Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT03978520
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2019-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'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': 'All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.', 'description': 'TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.', 'eventGroups': [{'id': 'EG000', 'title': 'Elsubrutinib Placebo/Upadacitinib Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 39, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 38, 'seriousNumAtRisk': 68, 'deathsNumAffected': 2, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Elsubrutinib Placebo/Upadacitinib 30 mg', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 35, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 28, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'Elsubrutinib 60 mg/Upadacitinib Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 36, 'seriousNumAtRisk': 67, 'deathsNumAffected': 2, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'HERPES ZOSTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ORAL HERPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ACNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PERICARDIAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'STRESS CARDIOMYOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'DYSPHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'OESOPHAGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ACCIDENTAL DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ABSCESS LIMB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 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62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'HYPERTENSIVE URGENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'VENOUS THROMBOSIS LIMB', 'notes': "Clotted peripheral IV catheter in participant's arm", 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Elsubrutinib Placebo/Upadacitinib Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks'}, {'id': 'OG001', 'title': 'ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}, {'id': 'OG002', 'title': 'Elsubrutinib Placebo/Upadacitinib 30 mg', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '48.3'}, {'value': '48.5', 'groupId': 'OG001', 'lowerLimit': '36.7', 'upperLimit': '60.4'}, {'value': '54.8', 'groupId': 'OG002', 'lowerLimit': '42.5', 'upperLimit': '67.2'}]}]}], 'analyses': [{'pValue': '=0.081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.8', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '27.1', 'groupDescription': 'ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo\n\nThe difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \\> 10 mg), screening SLEDAI-2K (\\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \\[MTX\\], mycophenolate) (yes or no).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.028', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.9', 'ciLowerLimit': '1.8', 'ciUpperLimit': '31.9', 'groupDescription': 'Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo\n\nThe difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \\> 10 mg), screening SLEDAI-2K (\\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \\[MTX\\], mycophenolate) (yes or no).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.566', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.7', 'ciLowerLimit': '-20.8', 'ciUpperLimit': '11.4', 'groupDescription': 'ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg\n\nThe difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \\> 10 mg), screening SLEDAI-2K (\\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \\[MTX\\], mycophenolate) (yes or no).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': "SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:\n\n* ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score\n* No worsening of the overall condition (\\< 0.3 point increase in Physician's Global Assessment \\[PhGA\\])\n* No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C). When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Elsubrutinib Placebo/Upadacitinib Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks'}, {'id': 'OG001', 'title': 'ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}, {'id': 'OG002', 'title': 'Elsubrutinib Placebo/Upadacitinib 30 mg', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': '49.7'}, {'value': '54.4', 'groupId': 'OG001', 'lowerLimit': '42.6', 'upperLimit': '66.2'}, {'value': '56.5', 'groupId': 'OG002', 'lowerLimit': '44.1', 'upperLimit': '68.8'}]}]}], 'analyses': [{'pValue': '=0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.3', 'ciLowerLimit': '3.9', 'ciUpperLimit': '32.6', 'groupDescription': 'ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo\n\nThe difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \\> 10 mg), screening SLEDAI-2K (\\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \\[MTX\\], mycophenolate) (yes or no).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.018', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.1', 'ciLowerLimit': '3.0', 'ciUpperLimit': '33.2', 'groupDescription': 'Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo\n\nThe difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \\> 10 mg), screening SLEDAI-2K (\\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \\[MTX\\], mycophenolate) (yes or no).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.882', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-17.6', 'ciUpperLimit': '15.2', 'groupDescription': 'ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg\n\nThe difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \\> 10 mg), screening SLEDAI-2K (\\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \\[MTX\\], mycophenolate) (yes or no).