Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-01-03 @ 9:01 PM
Study NCT ID:
NCT02708095
Status:
COMPLETED
Last Update Posted:
2018-11-21
First Post:
2016-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Baricitinib (LY3009104) in Participants With 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': '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': 'Up to 32 weeks', 'description': 'All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received Placebo orally once daily (QD) for 24 weeks.', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 27, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '2 mg Baricitinib', 'description': 'Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 36, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': '4 mg Baricitinib', 'description': 'Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 32, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lupus nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo orally once daily (QD) for 24 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000'}, {'value': '58.1', 'groupId': 'OG001'}, {'value': '67.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.392', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.27', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.041', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.84', 'ciLowerLimit': '1.02', 'ciUpperLimit': '3.29', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Participants were defined as responder as follows using SLEDAI-2K definitions of arthritis and rash. If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint. If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint. If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for remission of arthritis and/or rash.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve SLE Responder Index 4 (SRI-4) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo orally once daily (QD) for 24 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}, {'value': '51.4', 'groupId': 'OG001'}, {'value': '64.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.440', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.71', 'ciUpperLimit': '2.19', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.04', 'ciLowerLimit': '1.15', 'ciUpperLimit': '3.62', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "SRI-4 response is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores; and 3) no worsening (defined as an increase of ≥0.3 points \\[10 mm\\] from baseline) in Physician's Global Assessment of Disease Activity. The SRI-4 is a composite index used to assess disease activity in SLE. SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe).", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for SRI-4 response.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SLEDAI-2K Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo orally once daily (QD) for 24 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.82', 'spread': '0.352', 'groupId': 'OG000'}, {'value': '-4.07', 'spread': '0.356', 'groupId': 'OG001'}, {'value': '-4.39', 'spread': '0.353', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.600', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference (Final Vaules)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '0.71', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.243', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference (Final Vaules)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '0.39', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, region, baseline disease activity (SLEDAI-2K \\<10, \\>=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment\\*time (type III sum of squares).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for SLEDAI-2K.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo orally once daily (QD) for 24 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.105', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '0.107', 'groupId': 'OG001'}, {'value': '-1.00', 'spread': '0.105', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.285', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference (Final Vaules)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.13', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference (Final Vaules)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '-0.04', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The Patient\'s Global Assessment of Disease Activity is a single-item, patient reported scale developed for the assessment of the patient\'s overall rating of their disease activity due to SLE. The scale measures disease activity through a 5 point Likert scale ranging from 0 ("No disease activity") to 4 ("Severe disease activity") at its worst over the past 7 days. LS mean was determined by MMRM model with baseline of response, region, baseline disease activity (SLEDAI-2K \\<10, \\>=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment\\*time (type III sum of squares).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for Patient's Global Assessment of Disease Activity."}, {'type': 'SECONDARY', 'title': 'Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg Baricitinib', 'description': 'Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.'}, {'id': 'OG001', 'title': '4 mg Baricitinib', 'description': 'Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '265', 'spread': '55', 'groupId': 'OG000'}, {'value': '569', 'spread': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose', 'description': 'Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. AUC takes all time points post dose into account and one value is reported.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data.'}, {'type': 'SECONDARY', 'title': 'Population Pharmacokinetics (PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg Baricitinib', 'description': 'Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.'}, {'id': 'OG001', 'title': '4 mg Baricitinib', 'description': 'Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '30', 'groupId': 'OG000'}, {'value': '59.2', 'spread': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose', 'description': 'Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. Cmax takes all time points post dose into account and one value is reported.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received Placebo orally once daily (QD) for 24 weeks.'}, {'id': 'FG001', 'title': '2 mg Baricitinib', 'description': 'Participants received 2 (milligrams) mg of Baricitinib tablet orally once a day for 24 weeks.'}, {'id': 'FG002', 'title': '4 mg Baricitinib', 'description': 'Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '105'}, {'groupId': 'FG002', 'numSubjects': '104'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '105'}, {'groupId': 'FG002', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '314', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received Placebo orally once daily (QD) for 24 weeks.'