Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-29 @ 2:27 AM
Study NCT ID:
NCT04972968
Status:
TERMINATED
Last Update Posted:
2024-10-15
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011111', 'term': 'Polymyalgia Rheumatica'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005938', 'term': 'Glucocorticoids'}], 'ancestors': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "AbbVie has decided to discontinue further subject enrollment in the M20-370 (ABBV-154) study. This decision is not based on a safety or an efficacy signal; rather this decision was made because of a change in AbbVie's development."}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality were reported from enrollment to the end of study, median time on follow up was 288.5, 292.0, 300.0, and 299.0 Days for Placebo and ABBV-154 (40mg/150mg/340mg), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug within 70 days after the last dose of study drug; mean duration on study drug was 235.2, 239.9, 234.6 and 230.3 days for Placebo and ABBV-154 (40mg/150mg/340mg), respectively.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nPlacebo: Subcutaneous Injection Glucocorticoid: Oral Tablet', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 27, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'ABBV-154 40mg SC', 'description': 'Participants in this group received 40mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nABBV-154: Subcutaneous Injection Glucocorticoid: Oral Tablet', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 25, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'ABBV-154 150mg SC', 'description': 'Participants in this group received 150mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nABBV-154: Subcutaneous Injection Glucocorticoid: Oral Tablet', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 30, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'ABBV-154 340mg SC', 'description': 'Participants in this group received 340mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nABBV-154: Subcutaneous Injection Glucocorticoid: Oral Tablet', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 37, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'INJECTION SITE RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'SKIN LACERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ROTATOR CUFF SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HYPERHIDROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'LEFT VENTRICULAR FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'SUPRAVENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'VENTRICULAR EXTRASYSTOLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ATRIAL SEPTAL DEFECT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PANCREATIC PSEUDOCYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PANCREATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CHOLANGITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'APPENDICITIS PERFORATED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PERITONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PNEUMONIA PNEUMOCOCCAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'UROSEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ACUTE MYELOID LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'SCIATICA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'THALAMIC INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'FEMALE GENITAL TRACT FISTULA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DYSPNOEA AT REST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Flare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will receive placebo SC EOW for 24 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.\n\nPlacebo: Subcutaneous Injection\n\nGlucocorticoid: Oral Tablet'}, {'id': 'OG001', 'title': 'ABBV-154, 40mg SC', 'description': 'Participants in this group received 40mg dose of ABBV-154 SC EOW for 24 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nABBV-154: 40mg SC\n\nGlucocorticoid: Oral Tablet'}, {'id': 'OG002', 'title': 'ABBV-154, 150mg SC', 'description': 'Participants in this group received 150mg dose of ABBV-154 SC EOW for 24 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nABBV-154: 150mg SC\n\nGlucocorticoid: Oral Tablet'}, {'id': 'OG003', 'title': 'ABBV-154, 340mg SC', 'description': 'Participants in this group received 340mg dose of ABBV-154 SC EOW for 24 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nABBV-154: 340mg SC\n\nGlucocorticoid: Oral Tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '141'}, {'value': '225', 'comment': 'Not calculable/estimable due to low number of participants with flares', 'groupId': 'OG001', 'lowerLimit': '140', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not calculable/estimable due to low number of participants with flares', 'groupId': 'OG002', 'lowerLimit': '141', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not calculable/estimable due to low number of participants with flares', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.490', 'ciLowerLimit': '0.273', 'ciUpperLimit': '0.878', 'pValueComment': 'P-value \\<= 0.05', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by baseline randomization stratification factors \\[Glucocorticoid use at Baseline (\\>= 10 mg/day; \\< 10 mg/day prednisone equivalent)\\].'