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': "SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:\n\n* ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score\n* No worsening of the overall condition (\\< 0.3 point increase in Physician's Global Assessment \\[PhGA\\])\n* No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C). When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Elsubrutinib Placebo/Upadacitinib Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks'}, {'id': 'OG001', 'title': 'ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}, {'id': 'OG002', 'title': 'Elsubrutinib Placebo/Upadacitinib 30 mg', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000', 'lowerLimit': '31.5', 'upperLimit': '53.9'}, {'value': '54.4', 'groupId': 'OG001', 'lowerLimit': '42.6', 'upperLimit': '66.2'}, {'value': '58.1', 'groupId': 'OG002', 'lowerLimit': '45.8', 'upperLimit': '70.3'}]}]}], 'analyses': [{'pValue': '=0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.7', 'ciLowerLimit': '0.0', 'ciUpperLimit': '29.4', 'groupDescription': 'ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo\n\nThe difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \\> 10 mg), screening SLEDAI-2K (\\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \\[MTX\\], mycophenolate) (yes or no).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.091', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.9', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '30.1', 'groupDescription': 'Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo\n\nThe difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \\> 10 mg), screening SLEDAI-2K (\\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \\[MTX\\], mycophenolate) (yes or no).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.447', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.3', 'ciLowerLimit': '-22.5', 'ciUpperLimit': '9.9', 'groupDescription': 'ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib 30 mg\n\nThe difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \\> 10 mg), screening SLEDAI-2K (\\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \\[MTX\\], mycophenolate) (yes or no).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': "BICLA is a composite responder index. Achievement of BICLA response is defined as improvement in all initial A and B BILAG scores, with no more than one new BILAG B score without worsening of the overall condition (no worsening in Physician's Global Assessment \\[PhGA\\], \\< 0.3 point increase) and no worsening of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C). When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Elsubrutinib Placebo/Upadacitinib Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks'}, {'id': 'OG001', 'title': 'ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}, {'id': 'OG002', 'title': 'Elsubrutinib Placebo/Upadacitinib 30 mg', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '21.0'}, {'value': '30.9', 'groupId': 'OG001', 'lowerLimit': '19.9', 'upperLimit': '41.9'}, {'value': '45.2', 'groupId': 'OG002', 'lowerLimit': '32.8', 'upperLimit': '57.5'}]}]}], 'analyses': [{'pValue': '=0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.7', 'ciLowerLimit': '4.5', 'ciUpperLimit': '28.9', 'groupDescription': 'ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo\n\nThe difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \\> 10 mg), screening SLEDAI-2K (\\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \\[MTX\\], mycophenolate) (yes or no).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.0', 'ciLowerLimit': '18.1', 'ciUpperLimit': '44.0', 'groupDescription': 'Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.068', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.7', 'ciLowerLimit': '-28.4', 'ciUpperLimit': '1.0', 'groupDescription': 'ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg\n\nThe difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \\> 10 mg), screening SLEDAI-2K (\\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \\[MTX\\], mycophenolate) (yes or no).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': "LLDAS is a state of low disease activity based on Systemic Lupus Erythematosus Disease Activity Index 2000 score (SLEDAI-2K score ≤4 excluding SLEDAI-2K activity in major organ systems), absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment (PhGA ≤1), and concomitant medication usage (steroid dose ≤7.5 mg QD and toleration of immunosuppressive drugs at standard maintenance doses).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C). When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily Prednisone Dose at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Elsubrutinib Placebo/Upadacitinib Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks'}, {'id': 'OG001', 'title': 'ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}, {'id': 'OG002', 'title': 'Elsubrutinib Placebo/Upadacitinib 30 mg', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.65', 'groupId': 'OG000', 'lowerLimit': '-1.57', 'upperLimit': '0.28'}, {'value': '-0.45', 'groupId': 'OG001', 'lowerLimit': '-1.38', 'upperLimit': '0.48'}, {'value': '-0.62', 'groupId': 'OG002', 'lowerLimit': '-1.60', 'upperLimit': '0.36'}]}]}], 'analyses': [{'pValue': '=0.710', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '1.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.527', 'groupDescription': 'ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo\n\nThe Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \\> 10 mg prednisone-equivalent (≤ 10 mg or \\>10 mg), screening SLEDAI-2K (\\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline.', 'statisticalMethod': 'Mixed-effect model repeat measurement', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.963', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '1.