groupId': 'OG002', 'lowerLimit': '19.16', 'upperLimit': '41.94'}, {'value': '23.1', 'groupId': 'OG003', 'lowerLimit': '13.95', 'upperLimit': '35.70'}, {'value': '22.0', 'groupId': 'OG004', 'lowerLimit': '13.24', 'upperLimit': '34.13'}, {'value': '55.0', 'groupId': 'OG005', 'lowerLimit': '42.16', 'upperLimit': '67.21'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000', 'lowerLimit': '21.37', 'upperLimit': '55.59'}, {'value': '64.5', 'groupId': 'OG001', 'lowerLimit': '54.11', 'upperLimit': '73.71'}, {'value': '39.0', 'groupId': 'OG002', 'lowerLimit': '27.55', 'upperLimit': '51.86'}, {'value': '30.8', 'groupId': 'OG003', 'lowerLimit': '20.20', 'upperLimit': '43.84'}, {'value': '39.0', 'groupId': 'OG004', 'lowerLimit': '27.55', 'upperLimit': '51.86'}, {'value': '67.5', 'groupId': 'OG005', 'lowerLimit': '54.55', 'upperLimit': '78.23'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000', 'lowerLimit': '30.07', 'upperLimit': '65.33'}, {'value': '64.5', 'groupId': 'OG001', 'lowerLimit': '54.11', 'upperLimit': '73.71'}, {'value': '41.5', 'groupId': 'OG002', 'lowerLimit': '29.72', 'upperLimit': '54.26'}, {'value': '30.8', 'groupId': 'OG003', 'lowerLimit': '20.20', 'upperLimit': '43.84'}, {'value': '34.1', 'groupId': 'OG004', 'lowerLimit': '23.29', 'upperLimit': '46.97'}, {'value': '72.5', 'groupId': 'OG005', 'lowerLimit': '59.75', 'upperLimit': '82.40'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': "Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 20% response (ACR20) 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 * Patient's Assessment of Pain (Visual Analog Scale \\[VAS\\])\n * Patient's Global Assessment of Disease Activity (PtGA)\n * Physician's Global Assessment of Disease Activity (PhGA)\n * Health Assessment Questionnaire Disability Index (HAQ-DI)\n * High-sensitivity C-reactive protein (hsCRP)", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '12.46'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '9.89', 'upperLimit': '25.20'}, {'value': '4.9', 'groupId': 'OG002', 'lowerLimit': '1.63', 'upperLimit': '13.71'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '6.49'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '6.19'}, {'value': '12.5', 'groupId': 'OG005', 'lowerLimit': '6.22', 'upperLimit': '23.53'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '3.55', 'upperLimit': '27.35'}, {'value': '19.4', 'groupId': 'OG001', 'lowerLimit': '12.46', 'upperLimit': '28.82'}, {'value': '17.1', 'groupId': 'OG002', 'lowerLimit': '9.53', 'upperLimit': '28.69'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '0.57', 'upperLimit': '10.71'}, {'value': '4.9', 'groupId': 'OG004', 'lowerLimit': '1.63', 'upperLimit': '13.71'}, {'value': '30.0', 'groupId': 'OG005', 'lowerLimit': '19.66', 'upperLimit': '42.87'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '1.18', 'upperLimit': '20.50'}, {'value': '41.9', 'groupId': 'OG001', 'lowerLimit': '32.18', 'upperLimit': '52.37'}, {'value': '19.5', 'groupId': 'OG002', 'lowerLimit': '11.36', 'upperLimit': '31.44'}, {'value': '12.8', 'groupId': 'OG003', 'lowerLimit': '6.38', 'upperLimit': '24.08'}, {'value': '7.3', 'groupId': 'OG004', 'lowerLimit': '2.96', 'upperLimit': '16.96'}, {'value': '40.0', 'groupId': 'OG005', 'lowerLimit': '28.29', 'upperLimit': '52.98'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '9.82', 'upperLimit': '39.50'}, {'value': '45.2', 'groupId': 'OG001', 'lowerLimit': '35.19', 'upperLimit': '55.54'}, {'value': '29.3', 'groupId': 'OG002', 'lowerLimit': '19.16', 'upperLimit': '41.94'}, {'value': '12.8', 'groupId': 'OG003', 'lowerLimit': '6.38', 'upperLimit': '24.08'}, {'value': '17.1', 'groupId': 'OG004', 'lowerLimit': '9.53', 'upperLimit': '28.69'}, {'value': '47.5', 'groupId': 'OG005', 'lowerLimit': '35.09', 'upperLimit': '60.23'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': "Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 50% response (ACR50) 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 * Patient's Assessment of Pain (Visual Analog Scale \\[VAS\\])\n * Patient's Global Assessment of Disease Activity (PtGA)\n * Physician's Global Assessment of Disease Activity (PhGA)\n * Health Assessment Questionnaire Disability Index (HAQ-DI)\n * High-sensitivity C-reactive protein (hsCRP)", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '12.46'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '3.98', 'upperLimit': '15.66'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '0.55', 'upperLimit': '10.22'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '6.49'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '6.19'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '6.34'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '12.46'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '5.09', 'upperLimit': '17.64'}, {'value': '4.9', 'groupId': 'OG002', 'lowerLimit': '1.63', 'upperLimit': '13.71'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '0.57', 'upperLimit': '10.71'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '6.19'}, {'value': '15.0', 'groupId': 'OG005', 'lowerLimit': '7.96', 'upperLimit': '26.47'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '12.46'}, {'value': '17.7', 'groupId': 'OG001', 'lowerLimit': '11.16', 'upperLimit': '27.02'}, {'value': '4.9', 'groupId': 'OG002', 'lowerLimit': '1.63', 'upperLimit': '13.71'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '0.57', 'upperLimit': '10.71'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '6.19'}, {'value': '25.0', 'groupId': 'OG005', 'lowerLimit': '15.57', 'upperLimit': '37.60'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '6.49', 'upperLimit': '33.62'}, {'value': '25.8', 'groupId': 'OG001', 'lowerLimit': '17.81', 'upperLimit': '35.82'}, {'value': '14.6', 'groupId': 'OG002', 'lowerLimit': '7.76', 'upperLimit': '25.89'}, {'value': '5.1', 'groupId': 'OG003', 'lowerLimit': '1.71', 'upperLimit': '14.37'}, {'value': '9.8', 'groupId': 'OG004', 'lowerLimit': '4.46', 'upperLimit': '20.04'}, {'value': '27.5', 'groupId': 'OG005', 'lowerLimit': '17.60', 'upperLimit': '40.25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': "Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 70% response (ACR70) 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 * Patient's Assessment of Pain (Visual Analog Scale \\[VAS\\])\n * Patient's Global Assessment of Disease