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.443', 'ciLowerLimit': '0.248', 'ciUpperLimit': '0.794', 'pValueComment': 'P-value \\<= 0.01', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by baseline randomization stratification factors \\[Glucocorticoid use at Baseline (\\>= 10 mg/day; \\< 10 mg/day prednisone equivalent)\\]'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.198', 'ciLowerLimit': '0.094', 'ciUpperLimit': '0.419', 'pValueComment': 'P-value \\<= 0.001', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by baseline randomization stratification factors \\[Glucocorticoid use at Baseline (\\>= 10 mg/day; \\< 10 mg/day prednisone equivalent)\\]'}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug to Week 52', 'description': 'Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Flare-Free State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.'}, {'id': 'OG001', 'title': 'ABBV-154 40mg SC', 'description': 'Participants in this group received 40mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.'}, {'id': 'OG002', 'title': 'ABBV-154 150mg SC', 'description': 'Participants in this group received 150mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.'}, {'id': 'OG003', 'title': 'ABBV-154 340mg SC', 'description': 'Participants in this group received 340mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.107', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.7', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '41.4', 'estimateComment': 'From Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \\[Glucocorticoid (GC) use at baseline (≥ 10 mg/day; \\< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \\> 1 year)\\].', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.092', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.9', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '41.0', 'pValueComment': 'P-value ≤ 0.1', 'estimateComment': 'Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \\[Glucocorticoid use at baseline (≥ 10 mg/day; \\< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \\> 1 year)\\].', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.9', 'ciLowerLimit': '21.4', 'ciUpperLimit': '62.3', 'pValueComment': 'P-value ≤ 0.001', 'estimateComment': 'Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \\[Glucocorticoid use at baseline (≥ 10 mg/day; \\< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \\> 1 year)\\].', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'description': 'Percentage of participants achieving flare-free state.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with data available for analysis'}, {'type': 'SECONDARY', 'title': 'Cumulative Glucocorticoid Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.'}, {'id': 'OG001', 'title': 'ABBV-154 40mg SC', 'description': 'Participants in this group received 40mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.'}, {'id': 'OG002', 'title': 'ABBV-154 150mg SC', 'description': 'Participants in this group received 150mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.'}, {'id': 'OG003', 'title': 'ABBV-154 340mg SC', 'description': 'Participants in this group received 340mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '984.576', 'spread': '524.6579', 'groupId': 'OG000'}, {'value': '823.411', 'spread': '397.9403', 'groupId': 'OG001'}, {'value': '734.310', 'spread': '332.3137', 'groupId': 'OG002'}, {'value': '759.450', 'spread': '381.1683', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.144', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-88.67', 'ciLowerLimit': '-208.04', 'ciUpperLimit': '30.71', 'estimateComment': '95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \\[GC use at baseline (≥ 10 mg/day; \\< 10 mg/day prednisone equivalent);', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors.'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-164.76', 'ciLowerLimit': '-283.62', 'ciUpperLimit': '-45.89', 'pValueComment': 'P-value ≤ 0.01', 'estimateComment': 'P-value and 95% CI are based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \\[Glucocorticoid use at baseline (≥ 10 mg/day; \\< 10 mg/day prednisone\\] equivalent);', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-182.55', 'ciLowerLimit': '-300.52', 'ciUpperLimit': '-64.58', 'pValueComment': 'P-value ≤ 0.01', 'estimateComment': 'P-value and 95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \\[Glucocorticoid use at baseline (≥ 10 mg/day; \\< 10 mg/day prednisone equivalent)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Cumulative glucocorticoid dose.', 'unitOfMeasure': 'Glucocorticoid dose (mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with data available for analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glucocorticoid Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.'}, {'id': 'OG001', 'title': 'ABBV-154 40mg SC', 'description': 'Participants in this group received 40mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.'}, {'id': 'OG002', 'title': 'ABBV-154 150mg SC', 'description': 'Participants in this group received 150mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.'}, {'id': 'OG003', 'title': 'ABBV-154 340mg SC', 'description': 'Participants in this group received 340mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.96', 'spread': '3.943', 'groupId': 'OG000'}, {'value': '-6.29', 'spread': '3.384', 'groupId': 'OG001'}, {'value': '-7.40', 'spread': '3.554', 'groupId': 'OG002'}, {'value': '-7.88', 'spread': '3.398', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.58', 'ciLowerLimit': '-3.08', 'ciUpperLimit': '-0.08', 'pValueComment': 'P-value \\<= 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value based on ANCOVA adjusting for baseline randomization stratification factors (GC use at baseline)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.66', 'ciLowerLimit': '-4.15', 'ciUpperLimit': '-1.16', 'pValueComment': 'P-value \\<= 0.001', 'estimateComment': '95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.00', 'ciLowerLimit': '-4.49', 'ciUpperLimit': '-1.52', 'pValueComment': 'P-value \\<= 0.001', 'estimateComment': '95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)'}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Change from Baseline in glucocorticoid dose.