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.545', 'groupDescription': 'Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo\n\nThe Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \\> 10 mg prednisone-equivalent (≤ 10 mg or \\>10 mg), screening SLEDAI-2K (\\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline.', 'statisticalMethod': 'Mixed-effect model repeat measurement', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.754', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '1.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.547', 'groupDescription': 'ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg\n\nThe Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \\> 10 mg prednisone-equivalent (≤ 10 mg or \\>10 mg), screening SLEDAI-2K (\\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline.', 'statisticalMethod': 'Mixed-effect model repeat measurement', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': "Participants' current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented.", 'unitOfMeasure': 'mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug with available data; Mixed-Effect Model Repeat Measurement was used. When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Elsubrutinib Placebo/Upadacitinib Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks'}, {'id': 'OG001', 'title': 'ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}, {'id': 'OG002', 'title': 'Elsubrutinib Placebo/Upadacitinib 30 mg', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}], 'classes': [{'title': 'Mild/Moderate', 'categories': [{'measurements': [{'value': '2.45', 'groupId': 'OG000', 'lowerLimit': '1.92', 'upperLimit': '2.99'}, {'value': '1.39', 'groupId': 'OG001', 'lowerLimit': '0.97', 'upperLimit': '1.81'}, {'value': '1.76', 'groupId': 'OG002', 'lowerLimit': '1.28', 'upperLimit': '2.25'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.56'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.44'}, {'value': '0.10', 'groupId': 'OG002', 'lowerLimit': '-0.01', 'upperLimit': '0.22'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '2.81', 'groupId': 'OG000', 'lowerLimit': '2.24', 'upperLimit': '3.38'}, {'value': '1.65', 'groupId': 'OG001', 'lowerLimit': '1.20', 'upperLimit': '2.10'}, {'value': '1.87', 'groupId': 'OG002', 'lowerLimit': '1.37', 'upperLimit': '2.36'}]}]}], 'analyses': [{'pValue': '=0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.06', 'ciLowerLimit': '-1.74', 'ciUpperLimit': '-0.39', 'groupDescription': 'Mild/Moderate\n\nABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib placebo\n\nA negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.', 'statisticalMethod': 'Binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.059', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '0.03', 'groupDescription': 'Mild/Moderate\n\nElsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo\n\nA negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.', 'statisticalMethod': 'Binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.252', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '0.27', 'groupDescription': 'Mild/Moderate\n\nABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg\n\nA negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.', 'statisticalMethod': 'Binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.467', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.17', 'groupDescription': 'Severe\n\nABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo\n\nA negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.', 'statisticalMethod': 'Binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.033', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '-0.02', 'groupDescription': 'Severe\n\nElsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo\n\nA negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.', 'statisticalMethod': 'Binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.156', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.37', 'groupDescription': 'Severe\n\nABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg\n\nA negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.', 'statisticalMethod': 'Binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-1.89', 'ciUpperLimit': '-0.44', 'groupDescription': 'Overall\n\nABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo\n\nA negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.', 'statisticalMethod': 'Binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.95', 'ciLowerLimit': '-1.70', 'ciUpperLimit': '-0.19', 'groupDescription': 'Overall\n\nElsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo\n\nA negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.', 'statisticalMethod': 'Binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.526', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '0.46', 'groupDescription': 'Overall\n\nABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg\n\nA negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates.', 'statisticalMethod': 'Binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to Week 24', 'description': "The SELENA SLEDAI flare index defines mild/moderate or severe SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.", 'unitOfMeasure': 'Events per patient-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug with available data; data as observed. When 50% of planned participants had completed Week 24 or withdrawn from the study, the ABBV-599 Low Dose and elsubrutinib 60 mg treatment groups were terminated as these groups did not meet projected efficacy. Per protocol, terminated groups were removed from the efficacy analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Elsubrutinib Placebo/Upadacitinib Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks'}, {'id': 'FG001', 'title': 'ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}, {'id': 'FG002', 'title': 'Elsubrutinib Placebo/Upadacitinib 30 mg', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}, {'id': 'FG003', 'title': 'ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks'}, {'id': 'FG004', 'title': 'Elsubrutinib 60 mg/Upadacitinib Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '69'}, {'groupId': 