}, {'id': 'BG001', 'title': '2 mg Baricitinib', 'description': 'Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.'}, {'id': 'BG002', 'title': '4 mg Baricitinib', 'description': 'Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.9', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '43.2', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '45.0', 'spread': '12.4', 'groupId': 'BG002'}, {'value': '44.3', 'spread': '12.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '294', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '174', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '204', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-11', 'size': 815312, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-16T00:22', 'hasProtocol': True}, {'date': '2017-07-26', 'size': 1078510, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-08-16T00:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-16', 'studyFirstSubmitDate': '2016-03-10', 'resultsFirstSubmitDate': '2018-09-28', 'studyFirstSubmitQcDate': '2016-03-10', 'lastUpdatePostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-16', 'studyFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)', 'timeFrame': 'Week 24', 'description': 'Participants were defined as responder as follows using SLEDAI-2K definitions of arthritis and rash. If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint. If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint. If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve SLE Responder Index 4 (SRI-4) Response', 'timeFrame': 'Week 24', 'description': "SRI-4 response is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores; and 3) no worsening (defined as an increase of ≥0.3 points \\[10 mm\\] from baseline) in Physician's Global Assessment of Disease Activity. The SRI-4 is a composite index used to assess disease activity in SLE. SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe)."}, {'measure': 'Change From Baseline in SLEDAI-2K Score', 'timeFrame': 'Baseline, Week 24', 'description': 'SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, region, baseline disease activity (SLEDAI-2K \\<10, \\>=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment\\*time (type III sum of squares).'}, {'measure': "Change From Baseline in Patient's Global Assessment of Disease Activity", 'timeFrame': 'Baseline, Week 24', 'description': 'The Patient\'s Global Assessment of Disease Activity is a single-item, patient reported scale developed for the assessment of the patient\'s overall rating of their disease activity due to SLE. The scale measures disease activity through a 5 point Likert scale ranging from 0 ("No disease activity") to 4 ("Severe disease activity") at its worst over the past 7 days. LS mean was determined by MMRM model with baseline of response, region, baseline disease activity (SLEDAI-2K \\<10, \\>=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment\\*time (type III sum of squares).'}, {'measure': 'Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)', 'timeFrame': 'Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose', 'description': 'Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. AUC takes all time points post dose into account and one value is reported.'}, {'measure': 'Population Pharmacokinetics (PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss)', 'timeFrame': 'Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose', 'description': 'Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. Cmax takes all time points post dose into account and one value is reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '35609978', 'type': 'DERIVED', 'citation': 'Dorner T, Tanaka Y, Dow ER, Koch AE, Silk M, Ross Terres JA, Sims JT, Sun Z, de la Torre I, Petri M. Mechanism of action of baricitinib and identification of biomarkers and key immune pathways in patients with active systemic lupus erythematosus. Ann Rheum Dis. 2022 Aug 11;81(9):1267-1272. doi: 10.1136/annrheumdis-2022-222335.'}, {'pmid': '35578304', 'type': 'DERIVED', 'citation': 'Dorner T, van Vollenhoven RF, Doria A, Jia B, Ross Terres JA, Silk ME, de Bono S, Fischer P, Wallace DJ. Baricitinib decreases anti-dsDNA in patients with systemic lupus erythematosus: results from a phase II double-blind, randomized, placebo-controlled trial. Arthritis Res Ther. 2022 May 16;24(1):112. doi: 10.1186/s13075-022-02794-x.'}, {'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.'}, {'pmid': '30043749', 'type': 'DERIVED', 'citation': 'Wallace DJ, Furie RA, Tanaka Y, Kalunian KC, Mosca M, Petri MA, Dorner T, Cardiel MH, Bruce IN, Gomez E, Carmack T, DeLozier AM, Janes JM, Linnik MD, de Bono S, Silk ME, Hoffman RW. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Jul 21;392(10143):222-231. doi: 10.1016/S0140-6736(18)31363-1.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrialguide.com/en-US/studies/lupus/JAHH#?postal=', 'label': 'Click here for more information about this study: A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have received a diagnosis of SLE at least 24 weeks prior to screening, meeting the American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria.\n* Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory at screening.\n* Have a SLEDAI-2K score ≥4 based on clinical symptoms (not including lab values) at randomization.\n* Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.\n\nExclusion Criteria:\n\n* Have active severe lupus nephritis.\n* Have active severe central nervous system (CNS) lupus.\n* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.\n* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.\n* Are currently receiving oral corticosteroids at doses \\>20-milligrams per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.\n* Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 4 weeks of planned randomization.\n* Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of planned randomization.\n* Have started treatment with or adjusted the dose of an immunosuppressant within 12 weeks of planned randomization.\n* Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.'