Activity (PtGA)\n * Physician's Global Assessment of Disease Activity (PhGA)\n * Health Assessment Questionnaire Disability Index (HAQ-DI)\n * High-sensitivity C-reactive protein (hsCRP)", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Count 68 (TJC68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-2.47', 'groupId': 'OG000', 'lowerLimit': '-6.10', 'upperLimit': '1.16'}, {'value': '-8.42', 'groupId': 'OG001', 'lowerLimit': '-10.53', 'upperLimit': '-6.31'}, {'value': '-3.65', 'groupId': 'OG002', 'lowerLimit': '-6.23', 'upperLimit': '-1.07'}, {'value': '-3.86', 'groupId': 'OG003', 'lowerLimit': '-6.46', 'upperLimit': '-1.26'}, {'value': '-4.88', 'groupId': 'OG004', 'lowerLimit': '-7.43', 'upperLimit': '-2.33'}, {'value': '-8.57', 'groupId': 'OG005', 'lowerLimit': '-11.09', 'upperLimit': '-6.05'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-9.21', 'groupId': 'OG000', 'lowerLimit': '-13.08', 'upperLimit': '-5.34'}, {'value': '-11.86', 'groupId': 'OG001', 'lowerLimit': '-14.10', 'upperLimit': '-9.62'}, {'value': '-5.16', 'groupId': 'OG002', 'lowerLimit': '-7.93', 'upperLimit': '-2.39'}, {'value': '-5.39', 'groupId': 'OG003', 'lowerLimit': '-8.18', 'upperLimit': '-2.60'}, {'value': '-8.08', 'groupId': 'OG004', 'lowerLimit': '-10.77', 'upperLimit': '-5.39'}, {'value': '-12.76', 'groupId': 'OG005', 'lowerLimit': '-15.46', 'upperLimit': '-10.06'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-8.82', 'groupId': 'OG000', 'lowerLimit': '-12.85', 'upperLimit': '-4.79'}, {'value': '-15.44', 'groupId': 'OG001', 'lowerLimit': '-17.75', 'upperLimit': '-13.12'}, {'value': '-8.43', 'groupId': 'OG002', 'lowerLimit': '-11.31', 'upperLimit': '-5.55'}, {'value': '-10.83', 'groupId': 'OG003', 'lowerLimit': '-13.78', 'upperLimit': '-7.88'}, {'value': '-9.08', 'groupId': 'OG004', 'lowerLimit': '-11.88', 'upperLimit': '-6.27'}, {'value': '-14.76', 'groupId': 'OG005', 'lowerLimit': '-17.56', 'upperLimit': '-11.97'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-8.47', 'groupId': 'OG000', 'lowerLimit': '-12.81', 'upperLimit': '-4.12'}, {'value': '-16.33', 'groupId': 'OG001', 'lowerLimit': '-18.84', 'upperLimit': '-13.83'}, {'value': '-9.14', 'groupId': 'OG002', 'lowerLimit': '-12.23', 'upperLimit': '-6.05'}, {'value': '-9.33', 'groupId': 'OG003', 'lowerLimit': '-12.55', 'upperLimit': '-6.12'}, {'value': '-12.58', 'groupId': 'OG004', 'lowerLimit': '-15.64', 'upperLimit': '-9.52'}, {'value': '-17.56', 'groupId': 'OG005', 'lowerLimit': '-20.58', 'upperLimit': '-14.53'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'Sixty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 68 (worst possible score/68 joints with tenderness). Negative values indicate improvement from baseline.', 'unitOfMeasure': 'tender joint counts', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Swollen Joint Count 66 (SJC66)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-3.12', 'groupId': 'OG000', 'lowerLimit': '-5.20', 'upperLimit': '-1.05'}, {'value': '-6.06', 'groupId': 'OG001', 'lowerLimit': '-7.26', 'upperLimit': '-4.86'}, {'value': '-3.61', 'groupId': 'OG002', 'lowerLimit': '-5.08', 'upperLimit': '-2.14'}, {'value': '-3.30', 'groupId': 'OG003', 'lowerLimit': '-4.78', 'upperLimit': '-1.82'}, {'value': '-4.13', 'groupId': 'OG004', 'lowerLimit': '-5.60', 'upperLimit': '-2.67'}, {'value': '-6.02', 'groupId': 'OG005', 'lowerLimit': '-7.46', 'upperLimit': '-4.58'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.70', 'groupId': 'OG000', 'lowerLimit': '-6.92', 'upperLimit': '-2.49'}, {'value': '-7.96', 'groupId': 'OG001', 'lowerLimit': '-9.24', 'upperLimit': '-6.68'}, {'value': '-5.11', 'groupId': 'OG002', 'lowerLimit': '-6.69', 'upperLimit': '-3.53'}, {'value': '-4.67', 'groupId': 'OG003', 'lowerLimit': '-6.27', 'upperLimit': '-3.07'}, {'value': '-6.05', 'groupId': 'OG004', 'lowerLimit': '-7.60', 'upperLimit': '-4.51'}, {'value': '-8.81', 'groupId': 'OG005', 'lowerLimit': '-10.35', 'upperLimit': '-7.26'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.32', 'groupId': 'OG000', 'lowerLimit': '-6.57', 'upperLimit': '-2.06'}, {'value': '-10.28', 'groupId': 'OG001', 'lowerLimit': '-11.57', 'upperLimit': '-8.99'}, {'value': '-6.15', 'groupId': 'OG002', 'lowerLimit': '-7.77', 'upperLimit': '-4.54'}, {'value': '-8.08', 'groupId': 'OG003', 'lowerLimit': '-9.74', 'upperLimit': '-6.42'}, {'value': '-7.58', 'groupId': 'OG004', 'lowerLimit': '-9.15', 'upperLimit': '-6.00'}, {'value': '-10.11', 'groupId': 'OG005', 'lowerLimit': '-11.68', 'upperLimit': '-8.55'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-5.58', 'groupId': 'OG000', 'lowerLimit': '-8.05', 'upperLimit': '-3.11'}, {'value': '-10.86', 'groupId': 'OG001', 'lowerLimit': '-12.29', 'upperLimit': '-9.44'}, {'value': '-6.68', 'groupId': 'OG002', 'lowerLimit': '-8.44', 'upperLimit': '-4.92'}, {'value': '-7.85', 'groupId': 'OG003', 'lowerLimit': '-9.70', 'upperLimit': '-6.01'}, {'value': '-8.59', 'groupId': 'OG004', 'lowerLimit': '-10.35', 'upperLimit': '-6.83'}, {'value': '-11.14', 'groupId': 'OG005', 'lowerLimit': '-12.86', 'upperLimit': '-9.42'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'Sixty-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 66 (worst possible score/66 joints with swelling). Negative values indicate improvement from baseline.', 'unitOfMeasure': 'swollen joint counts', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Participant's Assessment of Pain (Visual Analog Scale [VAS])", 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-14.97', 'groupId': 'OG000', 'lowerLimit': '-22.80', 'upperLimit': '-7.14'}, {'value': '-24.02', 'groupId': 'OG001', 'lowerLimit': '-28.63', 'upperLimit': '-19.41'}, {'value': '-10.22', 'groupId': 'OG002', 'lowerLimit': '-15.81', 'upperLimit': '-4.63'}, {'value': '-8.78', 'groupId': 'OG003', 'lowerLimit': '-14.49', 'upperLimit': '-3.07'}, {'value': '-7.61', 'groupId': 'OG004', 'lowerLimit': '-13.12', 'upperLimit': '-2.11'}, {'value': '-15.99', 'groupId': 'OG005', 'lowerLimit': '-21.49', 'upperLimit': '-10.48'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-20.87', 'groupId': 'OG000', 'lowerLimit': '-29.60', 'upperLimit': '-12.14'}, {'value': '-28.17', 'groupId': 'OG001', 'lowerLimit': '-33.28', 'upperLimit': '-23.07'}, {'value': '-12.95', 'groupId': 'OG002', 'lowerLimit': '-19.27', 'upperLimit': '-6.63'}, {'value': '-8.41', 'groupId': 'OG003', 'lowerLimit': '-14.85', 