Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-01-04 @ 6:10 PM
Study NCT ID:
NCT02265705
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2014-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596027', 'term': 'baricitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Start of treatment to end of study (Up To 52 Weeks)', 'description': 'All randomized participants who received at least one dose of the study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Treatment Period Week 0-24', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 72, 'seriousNumAtRisk': 145, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': '4 Milligrams (mg) Baricitinib Treatment Period Week 0-24', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 94, 'seriousNumAtRisk': 145, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Rescue Treatment Period Week 16-52', 'description': 'All participants who are non-responders (both baricitinib and placebo arms) will receive rescue therapy at Week 16.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 38, 'seriousNumAtRisk': 77, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Placebo to Baricitinib Treatment Period Week 24 - 52', 'description': 'At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 31, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': '4 mg Baricitinib Treatment Period Week 24-52', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 41, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Placebo Follow-up Period', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '4 mg Baricitinib Follow-up Period', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 3, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 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'MedDRA 19.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 37, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 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'EG001', 'numAtRisk': 145, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 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9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, 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'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal tubular acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.'}, {'id': 'OG001', 'title': 'Baricitinib', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}, {'value': '58.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '2.5', 'ciUpperLimit': '6.9', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \\* 100.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.'}, {'id': 'OG001', 'title': 'Baricitinib', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '-0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.056', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \\[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug and had an evaluable score at Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Disease Activity Score Modified to Include the 28 Diarthroidal Joint Count (DAS28)-High Sensitivity C-Reactive Protein (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.'}, {'id': 'OG001', 'title': 'Baricitinib', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.94', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-1.89', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.02', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '-0.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.116', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56\\*square root (sqrt)(TJC28)+0.28\\*sqrt(SJC28)+0.36\\*natural log(CRP+1)+0.014\\*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP \\<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.'}, {'id': 'OG001', 'title': 'Baricitinib', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '3.3', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': "SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Median Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.'}, {'id': 'OG001', 'title': 'Baricitinib', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '67.9'}, {'value': '24.3', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '30.6'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.9', 'ciLowerLimit': '-28.0', 'ciUpperLimit': '-2.9', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 12', 'description': "Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into paper diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.", 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.'}, {'type': 'SECONDARY', 'title': 'Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.'}, {'id': 'OG001', 'title': 'Baricitinib', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in paper diaries. The average value across the 7 days preceding each visit was calculated.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.'}, {'type': 'SECONDARY', 'title': 'Mean Worst Tiredness Numeric Rating Scale (NRS) in the 7 Days Prior to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.'}, {'id': 'OG001', 'title': 'Baricitinib', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in paper diaries. The average value across the 7 days preceding each visit is calculated.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.'}, {'type': 'SECONDARY', 'title': 'Mean Worst Pain NRS in the 7 Days Prior to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.'}, {'id': 'OG001', 'title': 'Baricitinib', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily paper diaries. The average value across the 7 days preceding each visit was calculated.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable score at Week 12.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Treatment Period Week 0-24', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.'}, {'id': 'FG001', 'title': '4 Milligrams (mg) Baricitinib Treatment Period Week 0-24', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.'}, {'id': 'FG002', 'title': 'Rescue Treatment Period Week 16-52', 'description': 'All participants who are non-responders (both baricitinib and placebo arms) will receive rescue therapy at Week 16.'}, {'id': 'FG003', 'title': 'Placebo to Baricitinib Treatment Period Week 24 - 52', 'description': 'At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.'}, {'id': 'FG004', 'title': '4 mg Baricitinib Treatment Period Week 24-52', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.'}, {'id': 'FG005', 'title': 'Placebo Follow-up Period', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.'}, {'id': 'FG006', 'title': '4 mg Baricitinib Follow-up Period', 'description': '4 mg baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.'}], 'periods': [{'title': 'Treatment Period Week 0-24', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Rescued', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '"Completers" include rescued participants.', 'groupId': 'FG000', 'numSubjects': '133'}, {'comment': '"Completers" include rescued participants.', 'groupId': 'FG001', 'numSubjects': '136'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Rescue Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who were nonresponders based on tender/swollen joint count entered into rescue group.