}, 'identificationModule': {'nctId': 'NCT02708095', 'briefTitle': 'A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of 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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': 'T4000BRD', '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': '8036', 'city': 'Graz', 'country': 'Austria', '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': 47.06733, 'lon': 15.44197}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', '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': 48.20849, 'lon': 16.37208}}, {'zip': '1130', 'city': 'Vienna', 'country': 'Austria', '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': 48.20849, 'lon': 16.37208}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', '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': 44.84124, 'lon': -0.58046}}, {'zip': '13003', 'city': 'Marseille', 'country': 'France', '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': 43.29695, 'lon': 5.38107}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', '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': 44.80565, 'lon': -0.6324}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', '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': 48.58392, 'lon': 7.74553}}, {'zip': '070-8644', 'city': 'Asahikawa', 'country': 'Japan', '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': 43.77063, 'lon': 142.36489}}, {'zip': '104-8560', 'city': 'Chūōku', 'country': 'Japan', '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': 33.63867, 'lon': 130.67068}}, {'zip': '810-8563', 'city': 'Fukuoka', 'country': 'Japan', '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': 33.6, 'lon': 130.41667}}, {'zip': '430-8558', 'city': 'Hamamatsu', 'country': 'Japan', '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': 34.7, 'lon': 137.73333}}, {'zip': '173-8610', 'city': 'Itabashi-ku', 'country': 'Japan', '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': '350-8550', 'city': 'Kawagoe', 'country': 'Japan', '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': 35.90861, 'lon': 139.48528}}, {'zip': '761-0793', 'city': 'Kita-gun', 'country': 'Japan', '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': '807-8556', 'city': 'Kitakyushu', 'country': 'Japan', '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': 33.85181, 'lon': 130.85034}}, {'zip': '153-8515', 'city': 'Meguro-ku', 'country': 'Japan', 'facility': 'Meguro-kuFor 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': '852-8501', 'city': 'Nagasaki', 'country': 'Japan', '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': 32.75, 'lon': 129.88333}}, {'zip': '856-8562', 'city': 'Ōmura', 'country': 'Japan', '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': 32.92139, 'lon': 129.95389}}, {'zip': '060-8648', 'city': 'Sapporo', 'country': 'Japan', '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': 43.06667, 'lon': 141.35}}, {'zip': '857-1195', 'city': 'Sasebo', 'country': 'Japan', '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': 33.16834, 'lon': 129.72502}}, {'zip': '980-8574', 'city': 'Sendai', 'country': 'Japan', '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': 38.26667, 'lon': 140.86667}}, {'zip': '44650', 'city': 'Guadalajara', 'country': 'Mexico', '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': 20.67738, 'lon': -103.34749}}, {'zip': '44690', 'city': 'Guadalajara', 'country': 'Mexico', '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': 20.67738, 'lon': -103.34749}}, {'zip': '06700', 'city': 'Mexico City', 'country': 'Mexico', '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': 19.42847, 'lon': -99.12766}}, {'zip': '45030', 'city': 'Zapopan', 'country': 'Mexico', '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': 20.72111, 'lon': -103.38742}}, {'zip': '85-168', 'city': 'Bydgoszcz', 'country': 'Poland', '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': 53.1235, 'lon': 18.00762}}, {'zip': '41-902', 'city': 'Bytom', 'country': 'Poland', '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': 50.34802, 'lon': 18.93282}}, {'zip': '82-300', 'city': 'Elblag', 'country': 'Poland', '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': 54.1522, 'lon': 19.40884}}, {'zip': '80-546', 'city': 'Gdansk', 'country': 'Poland', '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': 54.35227, 'lon': 18.64912}}, {'zip': '05-830', 'city': 'Nadarzyn', 'country': 'Poland', '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': 52.09438, 'lon': 20.80776}}, {'zip': '21-040', 'city': 'Świdnik', 'country': 'Poland', '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': 51.21898, 'lon': 22.69621}}, {'zip': '00725', 'city': 'Caguas', 'country': 'Puerto Rico', 'facility': 'Office: Perez-De Jesus, Amarilis', 'geoPoint': {'lat': 18.23412, 'lon': -66.0485}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Mindful Medical Research', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00909', 'city': 'Santurce', 'country': 'Puerto Rico', 'facility': 'Latin Clinical Trial Center', 'geoPoint': {'lat': 18.19523, 'lon': -67.14018}}, {'zip': '500283', 'city': 'Brasov', 'country': 'Romania', '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': 45.64861, 'lon': 25.60613}}, {'zip': '011172', 'city': 'Bucharest', 'country': 'Romania', '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': 44.43225, 'lon': 26.10626}}, {'zip': '800587', 'city': 'Galati', 'country': 'Romania', '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': 45.43687, 'lon': 28.05028}}, {'zip': '540136', 'city': 'Târgu Mureş', 'country': 'Romania', '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': 46.54245, 'lon': 24.55747}}, {'zip': '61469', 'city': 'Gwangju', 'country': 'South Korea', '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': 35.15472, 'lon': 126.91556}}, {'zip': '22332', 'city': 'Incheon', 'country': 'South Korea', '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': 37.45646, 'lon': 126.70515}}, {'zip': '02447', 'city': 'Seoul', 'country': 'South Korea', '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': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', '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': 37.566, 'lon': 126.9784}}, {'zip': '16499', 'city': 'Suwon', 'country': 'South Korea', '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': 37.29111, 'lon': 127.00889}}, {'zip': '08916', 'city': 'Badalona', 'country': 'Spain', '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': 41.45004, 'lon': 2.24741}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', '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': 41.38879, 'lon': 2.15899}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', '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': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', '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': 40.4165, 'lon': -3.70256}}, {'zip': '36200', 'city': 'Vigo', 'country': 'Spain', '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': 42.23282, 'lon': -8.72264}}, {'zip': '83301', 'city': 'Kaohsiung City', 'country': 'Taiwan', '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': 22.61626, 'lon': 120.31333}}, {'zip': '40201', 'city': 'Taichung', 'country': 'Taiwan', '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': 24.1469, 'lon': 120.6839}}, {'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', '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': 24.1469, 'lon': 120.6839}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', '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': 25.05306, 'lon': 121.52639}}], '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}