'upperLimit': '-1.97'}, {'value': '-9.91', 'groupId': 'OG004', 'lowerLimit': '-15.93', 'upperLimit': '-3.88'}, {'value': '-25.58', 'groupId': 'OG005', 'lowerLimit': '-31.69', 'upperLimit': '-19.48'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-16.21', 'groupId': 'OG000', 'lowerLimit': '-25.97', 'upperLimit': '-6.45'}, {'value': '-31.86', 'groupId': 'OG001', 'lowerLimit': '-37.50', 'upperLimit': '-26.22'}, {'value': '-20.92', 'groupId': 'OG002', 'lowerLimit': '-27.96', 'upperLimit': '-13.88'}, {'value': '-11.12', 'groupId': 'OG003', 'lowerLimit': '-18.46', 'upperLimit': '-3.79'}, {'value': '-13.90', 'groupId': 'OG004', 'lowerLimit': '-20.64', 'upperLimit': '-7.16'}, {'value': '-30.70', 'groupId': 'OG005', 'lowerLimit': '-37.47', 'upperLimit': '-23.92'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-23.37', 'groupId': 'OG000', 'lowerLimit': '-33.74', 'upperLimit': '-13.01'}, {'value': '-32.27', 'groupId': 'OG001', 'lowerLimit': '-38.32', 'upperLimit': '-26.23'}, {'value': '-19.52', 'groupId': 'OG002', 'lowerLimit': '-26.97', 'upperLimit': '-12.06'}, {'value': '-10.46', 'groupId': 'OG003', 'lowerLimit': '-18.38', 'upperLimit': '-2.55'}, {'value': '-17.84', 'groupId': 'OG004', 'lowerLimit': '-25.13', 'upperLimit': '-10.55'}, {'value': '-38.34', 'groupId': 'OG005', 'lowerLimit': '-45.57', 'upperLimit': '-31.12'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'Participants rated their pain on a visual analogue scale (VAS) of 0 to 100 (mm), with 0 representing no pain and 100 representing the worst possible pain. Negative values indicate improvement from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Global Assessment of Disease Activity (PGA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-11.87', 'groupId': 'OG000', 'lowerLimit': '-20.12', 'upperLimit': '-3.63'}, {'value': '-23.44', 'groupId': 'OG001', 'lowerLimit': '-28.31', 'upperLimit': '-18.57'}, {'value': '-11.16', 'groupId': 'OG002', 'lowerLimit': '-17.07', 'upperLimit': '-5.25'}, {'value': '-6.47', 'groupId': 'OG003', 'lowerLimit': '-12.51', 'upperLimit': '-0.44'}, {'value': '-5.95', 'groupId': 'OG004', 'lowerLimit': '-11.76', 'upperLimit': '-0.14'}, {'value': '-14.76', 'groupId': 'OG005', 'lowerLimit': '-20.56', 'upperLimit': '-8.95'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-20.93', 'groupId': 'OG000', 'lowerLimit': '-29.91', 'upperLimit': '-11.94'}, {'value': '-25.97', 'groupId': 'OG001', 'lowerLimit': '-31.24', 'upperLimit': '-20.70'}, {'value': '-12.79', 'groupId': 'OG002', 'lowerLimit': '-19.32', 'upperLimit': '-6.26'}, {'value': '-7.15', 'groupId': 'OG003', 'lowerLimit': '-13.79', 'upperLimit': '-0.50'}, {'value': '-8.73', 'groupId': 'OG004', 'lowerLimit': '-14.94', 'upperLimit': '-2.51'}, {'value': '-23.02', 'groupId': 'OG005', 'lowerLimit': '-29.31', 'upperLimit': '-16.73'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-15.14', 'groupId': 'OG000', 'lowerLimit': '-25.37', 'upperLimit': '-4.91'}, {'value': '-28.05', 'groupId': 'OG001', 'lowerLimit': '-33.97', 'upperLimit': '-22.13'}, {'value': '-17.25', 'groupId': 'OG002', 'lowerLimit': '-24.65', 'upperLimit': '-9.84'}, {'value': '-6.27', 'groupId': 'OG003', 'lowerLimit': '-14.00', 'upperLimit': '1.45'}, {'value': '-14.25', 'groupId': 'OG004', 'lowerLimit': '-21.34', 'upperLimit': '-7.17'}, {'value': '-26.79', 'groupId': 'OG005', 'lowerLimit': '-33.90', 'upperLimit': '-19.69'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-19.55', 'groupId': 'OG000', 'lowerLimit': '-30.15', 'upperLimit': '-8.95'}, {'value': '-30.52', 'groupId': 'OG001', 'lowerLimit': '-36.72', 'upperLimit': '-24.32'}, {'value': '-19.47', 'groupId': 'OG002', 'lowerLimit': '-27.13', 'upperLimit': '-11.81'}, {'value': '-8.45', 'groupId': 'OG003', 'lowerLimit': '-16.58', 'upperLimit': '-0.33'}, {'value': '-16.40', 'groupId': 'OG004', 'lowerLimit': '-23.89', 'upperLimit': '-8.92'}, {'value': '-33.53', 'groupId': 'OG005', 'lowerLimit': '-40.94', 'upperLimit': '-26.13'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': "Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-16.31', 'groupId': 'OG000', 'lowerLimit': '-24.67', 'upperLimit': '-7.96'}, {'value': '-22.35', 'groupId': 'OG001', 'lowerLimit': '-27.10', 'upperLimit': '-17.60'}, {'value': '-19.01', 'groupId': 'OG002', 'lowerLimit': '-24.74', 'upperLimit': '-13.27'}, {'value': '-16.12', 'groupId': 'OG003', 'lowerLimit': '-21.97', 'upperLimit': '-10.26'}, {'value': '-11.64', 'groupId': 'OG004', 'lowerLimit': '-17.44', 'upperLimit': '-5.84'}, {'value': '-24.71', 'groupId': 'OG005', 'lowerLimit': '-30.37', 'upperLimit': '-19.05'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-25.20', 'groupId': 'OG000', 'lowerLimit': '-33.52', 'upperLimit': '-16.89'}, {'value': '-33.54', 'groupId': 'OG001', 'lowerLimit': '-38.26', 'upperLimit': '-28.82'}, {'value': '-25.33', 'groupId': 'OG002', 'lowerLimit': '-31.11', 'upperLimit': '-19.55'}, {'value': '-19.59', 'groupId': 'OG003', 'lowerLimit': '-25.49', 'upperLimit': '-13.69'}, {'value': '-18.31', 'groupId': 'OG004', 'lowerLimit': '-24.05', 'upperLimit': '-12.56'}, {'value': '-34.17', 'groupId': 'OG005', 'lowerLimit': '-39.86', 'upperLimit': '-28.49'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-24.47', 'groupId': 'OG000', 'lowerLimit': '-32.71', 'upperLimit': '-16.22'}, {'value': '-40.00', 'groupId': 'OG001', 'lowerLimit': '-44.71', 'upperLimit': '-35.29'}, {'value': '-30.06', 'groupId': 'OG002', 'lowerLimit': '-35.91', 'upperLimit': '-24.22'}, {'value': '-33.93', 'groupId': 'OG003', 'lowerLimit': '-39.99', 'upperLimit': '-27.87'}, {'value': '-25.21', 'groupId': 'OG004', 'lowerLimit': '-31.03', 'upperLimit': '-19.40'}, {'value': '-41.02', 'groupId': 'OG005', 'lowerLimit': '-46.69', 'upperLimit': '-35.36'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-23.19', 'groupId': 'OG000', 'lowerLimit': '-31.69', 'upperLimit': '-14.69'}, {'value': '-46.98', 'groupId': 'OG001', 'lowerLimit': '-52.00', 'upperLimit': '-41.96'}, {'value': '-30.15', 'groupId': 'OG002', 'lowerLimit': '-36.28', 'upperLimit': '-24.03'}, {'value': '-31.68', 'groupId': 'OG003', 'lowerLimit': '-38.19', 'upperLimit': '-25.18'}, {'value': '-24.55', 'groupId': 'OG004', 'lowerLimit': '-30.75', 'upperLimit': '-18.36'}, {'value': '-50.89', 'groupId': 'OG005', 'lowerLimit': '-56.87', 'upperLimit': '-44.91'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': "The