'FG004', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '45'}, {'groupId': 'FG004', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'COVID-19 infection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Sponsor decision based on interim analysis data review', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '33'}, {'groupId': 'FG004', 'numSubjects': '24'}]}]}], 'preAssignmentDetails': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}, {'value': '341', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Elsubrutinib Placebo/Upadacitinib Placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks'}, {'id': 'BG001', 'title': 'ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}, {'id': 'BG002', 'title': 'Elsubrutinib Placebo/Upadacitinib 30 mg', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks'}, {'id': 'BG003', 'title': 'ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks'}, {'id': 'BG004', 'title': 'Elsubrutinib 60 mg/Upadacitinib Placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'spread': '12.05', 'groupId': 'BG000'}, {'value': '42.7', 'spread': '11.27', 'groupId': 'BG001'}, {'value': '42.5', 'spread': '11.89', 'groupId': 'BG002'}, {'value': '41.4', 'spread': '11.85', 'groupId': 'BG003'}, {'value': '42.0', 'spread': '11.84', 'groupId': 'BG004'}, {'value': '42.1', 'spread': '11.73', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '319', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', '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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score', 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '3.88', 'groupId': 'BG000'}, {'value': '8.9', 'spread': '2.75', 'groupId': 'BG001'}, {'value': '9.0', 'spread': '2.75', 'groupId': 'BG002'}, {'value': '8.8', 'spread': '2.86', 'groupId': 'BG003'}, {'value': '9.2', 'spread': '3.18', 'groupId': 'BG004'}, {'value': '9.0', 'spread': '3.12', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'The SLEDAI-2K is a global SLE disease activity index that focuses on high-impact disease manifestations across 9 organ systems. It includes 24 clinical and laboratory variables with manifestations weighted by the affected organ system. Scores range from 0 to 105, with higher scores indicating more severe disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Physician's Global Assessment (PhGA) score", 'classes': [{'categories': [{'measurements': [{'value': '1.75', 'spread': '0.440', 'groupId': 'BG000'}, {'value': '1.80', 'spread': '0.417', 'groupId': 'BG001'}, {'value': '1.70', 'spread': '0.438', 'groupId': 'BG002'}, {'value': '1.77', 'spread': '0.422', 'groupId': 'BG003'}, {'value': '1.77', 'spread': '0.392', 'groupId': 'BG004'}, {'value': '1.76', 'spread': '0.421', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': "Physician's assessment of patient's overall disease activity due to Systemic Lupus Erythematosus (SLE), as compared with all possible participants with SLE. The benchmarks of the visual analog scale are 0, 1, 2, and 3 on the line corresponding to no, mild, moderate, and severe SLE disease activity, respectively.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Daily dose of corticosteroid', 'classes': [{'categories': [{'measurements': [{'value': '7.937', 'spread': '7.1270', 'groupId': 'BG000'}, {'value': '6.743', 'spread': '6.3736', 'groupId': 'BG001'}, {'value': '6.242', 'spread': '6.0920', 'groupId': 'BG002'}, {'value': '6.891', 'spread': '6.1056', 'groupId': 'BG003'}, {'value': '6.291', 'spread': '6.1096', 'groupId': 'BG004'}, {'value': '6.856', 'spread': '6.3885', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/day', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-25', 'size': 5347362, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-27T10:53', 'hasProtocol': True}, {'date': '2022-07-26', 'size': 408423, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-27T10:54', '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': 341}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'dispFirstSubmitDate': '2022-12-19', 'completionDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2019-06-03', 'dispFirstSubmitQcDate': '2022-12-19', 'resultsFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2019-06-05', 'dispFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-27', 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': "SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:\n\n* ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score\n* No worsening of the overall condition (\\< 0.3 point increase in Physician's Global Assessment \\[PhGA\\])\n* No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': "SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:\n\n* ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score\n* No worsening of the overall condition (\\< 0.3 point increase in Physician's Global Assessment \\[PhGA\\])\n* No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history."}, {'measure': 'Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': "BICLA is a composite responder index. Achievement of BICLA response is defined as improvement in all initial A and B BILAG scores, with no more than one new BILAG B score without worsening of the overall condition (no worsening in Physician's Global Assessment \\[PhGA\\], \\< 0.3 point increase) and no worsening of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score."}, {'measure': 'Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': "LLDAS is a state of low disease activity based on Systemic Lupus Erythematosus Disease Activity Index 2000 score (SLEDAI-2K score ≤4 excluding SLEDAI-2K activity in major organ systems), absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment (PhGA ≤1), and concomitant medication usage (steroid dose ≤7.5 mg QD and toleration of immunosuppressive drugs at standard maintenance doses)."