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants who were nonresponders based on tender/swollen joint count entered into rescue group.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Participants who were determined to be nonresponders based on tender/swollen joint count.', 'groupId': 'FG002', 'numSubjects': '77'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '74'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Open Label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Completed Wk 24 w/o rescue Tx, switched to or remained on active Tx, and entered Open Label Period.', 'groupId': 'FG003', 'numSubjects': '74'}, {'comment': 'Completed Wk 24 w/o rescue Tx, switched to or remained on active Tx, and entered Open Label Period.', 'groupId': 'FG004', 'numSubjects': '120'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '72'}, {'groupId': 'FG004', 'numSubjects': '115'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Participants from placebo who never rescued or switched and entered post-treatment follow-up period.', 'groupId': 'FG005', 'numSubjects': '2'}, {'comment': 'Participants who ever took baricitinib and entered the post-treatment follow-up period.', 'groupId': 'FG006', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment (Tx) beginning at Week 16.\n\nNonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count at both Weeks 14 and 16 compared to baseline.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.\n\nParticipants will continue to take background MTX therapy throughout study. Other background therapies, including NSAIDs and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.\n\nPlacebo: Administered orally'}, {'id': 'BG001', 'title': 'Baricitinib', 'description': '4 milligrams (mg) baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.\n\nParticipants will continue to take background methotrexate (MTX) therapy throughout study. Other background therapies, including non-steroidal anti-inflammatory drugs (NSAIDs) and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.\n\nBaricitinib: Administered orally'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '49.5', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '49.2', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Rheumatoid Arthritis', 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '10.7', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '9.9', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Time from symptom onset of Rheumatoid Arthritis.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tender Joint Count of 68 Evaluable Joints', 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '23.3', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '24.2', 'spread': '14.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.', 'unitOfMeasure': 'Tender Joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Swollen Joint Count of 66 Evaluable Joints', 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '14.6', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '14.7', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.', 'unitOfMeasure': 'Swollen Joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High Sensitivity C-Reactive Protein (hsCRP)', 'classes': [{'categories': [{'measurements': [{'value': '26.48', 'spread': '31.27', 'groupId': 'BG000'}, {'value': '25.59', 'spread': '23.53', 'groupId': 'BG001'}, {'value': '26.04', 'spread': '27.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.', 'unitOfMeasure': 'milligrams per liter (mg/L)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least one dose of the study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-07', 'size': 980038, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-14T01:40', 'hasProtocol': True}, {'date': '2017-01-12', 'size': 1719090, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-05-14T01:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2014-10-13', 'resultsFirstSubmitDate': '2018-05-15', 'studyFirstSubmitQcDate': '2014-10-13', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-11', 'studyFirstPostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)', 'timeFrame': 'Week 12', 'description': "ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \\* 100."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score', 'timeFrame': 'Baseline, Week 12', 'description': "The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \\[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition."}, {'measure': 'Change From Baseline to Week 12 in Disease Activity Score Modified to Include the 28 Diarthroidal Joint Count (DAS28)-High Sensitivity C-Reactive Protein (hsCRP)', 'timeFrame': 'Baseline, Week 12', 'description': "Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56\\*square root (sqrt)(TJC28)+0.28\\*sqrt(SJC28)+0.36\\*natural log(CRP+1)+0.014\\*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP \\<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition."}, {'measure': 'Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3', 'timeFrame': 'Week 12', 'description': "SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3."}, {'measure': 'Median Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12', 'timeFrame': 'Week 12', 'description': "Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into paper diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition."}, {'measure': 'Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12', 'timeFrame': 'Week 12', 'description': 'Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in paper diaries. The average value across the 7 days preceding each visit was calculated.'}, {'measure': 'Mean Worst Tiredness Numeric Rating Scale (NRS) in the 7 Days Prior to Week 12', 'timeFrame': 'Week 12', 'description': 'Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in paper diaries. The average value across the 7 days preceding each visit is calculated.'}, {'measure': 'Mean Worst Pain NRS in the 7 Days Prior to Week 12', 'timeFrame': 'Week 12', 'description': 'Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily paper diaries. The average value across the 7 days preceding each visit was calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '34706874', 'type': 'DERIVED', 'citation': 'Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.'}, {'pmid': '33959198', 'type': 'DERIVED', 'citation': 'Yang Y, Xu J, Xu J, Li X, Hu J, Li X, Zhang X, He D, Bao C, Li Z, Wang G, Zerbini CAF, Spindler AJ, Kannowski CL, Wu H, Ji F, Zhan L, Liu M, Li Z. Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib versus placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study. Ther Adv Musculoskelet Dis. 2021 Apr 20;13:1759720X211006964. doi: 10.1177/1759720X211006964. eCollection 2021.'}, {'pmid': '33237533', 'type': 'DERIVED', 'citation': 'Li ZG, Hu JK, Li XP, Yang Y, Li XF, Xu JH, Zhang X, Xu J, Bao CD, He DY, Li ZJ, Wang GC, Zuo XX, Liu Y, Xiao ZY, Chen JW, Xin XF, Li JY, Jiang LD, Liu MR, Ji F, Li CG. Rapid Onset of Efficacy of Baricitinib in Chinese Patients with Moderate to Severe Rheumatoid Arthritis: Results from Study RA-BALANCE. Adv Ther. 2021 Jan;38(1):772-781. doi: 10.1007/s12325-020-01572-y. Epub 2020 Nov 25.'