physician assessed a participant's disease activity at the time of the visit using a Physician's Global Assessment of Disease visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'groupId': 'OG000', 'lowerLimit': '-0.37', 'upperLimit': '-0.06'}, {'value': '-0.34', 'groupId': 'OG001', 'lowerLimit': '-0.43', 'upperLimit': '-0.25'}, {'value': '-0.13', 'groupId': 'OG002', 'lowerLimit': '-0.24', 'upperLimit': '-0.02'}, {'value': '-0.06', 'groupId': 'OG003', 'lowerLimit': '-0.17', 'upperLimit': '0.05'}, {'value': '-0.16', 'groupId': 'OG004', 'lowerLimit': '-0.27', 'upperLimit': '-0.05'}, {'value': '-0.22', 'groupId': 'OG005', 'lowerLimit': '-0.33', 'upperLimit': '-0.11'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'groupId': 'OG000', 'lowerLimit': '-0.53', 'upperLimit': '-0.18'}, {'value': '-0.39', 'groupId': 'OG001', 'lowerLimit': '-0.49', 'upperLimit': '-0.29'}, {'value': '-0.11', 'groupId': 'OG002', 'lowerLimit': '-0.23', 'upperLimit': '0.02'}, {'value': '-0.14', 'groupId': 'OG003', 'lowerLimit': '-0.27', 'upperLimit': '-0.02'}, {'value': '-0.21', 'groupId': 'OG004', 'lowerLimit': '-0.33', 'upperLimit': '-0.09'}, {'value': '-0.33', 'groupId': 'OG005', 'lowerLimit': '-0.45', 'upperLimit': '-0.20'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.24', 'groupId': 'OG000', 'lowerLimit': '-0.44', 'upperLimit': '-0.05'}, {'value': '-0.47', 'groupId': 'OG001', 'lowerLimit': '-0.59', 'upperLimit': '-0.36'}, {'value': '-0.29', 'groupId': 'OG002', 'lowerLimit': '-0.43', 'upperLimit': '-0.15'}, {'value': '-0.15', 'groupId': 'OG003', 'lowerLimit': '-0.30', 'upperLimit': '-0.00'}, {'value': '-0.15', 'groupId': 'OG004', 'lowerLimit': '-0.29', 'upperLimit': '-0.02'}, {'value': '-0.47', 'groupId': 'OG005', 'lowerLimit': '-0.61', 'upperLimit': '-0.33'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG000', 'lowerLimit': '-0.52', 'upperLimit': '-0.08'}, {'value': '-0.52', 'groupId': 'OG001', 'lowerLimit': '-0.65', 'upperLimit': '-0.39'}, {'value': '-0.31', 'groupId': 'OG002', 'lowerLimit': '-0.46', 'upperLimit': '-0.15'}, {'value': '-0.12', 'groupId': 'OG003', 'lowerLimit': '-0.28', 'upperLimit': '0.05'}, {'value': '-0.18', 'groupId': 'OG004', 'lowerLimit': '-0.33', 'upperLimit': '-0.03'}, {'value': '-0.54', 'groupId': 'OG005', 'lowerLimit': '-0.70', 'upperLimit': '-0.39'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', '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': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.51', 'groupId': 'OG000', 'lowerLimit': '-4.82', 'upperLimit': '3.81'}, {'value': '-9.29', 'groupId': 'OG001', 'lowerLimit': '-11.79', 'upperLimit': '-6.80'}, {'value': '2.26', 'groupId': 'OG002', 'lowerLimit': '-0.81', 'upperLimit': '5.33'}, {'value': '-0.34', 'groupId': 'OG003', 'lowerLimit': '-3.43', 'upperLimit': '2.74'}, {'value': '-0.72', 'groupId': 'OG004', 'lowerLimit': '-3.74', 'upperLimit': '2.30'}, {'value': '-12.27', 'groupId': 'OG005', 'lowerLimit': '-15.26', 'upperLimit': '-9.27'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.54', 'groupId': 'OG000', 'lowerLimit': '-3.72', 'upperLimit': '6.79'}, {'value': '-10.08', 'groupId': 'OG001', 'lowerLimit': '-13.08', 'upperLimit': '-7.08'}, {'value': '2.71', 'groupId': 'OG002', 'lowerLimit': '-1.05', 'upperLimit': '6.46'}, {'value': '-0.78', 'groupId': 'OG003', 'lowerLimit': '-4.58', 'upperLimit': '3.02'}, {'value': '0.72', 'groupId': 'OG004', 'lowerLimit': '-2.91', 'upperLimit': '4.35'}, {'value': '-12.59', 'groupId': 'OG005', 'lowerLimit': '-16.27', 'upperLimit': '-8.92'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.23', 'groupId': 'OG000', 'lowerLimit': '-1.56', 'upperLimit': '8.03'}, {'value': '-9.97', 'groupId': 'OG001', 'lowerLimit': '-12.70', 'upperLimit': '-7.24'}, {'value': '-1.39', 'groupId': 'OG002', 'lowerLimit': '-4.83', 'upperLimit': '2.05'}, {'value': '-2.58', 'groupId': 'OG003', 'lowerLimit': '-6.15', 'upperLimit': '1.00'}, {'value': '-2.93', 'groupId': 'OG004', 'lowerLimit': '-6.26', 'upperLimit': '0.39'}, {'value': '-13.13', 'groupId': 'OG005', 'lowerLimit': '-16.46', 'upperLimit': '-9.81'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.45', 'groupId': 'OG000', 'lowerLimit': '-5.10', 'upperLimit': '8.00'}, {'value': '-10.95', 'groupId': 'OG001', 'lowerLimit': '-14.73', 'upperLimit': '-7.18'}, {'value': '-4.58', 'groupId': 'OG002', 'lowerLimit': '-9.26', 'upperLimit': '0.09'}, {'value': '-5.78', 'groupId': 'OG003', 'lowerLimit': '-10.77', 'upperLimit': '-0.78'}, {'value': '-0.81', 'groupId': 'OG004', 'lowerLimit': '-5.58', 'upperLimit': '3.97'}, {'value': '-7.44', 'groupId': 'OG005', 'lowerLimit': '-12.03', 'upperLimit': '-2.86'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'C-reactive protein is a blood test marker for inflammation in the body, and levels rise in response to inflammation. A negative change from baseline in indicates improvement.', 'unitOfMeasure': 'mg/L', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.46', 'groupId': 'OG000', 'lowerLimit': '-0.83', 'upperLimit': '-0.10'}, {'value': '-1.53', 'groupId': 'OG001', 'lowerLimit': '-1.75', 'upperLimit': '-1.31'}, {'value': '-0.63', 'groupId': 'OG002', 'lowerLimit': '-0.89', 'upperLimit': '-0.36'}, {'value': '-0.44', 'groupId': 'OG003', 'lowerLimit': '-0.71', 'upperLimit': '-0.18'}, {'value': '-0.56', 'groupId': 'OG004', 'lowerLimit': '-0.82', 'upperLimit': '-0.30'}, {'value': '-1.43', 'groupId': 'OG005', 'lowerLimit': '-1.69', 'upperLimit': '-1.17'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.90', 'groupId': 'OG000', 'lowerLimit': '-1.33', 'upperLimit': '-0.47'}, {'value': '-1.96', 'groupId': 'OG001', 'lowerLimit': '-2.21', 'upperLimit': '-1.71'}, {'value': '-0.87', 'groupId': 'OG002', 'lowerLimit': '-1.18', 'upperLimit': '-0.56'}, {'value': '-0.68', 'groupId': 'OG003', 'lowerLimit': '-1.00', 'upperLimit': '-0.36'}, {'value': '-0.82', 'groupId': 'OG004', 'lowerLimit': '-1.11', 'upperLimit': '-0.52'}, {'value': '-1.98', 'groupId': 'OG005', 'lowerLimit': '-2.28', 'upperLimit': '-1.67'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.78', 'groupId': 'OG000', 'lowerLimit': '-1.27', 'upperLimit': '-0.29'}, {'value': '-2.40', 'groupId': 'OG001', 'lowerLimit': '-2.68', 'upperLimit': '-2.11'}, {'value': '-1.21', 'groupId': 'OG002', 'lowerLimit': '-1.56', 'upperLimit': '-0.86'}, {'value': '-1.24', 'groupId': 'OG003', 'lowerLimit': '-1.61', 'upperLimit': '-0.87'}, {'value': '-1.11', 