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population with data available for analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.\n\nPlacebo: Subcutaneous Injection\n\nGlucocorticoid: Oral Tablet'}, {'id': 'FG001', 'title': 'ABBV-154, 40mg SC', 'description': 'Participants in this group received 40mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nABBV-154: 40mg SC\n\nGlucocorticoid: Oral Tablet'}, {'id': 'FG002', 'title': 'ABBV-154, 150mg SC', 'description': 'Participants in this group received 150mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nABBV-154: 150mg SC\n\nGlucocorticoid: Oral Tablet'}, {'id': 'FG003', 'title': 'ABBV-154, 340mg SC', 'description': 'Participants in this group received 340mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nABBV-154: 340mg SC\n\nGlucocorticoid: Oral Tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'In this Double-Blind study, 181 glucocorticoid dependent PMR subjects were randomized into 4 groups and dosed for 52 weeks. Subjects were dosed SC: Placebo, ABBV-154 (40mg,150mg, or 340mg) with a glucocorticoid taper EOW. Beginning at Week 3, subjects were to taper prednisone/prednisolone per the protocol-defined glucocorticoid taper schedule to 0mg prednisone equivalent by Week 24.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '181', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nPlacebo: Subcutaneous Injection Glucocorticoid: Oral Tablet'}, {'id': 'BG001', 'title': 'ABBV-154 40mg SC', 'description': 'Participants in this group received 40mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nABBV-154: Subcutaneous Injection Glucocorticoid: Oral Tablet'}, {'id': 'BG002', 'title': 'ABBV-154 150mg SC', 'description': 'Participants in this group received 150mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nABBV-154: Subcutaneous Injection Glucocorticoid: Oral Tablet'}, {'id': 'BG003', 'title': 'ABBV-154 340mg SC', 'description': 'Participants in this group received 340mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper.\n\nABBV-154: Subcutaneous Injection Glucocorticoid: Oral Tablet'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.0', 'spread': '7.15', 'groupId': 'BG000'}, {'value': '67.5', 'spread': '7.98', 'groupId': 'BG001'}, {'value': '69.8', 'spread': '8.34', 'groupId': 'BG002'}, {'value': '69.1', 'spread': '6.23', 'groupId': 'BG003'}, {'value': '69.4', 'spread': '7.50', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '176', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Glucocorticoid Dose (mg/day)', 'classes': [{'categories': [{'measurements': [{'value': '9.21', 'spread': '3.801', 'groupId': 'BG000'}, {'value': '9.45', 'spread': '3.378', 'groupId': 'BG001'}, {'value': '9.10', 'spread': '3.519', 'groupId': 'BG002'}, {'value': '9.52', 'spread': '3.317', 'groupId': 'BG003'}, {'value': '9.31', 'spread': '3.495', 'groupId': 'BG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'unitOfMeasure': 'mg/day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-21', 'size': 2829045, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-18T13:15', 'hasProtocol': True}, {'date': '2022-08-03', 'size': 428517, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-18T13:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'whyStopped': 'Strategic considerations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2021-07-13', 'resultsFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2021-07-13', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-10', 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Flare', 'timeFrame': 'From first dose of study drug to Week 52', 'description': 'Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Flare-Free State', 'timeFrame': 'Up to Week 24', 'description': 'Percentage of participants achieving flare-free state.'}, {'measure': 'Cumulative Glucocorticoid Dose', 'timeFrame': 'Week 24', 'description': 'Cumulative glucocorticoid dose.'}, {'measure': 'Change From Baseline in Glucocorticoid Dose', 'timeFrame': 'Week 24', 'description': 'Change from Baseline in glucocorticoid dose.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polymyalgia Rheumatica', 'PMR', 'ABBV-154', 'Glucocorticoid'], 'conditions': ['Polymyalgia Rheumatica']}, 'descriptionModule': {'briefSummary': 'Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed.\n\nABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide.\n\nThe study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow).\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Polymyalgia Rheumatica (PMR) and fulfillment of the 2012 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) provisional classification criteria for PMR.\n* Must have had at least 2 episodes of unequivocal PMR flare.\n* Must be on a stable dose of prednisone.\n* Must be willing to follow the protocol-defined glucocorticoid tapering regimen.\n\nExclusion Criteria:\n\n* Have been treated with a prior TNF antagonist.\n* Current use of immunomodulators other than prednisone and hydroxychloroquine.'