}, {'pmid': '32876903', 'type': 'DERIVED', 'citation': 'Yang Y, Li XF, Zhang X, Bao CD, Hu JK, Xu JH, Li XP, Xu J, He DY, Li ZJ, Wang GC, Wu HJ, Ji F, Zhan LJ, Zerbini CAF, Li ZG. Efficacy and Safety of Baricitinib in Chinese Rheumatoid Arthritis Patients and the Subgroup Analyses: Results from Study RA-BALANCE. Rheumatol Ther. 2020 Dec;7(4):851-866. doi: 10.1007/s40744-020-00231-6. Epub 2020 Sep 2.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as baricitinib in participants with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a diagnosis of adult-onset RA as defined by the ACR/European League Against Rheumatism (EULAR) 2010 Criteria for the Classification of RA.\n* Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints.\n* Have a CRP (or hsCRP) measurement ≥ 6 mg/liter (L) based on the most recent data (if available).\n* Have had regular use of MTX for at least the 12 weeks prior to study entry at a dose that, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response. The dose of MTX must have been a stable, unchanging oral dose of 7.5 to 25 mg/week (or the equivalent injectable dose) for at least the 8 weeks prior to study entry. The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons.\n\nExclusion Criteria:\n\n* Are currently receiving corticosteroids at doses \\>10 mg of prednisone per day (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization.\n* Have started treatment with NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization.\n* Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine or combination of any 3 conventional disease modifying anti-rheumatic drugs (cDMARDs).\n* Are currently receiving or have received cDMARDs (for example, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 8 weeks prior to study entry.\n* Have received leflunomide in the 12 weeks prior to study entry (or within 4 weeks prior to study entry if the standard 11 days of cholestyramine is used to washout leflunomide).\n* Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry.\n* Have ever received any biologic DMARD (such as tumor necrosis factor (TNF), interleukin-1, interleukin-6 (IL-6), or T-cell- or B-cell-targeted therapies).\n* Have received any parenteral corticosteroid administered by intramuscular or intravenous injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.\n* Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.\n* Have a diagnosis of any systemic inflammatory condition other than RA such as, but not limited to, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout.\n* Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of \\<40 milliliters/minute/1.73 meters squared (m\\^2).\n* Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>1.5 times the upper limit of normal (ULN) or the most recent available total bilirubin 1.5 times the ULN.\n* Have a current or recent (\\<30 days prior to study entry) clinically serious viral, bacterial, fungal, or parasitic infection.\n* Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB.\n* Have evidence of active TB or have previously had evidence of active TB and did not receive appropriate and documented treatment.\n* Are pregnant or nursing at the time of study entry.\n* Are females of childbearing potential who do not agree to use 2 forms of highly effective birth control when engaging in intercourse while enrolled in the study and for at least 28 days following the last dose of orally administered investigational product.\n* Are males who do not agree to use 2 forms of highly effective birth control while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 28 days following the last dose of orally administered investigational product.\n* Have previously been randomized in this study or any other study investigating baricitinib.\n* Have received prior treatment with an oral janus kinase inhibitor."}, 'identificationModule': {'nctId': 'NCT02265705', 'briefTitle': 'A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy', 'orgStudyIdInfo': {'id': '14875'}, 'secondaryIdInfos': [{'id': 'I4V-CR-JAGS', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baricitinib', 'description': '4 milligrams (mg) baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.\n\nParticipants will continue to take background methotrexate (MTX) therapy throughout study. Other background therapies, including non-steroidal anti-inflammatory drugs (NSAIDs) and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.', 'interventionNames': ['Drug: Baricitinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.\n\nParticipants will continue to take background MTX therapy throughout study. Other background therapies, including NSAIDs and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Baricitinib', 'type': 'DRUG', 'otherNames': ['LY3009104', 'INCB 028050'], 'description': 'Administered orally', 'armGroupLabels': ['Baricitinib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1015ABO', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': 'C1431FWO', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': 'C1440AAD', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': 'S2000CFJ', 'city': 'Rosario', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'J5402DIL', 'city': 'San Juan', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -31.53726, 'lon': -68.52568}}, {'zip': 'T4000AXL', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '01244-030', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04266-010', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '100029', 'city': 'Beijing', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '233004', 'city': 'Bengbu', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '410008', 'city': 'Changsha', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410011', 'city': 'Changsha', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '610041', 'city': 'Chengdu', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '510080', 'city': 'Guangzhou', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '230001', 'city': 'Hefei', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '230022', 'city': 'Hefei', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '250012', 'city': 'Jinan', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '650032', 'city': 'Kunming', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '210029', 'city': 'Nanjing', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '315010', 'city': 'Ningbo', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'zip': '337055', 'city': 'Pingxiang', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.61672, 'lon': 113.85353}}, {'zip': '200001', 'city': 'Shanghai', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200052', 'city': 'Shanghai', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '515041', 'city': 'Shantou', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'zip': '300052', 'city': 'Tianjin', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '430030', 'city': 'Wuhan', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '224005', 'city': 'Yancheng', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.3575, 'lon': 120.1573}}, {'zip': '412007', 'city': 'Zhuzhou', 'country': 'China', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.83333, 'lon': 113.15}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}