'groupId': 'OG004', 'lowerLimit': '-1.45', 'upperLimit': '-0.77'}, {'value': '-2.34', 'groupId': 'OG005', 'lowerLimit': '-2.68', 'upperLimit': '-2.00'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.12', 'groupId': 'OG000', 'lowerLimit': '-1.64', 'upperLimit': '-0.60'}, {'value': '-2.56', 'groupId': 'OG001', 'lowerLimit': '-2.86', 'upperLimit': '-2.26'}, {'value': '-1.52', 'groupId': 'OG002', 'lowerLimit': '-1.89', 'upperLimit': '-1.15'}, {'value': '-1.32', 'groupId': 'OG003', 'lowerLimit': '-1.71', 'upperLimit': '-0.93'}, {'value': '-1.33', 'groupId': 'OG004', 'lowerLimit': '-1.70', 'upperLimit': '-0.97'}, {'value': '-2.87', 'groupId': 'OG005', 'lowerLimit': '-3.23', 'upperLimit': '-2.51'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', '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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28- ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.46', 'groupId': 'OG000', 'lowerLimit': '-0.82', 'upperLimit': '-0.09'}, {'value': '-1.48', 'groupId': 'OG001', 'lowerLimit': '-1.69', 'upperLimit': '-1.26'}, {'value': '-0.52', 'groupId': 'OG002', 'lowerLimit': '-0.79', 'upperLimit': '-0.26'}, {'value': '-0.46', 'groupId': 'OG003', 'lowerLimit': '-0.74', 'upperLimit': '-0.19'}, {'value': '-0.57', 'groupId': 'OG004', 'lowerLimit': '-0.83', 'upperLimit': '-0.32'}, {'value': '-1.32', 'groupId': 'OG005', 'lowerLimit': '-1.58', 'upperLimit': '-1.06'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.86', 'groupId': 'OG000', 'lowerLimit': '-1.30', 'upperLimit': '-0.43'}, {'value': '-1.93', 'groupId': 'OG001', 'lowerLimit': '-2.19', 'upperLimit': '-1.68'}, {'value': '-0.79', 'groupId': 'OG002', 'lowerLimit': '-1.11', 'upperLimit': '-0.48'}, {'value': '-0.59', 'groupId': 'OG003', 'lowerLimit': '-0.91', 'upperLimit': '-0.26'}, {'value': '-0.92', 'groupId': 'OG004', 'lowerLimit': '-1.23', 'upperLimit': '-0.62'}, {'value': '-1.90', 'groupId': 'OG005', 'lowerLimit': '-2.20', 'upperLimit': '-1.59'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.80', 'groupId': 'OG000', 'lowerLimit': '-1.29', 'upperLimit': '-0.31'}, {'value': '-2.41', 'groupId': 'OG001', 'lowerLimit': '-2.69', 'upperLimit': '-2.12'}, {'value': '-1.07', 'groupId': 'OG002', 'lowerLimit': '-1.42', 'upperLimit': '-0.71'}, {'value': '-1.15', 'groupId': 'OG003', 'lowerLimit': '-1.52', 'upperLimit': '-0.78'}, {'value': '-1.20', 'groupId': 'OG004', 'lowerLimit': '-1.54', 'upperLimit': '-0.86'}, {'value': '-2.31', 'groupId': 'OG005', 'lowerLimit': '-2.65', 'upperLimit': '-1.97'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.18', 'groupId': 'OG000', 'lowerLimit': '-1.71', 'upperLimit': '-0.64'}, {'value': '-2.53', 'groupId': 'OG001', 'lowerLimit': '-2.84', 'upperLimit': '-2.22'}, {'value': '-1.41', 'groupId': 'OG002', 'lowerLimit': '-1.80', 'upperLimit': '-1.03'}, {'value': '-1.24', 'groupId': 'OG003', 'lowerLimit': '-1.65', 'upperLimit': '-0.83'}, {'value': '-1.44', 'groupId': 'OG004', 'lowerLimit': '-1.82', 'upperLimit': '-1.06'}, {'value': '-2.88', 'groupId': 'OG005', 'lowerLimit': '-3.25', 'upperLimit': '-2.50'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': "The DAS28-ESR is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale \\[VAS\\] from 0 to 100 mm) are included in the DAS28 -ESR score. Scores on the DAS28-ESR range from 0 to 10; higher scores indicate more disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Morning Stiffness Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.76', 'groupId': 'OG000', 'lowerLimit': '-2.54', 'upperLimit': '-0.98'}, {'value': '-2.02', 'groupId': 'OG001', 'lowerLimit': '-2.48', 'upperLimit': '-1.56'}, {'value': '-0.91', 'groupId': 'OG002', 'lowerLimit': '-1.47', 'upperLimit': '-0.35'}, {'value': '-0.68', 'groupId': 'OG003', 'lowerLimit': '-1.26', 'upperLimit': '-0.11'}, {'value': '-0.59', 'groupId': 'OG004', 'lowerLimit': '-1.15', 'upperLimit': '-0.04'}, {'value': '-1.84', 'groupId': 'OG005', 'lowerLimit': '-2.40', 'upperLimit': '-1.29'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.76', 'groupId': 'OG000', 'lowerLimit': '-2.63', 'upperLimit': '-0.90'}, {'value': '-2.71', 'groupId': 'OG001', 'lowerLimit': '-3.22', 'upperLimit': '-2.21'}, {'value': '-0.82', 'groupId': 'OG002', 'lowerLimit': '-1.45', 'upperLimit': '-0.20'}, {'value': '-0.83', 'groupId': 'OG003', 'lowerLimit': '-1.47', 'upperLimit': '-0.19'}, {'value': '-1.08', 'groupId': 'OG004', 'lowerLimit': '-1.67', 'upperLimit': '-0.48'}, {'value': '-2.51', 'groupId': 'OG005', 'lowerLimit': '-3.13', 'upperLimit': '-1.90'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.67', 'groupId': 'OG000', 'lowerLimit': '-2.56', 'upperLimit': '-0.77'}, {'value': '-3.07', 'groupId': 'OG001', 'lowerLimit': '-3.59', 'upperLimit': '-2.55'}, {'value': '-1.30', 'groupId': 'OG002', 'lowerLimit': '-1.94', 'upperLimit': '-0.65'}, {'value': '-0.97', 'groupId': 'OG003', 'lowerLimit': '-1.64', 'upperLimit': '-0.30'}, {'value': '-1.50', 'groupId': 'OG004', 'lowerLimit': '-2.11', 'upperLimit': '-0.88'}, {'value': '-3.07', 'groupId': 'OG005', 'lowerLimit': '-3.70', 'upperLimit': '-2.44'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.61', 'groupId': 'OG000', 'lowerLimit': '-2.60', 'upperLimit': '-0.63'}, {'value': '-3.23', 'groupId': 'OG001', 'lowerLimit': '-3.81', 'upperLimit': '-2.65'}, {'value': '-1.27', 'groupId': 'OG002', 'lowerLimit': '-1.99', 'upperLimit': '-0.56'}, {'value': '-1.30', 'groupId': 'OG003', 'lowerLimit': '-2.06', 'upperLimit': '-0.55'}, {'value': '-1.66', 'groupId': 'OG004', 'lowerLimit': '-2.36', 'upperLimit': '-0.97'}, {'value': '-3.36', 'groupId': 'OG005', 'lowerLimit': '-4.06', 'upperLimit': '-2.67'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe". Negative values indicate improvement from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, had non-missing baseline values, and at least one post-baseline value. Baseline is defined as the last non-missing value prior to the first dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000', 'lowerLimit': '34.67', 'upperLimit': '69.93'}, {'value': '51.6', 'groupId': 'OG001', 'lowerLimit': '41.33', 'upperLimit': '61.76'}, {'value': '36.6', 'groupId': 'OG002', 'lowerLimit': '25.40', 'upperLimit': '49.43'}, {'value': '30.8', 'groupId': 'OG003', 'lowerLimit': '20.20', 'upperLimit': '43.84'}, {'value': '36.6', 'groupId': 'OG004', 'lowerLimit': '25.40', 