}, 'identificationModule': {'nctId': 'NCT04972968', 'acronym': 'AIM-PMR', 'briefTitle': 'A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment', 'orgStudyIdInfo': {'id': 'M20-370'}, 'secondaryIdInfos': [{'id': '2021-000648-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABBV-154 Dose A', 'description': 'Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.', 'interventionNames': ['Drug: ABBV-154', 'Drug: Glucocorticoid']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-154 Dose B', 'description': 'Participants in this group will receive dose B of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.', 'interventionNames': ['Drug: ABBV-154', 'Drug: Glucocorticoid']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-154 Dose C', 'description': 'Participants in this group will receive dose C of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.', 'interventionNames': ['Drug: ABBV-154', 'Drug: Glucocorticoid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.', 'interventionNames': ['Drug: Placebo', 'Drug: Glucocorticoid']}], 'interventions': [{'name': 'ABBV-154', 'type': 'DRUG', 'description': 'Subcutaneous Injection', 'armGroupLabels': ['ABBV-154 Dose A', 'ABBV-154 Dose B', 'ABBV-154 Dose C']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous Injection', 'armGroupLabels': ['Placebo']}, {'name': 'Glucocorticoid', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['ABBV-154 Dose A', 'ABBV-154 Dose B', 'ABBV-154 Dose C', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401-6251', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arthritis and Rheumatism Associates /ID# 232089', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Providence Medical Foundation /ID# 228681', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Care Access Research, Huntington Beach /ID# 228677', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Purushotham & Akther Kotha MD, Inc /ID# 245391', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90623-1728', 'city': 'La Palma', 'state': 'California', 'country': 'United States', 'facility': 'Arthritis & Osteo Medical Ctr /ID# 228680', 'geoPoint': {'lat': 33.8464, 'lon': -118.04673}}, {'zip': '93108', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Hans Richard Barthel, M.D., Inc /ID# 231902', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '91042-2706', 'city': 'Tujunga', 'state': 'California', 'country': 'United States', 'facility': 'Medvin Clinical Research /ID# 228675', 'geoPoint': {'lat': 34.25223, 'lon': -118.28841}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Inland Rheum & Osteo Med Grp /ID# 228679', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Arthritis Clinic /ID# 245736', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '19958', 'city': 'Lewes', 'state': 'Delaware', 'country': 'United States', 'facility': 'Delaware Arthritis /ID# 230110', 'geoPoint': {'lat': 38.77456, 'lon': -75.13935}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Arthritis & Rheumatic Disease Specialties /ID# 245448', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'International Medical Research /ID# 228765', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '32713-2260', 'city': 'DeBary', 'state': 'Florida', 'country': 'United States', 'facility': 'Omega Research Debary, LLC /ID# 245450', 'geoPoint': {'lat': 28.88305, 'lon': -81.30868}}, {'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Lakes Research, LLC /ID# 228757', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32819', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'HMD Research LLC /ID# 228767', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '62702-3749', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Springfield Clinic /ID# 228840', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '42001', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Four Rivers Clinical Research /ID# 228858', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '38801-4949', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Rheumatology Consultants - 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Tomball /ID# 245512', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '2019', 'city': 'Botany', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Emeritus Research Sydney /ID# 229166', 'geoPoint': {'lat': -33.94599, 'lon': 151.19591}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital /ID# 244888', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2150', 'city': 'Paramatta', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'BJC Health /ID# 244839'}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Tasman Health Care /ID# 230829', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '5011', 'city': 'Woodville South', 'state': 'South Australia', 'country': 'Australia', 'facility': 'The Queen Elizabeth Hospital /ID# 229049', 'geoPoint': {'lat': -34.88186, 'lon': 138.53477}}, {'zip': '3124', 'city': 'Camberwell', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Emeritus Research /ID# 229270', 'geoPoint': {'lat': -37.84205, 'lon': 145.0694}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health /ID# 229164', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '6150', 'city': 'Murdoch', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Fiona Stanley Hospital /ID# 229050', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'zip': '1100', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'T5M 0H4', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Rheumatology Research Associates /ID# 230363', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'L4M 6L2', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Waterside Clinic /ID# 230364', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'G5L 5T1', 'city': 'Rimouski', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CISSSBSL -Hopital regional de Rimouski /ID# 228394', 'geoPoint': {'lat': 48.44879, 'lon': -68.52396}}, {'zip': 'G8Z 1Y2', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Recherche Musculo-Squelettique /ID# 228392', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': '25030', 'city': 'Besançon', 'state': 'Doubs', 'country': 'France', 'facility': 'CHU de Besancon - 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This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}