}, {'measure': 'Change From Baseline in Daily Prednisone Dose at Week 24', 'timeFrame': 'From Baseline to Week 24', 'description': "Participants' current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented."}, {'measure': 'Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24', 'timeFrame': 'From Baseline to Week 24', 'description': "The SELENA SLEDAI flare index defines mild/moderate or severe SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus (SLE)', 'ABBV-105', 'Upadacitinib', 'ABBV-599', 'Elsubrutinib'], 'conditions': ['Systemic Lupus Erythematosus (SLE)']}, 'referencesModule': {'references': [{'pmid': '33687069', 'type': 'DERIVED', 'citation': 'Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.'}], 'seeAlsoLinks': [{'url': 'https://www.rxabbvie.com/', 'label': 'This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant has clinical diagnosis of Systemic Lupus Erythematosus (SLE) at least 24 weeks prior to Screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.\n* At Screening, must have at least one of the following:\n\n * antinuclear antibody (ANA)+ (titer ≥ 1:80)\n * anti-dsDNA+\n * anti-Smith+\n* SLEDAI-2K (SLE Disease Activity Index) ≥ 6 despite background therapy as reported and independently adjudicated (clinical score ≥ 4, excluding lupus headache and/or organic brain syndrome) at Screening:\n\n * If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints.\n * If participant has rash and Principal Investigator (PI) considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication.\n * Score must be re-confirmed at the Baseline visit.\n* Physician's Global Assessment (PhGA) ≥ 1 during screening period.\n* Must be on background treatment, stable for 30 days prior to Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (≤ 20 mg), azathioprine (≤ 150 mg), mycophenolate (\\<2 g), leflunomide (≤ 20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (≤ 20 mg).\n\n * No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials.\n\nExclusion Criteria:\n\n\\- Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization."}, 'identificationModule': {'nctId': 'NCT03978520', 'acronym': 'SLEek', 'briefTitle': 'A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'M19-130'}, 'secondaryIdInfos': [{'id': '2019-000638-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Elsubrutinib placebo/upadacitinib placebo', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks', 'interventionNames': ['Drug: Placebo for elsubrutinib', 'Drug: Placebo for upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks', 'interventionNames': ['Drug: Elsubrutinib', 'Drug: Upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Elsubrutinib placebo/upadacitinib 30 mg', 'description': 'Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks', 'interventionNames': ['Drug: Placebo for elsubrutinib', 'Drug: Upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg)', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks', 'interventionNames': ['Drug: Elsubrutinib', 'Drug: Upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Elsubrutinib 60 mg/upadacitinib placebo', 'description': '60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks', 'interventionNames': ['Drug: Elsubrutinib', 'Drug: Placebo for upadacitinib']}], 'interventions': [{'name': 'Elsubrutinib', 'type': 'DRUG', 'otherNames': ['ABBV-105'], 'description': 'Capsule; Oral', 'armGroupLabels': ['ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg)', 'ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg)', 'Elsubrutinib 60 mg/upadacitinib placebo']}, {'name': 'Placebo for elsubrutinib', 'type': 'DRUG', 'description': 'Capsule; Oral', 'armGroupLabels': ['Elsubrutinib placebo/upadacitinib 30 mg', 'Elsubrutinib placebo/upadacitinib placebo']}, {'name': 'Upadacitinib', 'type': 'DRUG', 'otherNames': ['RINVOQ'], 'description': 'Film-coated tablet; Oral', 'armGroupLabels': ['ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg)', 'ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg)', 'Elsubrutinib placebo/upadacitinib 30 mg']}, {'name': 'Placebo for upadacitinib', 'type': 'DRUG', 'description': 'Film-coated tablet; Oral', 'armGroupLabels': ['Elsubrutinib 60 mg/upadacitinib placebo', 'Elsubrutinib placebo/upadacitinib placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85210-6871', 'city': 'Mesa', 'state': 'Arizona', 'country': 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'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'BayCare Medical Group, Inc. /ID# 218818', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60523-1245', 'city': 'Oak Brook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Affinity Clinical Research /ID# 211496', 'geoPoint': {'lat': 41.83281, 'lon': -87.92895}}, {'zip': '60061', 'city': 'Vernon Hills', 'state': 'Illinois', 'country': 'United States', 'facility': 'Deerbrook Medical Associates /ID# 212251', 'geoPoint': {'lat': 42.21947, 'lon': -87.97952}}, {'zip': '47714-0805', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Qualmedica Research, LLC /ID# 214765', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics /ID# 215246', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '20902', 'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Center for Rheumatology and Bone Research /ID# 211610', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'zip': '02215-5400', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center /ID# 212321', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System /ID# 211676', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'June DO, PC /ID# 211674', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '63131-1703', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'West County Rheumatology /ID# 225051', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 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This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, 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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}