'upperLimit': '49.43'}, {'value': '52.5', 'groupId': 'OG005', 'lowerLimit': '39.77', 'upperLimit': '64.91'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000', 'lowerLimit': '49.55', 'upperLimit': '82.70'}, {'value': '54.8', 'groupId': 'OG001', 'lowerLimit': '44.46', 'upperLimit': '64.81'}, {'value': '34.1', 'groupId': 'OG002', 'lowerLimit': '23.29', 'upperLimit': '46.97'}, {'value': '41.0', 'groupId': 'OG003', 'lowerLimit': '29.07', 'upperLimit': '54.15'}, {'value': '53.7', 'groupId': 'OG004', 'lowerLimit': '41.02', 'upperLimit': '65.84'}, {'value': '45.0', 'groupId': 'OG005', 'lowerLimit': '32.79', 'upperLimit': '57.84'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000', 'lowerLimit': '34.67', 'upperLimit': '69.93'}, {'value': '58.1', 'groupId': 'OG001', 'lowerLimit': '47.63', 'upperLimit': '67.82'}, {'value': '51.2', 'groupId': 'OG002', 'lowerLimit': '38.71', 'upperLimit': '63.58'}, {'value': '51.3', 'groupId': 'OG003', 'lowerLimit': '38.47', 'upperLimit': '63.93'}, {'value': '36.6', 'groupId': 'OG004', 'lowerLimit': '25.40', 'upperLimit': '49.43'}, {'value': '65.0', 'groupId': 'OG005', 'lowerLimit': '52.01', 'upperLimit': '76.09'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000', 'lowerLimit': '30.07', 'upperLimit': '65.33'}, {'value': '58.1', 'groupId': 'OG001', 'lowerLimit': '47.63', 'upperLimit': '67.82'}, {'value': '53.7', 'groupId': 'OG002', 'lowerLimit': '41.02', 'upperLimit': '65.84'}, {'value': '43.6', 'groupId': 'OG003', 'lowerLimit': '31.37', 'upperLimit': '56.64'}, {'value': '43.9', 'groupId': 'OG004', 'lowerLimit': '31.93', 'upperLimit': '56.63'}, {'value': '55.0', 'groupId': 'OG005', 'lowerLimit': '42.16', 'upperLimit': '67.21'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', '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. The minimal clinically important difference (MCID) in HAQ-DI is defined as change from Baseline ≤ -0.22 for rheumatoid arthritis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (EULAR) Boolean Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'OG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'OG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '12.46'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '6.91'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '6.19'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '6.49'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '6.19'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '6.34'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '12.46'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '2.93', 'upperLimit': '13.62'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '0.55', 'upperLimit': '10.22'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '6.49'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '6.19'}, {'value': '2.5', 'groupId': 'OG005', 'lowerLimit': '0.56', 'upperLimit': '10.46'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '12.46'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '2.93', 'upperLimit': '13.62'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '0.55', 'upperLimit': '10.22'}, {'value': '5.1', 'groupId': 'OG003', 'lowerLimit': '1.71', 'upperLimit': '14.37'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '6.19'}, {'value': '12.5', 'groupId': 'OG005', 'lowerLimit': '6.22', 'upperLimit': '23.53'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '12.46'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '6.24', 'upperLimit': '19.58'}, {'value': '9.8', 'groupId': 'OG002', 'lowerLimit': '4.46', 'upperLimit': '20.04'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '0.57', 'upperLimit': '10.71'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '0.55', 'upperLimit': '10.22'}, {'value': '10.0', 'groupId': 'OG005', 'lowerLimit': '4.57', 'upperLimit': '20.50'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'The EULAR Boolean-based definition of remission is as follows: at any time point, a participant must satisfy all of the following: tender joint count ≤1, swollen joint count ≤1, C-reactive protein ≤1 mg/dl and Patient Global Assessment (PGA) ≤1 (on a 0-10 scale).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug, nonresponder imputation was used for missing data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'FG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'FG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'FG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'FG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'FG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '35'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '242', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'ELS Placebo/UPA Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'BG001', 'title': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks'}, {'id': 'BG002', 'title': 'ELS 60 mg/UPA Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'BG003', 'title': 'ELS 20 mg/UPA Placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'BG004', 'title': 'ELS 5 mg/UPA Placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks'}, {'id': 'BG005', 'title': 'UPA 15 mg/ELS Placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '9.12', 'groupId': 'BG000'}, {'value': '56.2', 'spread': '12.82', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '11.11', 'groupId': 'BG002'}, {'value': '59.7', 'spread': '10.95', 'groupId': 'BG003'}, {'value': '58.1', 'spread': '11.01', 'groupId': 'BG004'}, {'value': '57.7', 'spread': '10.60', 'groupId': 'BG005'}, {'value': '58.0', 'spread': '11.27', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '204', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '220', 'groupId': 'BG006'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of randomized study drug'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-15', 'size': 5990370, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-04T12:51', 'hasProtocol': True}, {'date': '2020-01-23', 'size': 1065092, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-04T12:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2018-09-21', 'resultsFirstSubmitDate': '2021-03-04', 'studyFirstSubmitQcDate': '2018-09-21', 'lastUpdatePostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-06', 'studyFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12', 'timeFrame': 'Baseline, Week 12', '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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Clinical Disease Activity Index (CDAI)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from baseline indicates improvement in disease activity.'}, {'measure': 'Change From Baseline in Simplified Disease Activity Index (SDAI)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm), global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (CRP; mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86.with higher scores indicating higher disease activity. A negative change from baseline indicates improvement in disease activity.'}, {'measure': 'Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12', 'timeFrame': 'At Week 12', '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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6."}, {'measure': 'Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12', 'timeFrame': 'At Week 12', '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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2."}, {'measure': 'Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria', 'timeFrame': 'Week 2, Week 4, Week 8, and Week 12', 'description': 'The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Low Disease Activity (LDA) based on CDAI is defined as achieving a CDAI of less than or equal to 10.'}, {'measure': 'Percentage of Participants Achieving Complete Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria', 'timeFrame': 'Week 2, Week 4, Week 8, and Week 12', 'description': 'The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Complete Remission (CR) based on CDAI is defined as achieving a CDAI of less than or equal to 2.8.'}, {'measure': 'Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': "Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 20% response (ACR20) 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 * Patient's Assessment of Pain (Visual Analog Scale \\[VAS\\])\n * Patient's Global Assessment of Disease Activity (PtGA)\n * Physician's Global Assessment of Disease Activity (PhGA)\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 50% (ACR50) Response', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': "Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 50% response (ACR50) 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 * Patient's Assessment of Pain (Visual Analog Scale \\[VAS\\])\n * Patient's Global Assessment of Disease Activity (PtGA)\n * Physician's Global Assessment of Disease Activity (PhGA)\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', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': "Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 70% response (ACR70) 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 * Patient's Assessment of Pain (Visual Analog Scale \\[VAS\\])\n * Patient's Global Assessment of Disease Activity (PtGA)\n * Physician's Global Assessment of Disease Activity (PhGA)\n * Health Assessment Questionnaire Disability Index (HAQ-DI)\n * High-sensitivity C-reactive protein (hsCRP)"}, {'measure': 'Change From Baseline in Tender Joint Count 68 (TJC68)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'Sixty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 68 (worst possible score/68 joints with tenderness). Negative values indicate improvement from baseline.'}, {'measure': 'Change From Baseline in Swollen Joint Count 66 (SJC66)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'Sixty-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 66 (worst possible score/66 joints with swelling). Negative values indicate improvement from baseline.'}, {'measure': "Change From Baseline in Participant's Assessment of Pain (Visual Analog Scale [VAS])", 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'Participants rated their pain on a visual analogue scale (VAS) of 0 to 100 (mm), with 0 representing no pain and 100 representing the worst possible pain. Negative values indicate improvement from baseline.'}, {'measure': "Change From Baseline in Patient's Global Assessment of Disease Activity (PGA)", 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': "Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline."}, {'measure': "Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)", 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': "The physician assessed a participant's disease activity at the time of the visit using a Physician's Global Assessment of Disease visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', '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 High-Sensitivity C-reactive Protein (hsCRP)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'C-reactive protein is a blood test marker for inflammation in the body, and levels rise in response to inflammation. A negative change from baseline in indicates improvement.'}, {'measure': 'Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', '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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity."}, {'measure': 'Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28- ESR)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': "The DAS28-ESR is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale \\[VAS\\] from 0 to 100 mm) are included in the DAS28 -ESR score. Scores on the DAS28-ESR range from 0 to 10; higher scores indicate more disease activity."}, {'measure': 'Change From Baseline in Morning Stiffness Severity', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe". Negative values indicate improvement from baseline.'}, {'measure': 'Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', '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. The minimal clinically important difference (MCID) in HAQ-DI is defined as change from Baseline ≤ -0.22 for rheumatoid arthritis.'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (EULAR) Boolean Remission', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, and Week 12', 'description': 'The EULAR Boolean-based definition of remission is as follows: at any time point, a participant must satisfy all of the following: tender joint count ≤1, swollen joint count ≤1, C-reactive protein ≤1 mg/dl and Patient Global Assessment (PGA) ≤1 (on a 0-10 scale).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elsubrutinib', 'ABBV-105', 'Upadacitinib', 'ABBV-599', 'Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis (RA)']}, 'referencesModule': {'references': [{'pmid': '38293957', 'type': 'DERIVED', 'citation': 'Fleischmann R, Friedman A, Drescher E, Singhal A, Cortes-Maisonet G, Doan T, Lu W, Wang Z, Nader A, Housley W, Cohen S, Taylor PC, Blanco R. Safety and efficacy of elsubrutinib or upadacitinib alone or in combination (ABBV-599) in patients with rheumatoid arthritis and inadequate response or intolerance to biological therapies: a multicentre, double-blind, randomised, controlled, phase 2 trial. Lancet Rheumatol. 2022 Jun;4(6):e395-e406. doi: 10.1016/S2665-9913(22)00092-3. Epub 2022 Apr 27.'}]}, 'descriptionModule': {'briefSummary': 'This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and ABBV-599 (ELS plus upadacitinib \\[UPA\\]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.', 'detailedDescription': 'This was a 12-week, randomized, double-blind, parallel-group, Phase 2, dose exploratory, multicenter study. Participants who met eligibility criteria were randomized in a 3:2:2:2:2:1 ratio to 1 of 6 treatment groups: ABBV-599 \\[UPA 15 mg/ELS 60 mg\\]); ELS 60 mg/UPA placebo; ELS 20 mg/UPA placebo; ELS 5 mg/UPA placebo; UPA 15 mg/ELS placebo; and ELS placebo/UPA placebo. The study included a 35-day maximum screening period and a 12-week treatment period with 30-day follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months based on the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA\n* Participant meets the following minimum disease activity criteria:\n\n * ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits\n * High-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L (central lab) at Screening Visit\n* Participants must have been treated for ≥ 3 months with ≥ 1 biologic disease-modifying anti-rheumatic drug (bDMARD) therapy but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration\n* Participants must have been receiving conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug\n* Participants must have discontinued all bDMARDs prior to the first dose of study drug\n\nExclusion Criteria:\n\n\\- Participant has prior exposure to any Janus Kinase (JAK) inhibitor for greater than 2 weeks (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib). A washout period of ≥ 30 days is required for any JAK inhibitor prior to the first dose of study drug.'}, 'identificationModule': {'nctId': 'NCT03682705', 'briefTitle': 'A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Rheumatoid Arthritis: A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599 Combination) With a Background of Conventional Synthetic DMARDs in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs', 'orgStudyIdInfo': {'id': 'M16-063'}, 'secondaryIdInfos': [{'id': '2018-000666-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'ELS placebo/UPA placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks', 'interventionNames': ['Drug: Placebo for elsubrutinib', 'Drug: Placebo for upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'UPA 15 mg/ELS 60 mg', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks', 'interventionNames': ['Drug: Elsubrutinib', 'Drug: Upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'ELS 60 mg/UPA placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks', 'interventionNames': ['Drug: Elsubrutinib', 'Drug: Placebo for upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'ELS 20 mg/UPA placebo', 'description': '20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks', 'interventionNames': ['Drug: Elsubrutinib', 'Drug: Placebo for upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'ELS 5 mg/UPA placebo', 'description': '5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks', 'interventionNames': ['Drug: Elsubrutinib', 'Drug: Placebo for upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'UPA 15 mg/ELS placebo', 'description': '15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks', 'interventionNames': ['Drug: Upadacitinib', 'Drug: Placebo for elsubrutinib']}], 'interventions': [{'name': 'Elsubrutinib', 'type': 'DRUG', 'otherNames': ['ABBV-105'], 'description': 'Elsubrutinib capsule will be administered orally.', 'armGroupLabels': ['ELS 20 mg/UPA placebo', 'ELS 5 mg/UPA placebo', 'ELS 60 mg/UPA placebo', 'UPA 15 mg/ELS 60 mg']}, {'name': 'Upadacitinib', 'type': 'DRUG', 'otherNames': ['ABT-494'], 'description': 'Upadacitinib tablet will be administered orally.', 'armGroupLabels': ['UPA 15 mg/ELS 60 mg', 'UPA 15 mg/ELS placebo']}, {'name': 'Placebo for elsubrutinib', 'type': 'DRUG', 'description': 'Placebo capsule for elsubrutinib will be administered orally.', 'armGroupLabels': ['ELS placebo/UPA placebo', 'UPA 15 mg/ELS placebo']}, {'name': 'Placebo for upadacitinib', 'type': 'DRUG', 'description': 'Placebo tablet for upadacitinib will be administered orally.', 'armGroupLabels': ['ELS 20 mg/UPA placebo', 'ELS 5 mg/UPA placebo', 'ELS 60 mg/UPA placebo', 'ELS placebo/UPA placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Rheum Assoc of North Alabama /ID# 167382', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'AZ Arthritis & Rheum Research /ID# 167446', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'SunValley Arthritis Center, Lt /ID# 213073', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'AZ Arthritis and Rheum Researc /ID# 167448', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Heritage Healthcare /ID# 167379', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Purushotham, Akther & Roshan K /ID# 168121', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Valerius Medical Group /ID# 168123', 'geoPoint': {'lat': 33.80307, 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'country': 'Spain', 'facility': 'Hospital Universitario y Politecnico La Fe /ID# 202139', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 201976', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'OX3 7LF', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'University of Oxford /ID# 201974', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'WA5 1LZ', 'city': 'Warrington', 'country': 'United Kingdom', 'facility': 'Warrington and Halton Teaching Hosp NHS Foundation Trust /ID# 206002', 'geoPoint': {'lat': 53.39254, 'lon': -2.58024}}], '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'], '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'}}}}