Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-25 @ 11:52 AM
Study NCT ID:
NCT02919761
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2016-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000324', 'term': 'Adrenocorticotropic Hormone'}], 'ancestors': [{'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@mnk.com', 'phone': '800-556-3314', 'title': 'Medical Information Call Center', 'organization': 'Mallinckrodt'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected during an active treatment period of 24 weeks, and a follow-up visit of 28 (± 2) days after last dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: All Participants Enrolled', 'description': 'All participants enrolled in the trial with AEs during Part 1', 'otherNumAtRisk': 259, 'deathsNumAtRisk': 259, 'otherNumAffected': 26, 'seriousNumAtRisk': 259, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Part 2: Placebo', 'description': 'Participants who received Placebo in Part 2 with AEs during Part 2', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 26, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 2: Acthar Gel', 'description': 'Participants who received Acthar Gel in Part 2 with AEs during Part 2', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 22, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Number of Participants With Low Disease Activity (LDA) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: All Participants Enrolled', 'description': 'All participants who enrolled in the trial'}], 'classes': [{'title': 'at Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'at Week 4', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'at Week 8', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'at Week 12', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=0.242', 'groupIds': ['OG000'], 'pValueComment': 'At Week 4', 'statisticalMethod': 'One-sample binomial test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'pValueComment': 'At Week 8', 'statisticalMethod': 'One-sample binomial test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'One-sample binomial test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'LDA is defined as DAS28 \\<3.2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent to Treat (mITT) Population'}, {'type': 'PRIMARY', 'title': 'Part 2: Number of Participants Who Maintained Low Disease Activity by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Placebo', 'description': 'Participants receive Placebo 1 mL twice weekly during Part 2, from Week 12 through week 24'}, {'id': 'OG001', 'title': 'Part 2: Acthar Gel', 'description': 'Participants receive Acthar Gel 1 mL twice weekly during Part 2, from Week 12 through Week 24'}], 'classes': [{'title': 'at Week 12', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'at Week 16', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'at Week 20', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'at Week 24', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.313', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Comparison at Week 12', 'statisticalMethod': "Pearson's Chi-square test", 'nonInferiorityType': 'OTHER'}, {'pValue': '=0.439', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Comparison at Week 16', 'statisticalMethod': "Pearson's Chi-square test", 'nonInferiorityType': 'OTHER'}, {'pValue': '=0.028', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Comparison at Week 20', 'statisticalMethod': "Pearson's Chi-square test", 'nonInferiorityType': 'OTHER'}, {'pValue': '=0.019', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Comparison at Week 24', 'statisticalMethod': "Pearson's Chi-square test", 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12 to Week 24', 'description': 'Low disease activity is defined as DAS28 \\<3.2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Part 1: Swollen Joint Count by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}, {'units': 'Joints', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: All Participants Enrolled', 'description': 'All participants who enrolled in the trial'}], 'classes': [{'title': 'at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}, {'units': 'Joints', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '5.37', 'groupId': 'OG000'}]}]}, {'title': 'at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}, {'units': 'Joints', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '4.88', 'groupId': 'OG000'}]}]}, {'title': 'at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}, {'units': 'Joints', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '4.36', 'groupId': 'OG000'}]}]}, {'title': 'at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}, {'units': 'Joints', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '4.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': "The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)\n\nThe DAS28 is a composite score derived from the following assessments:\n\n* Swollen Joint Count\n* Tender Joint Count\n* Patient's Global Health\n* Erythrocyte Sedimentation Rate", 'unitOfMeasure': 'Count of swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Joints', 'denomUnitsSelected': 'Joints', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Part 2: Swollen Joint Count by Visit During Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'Joints', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Placebo', 'description': 'Participants receive Placebo during Part 2'}, {'id': 'OG001', 'title': 'Part 2: Acthar Gel', 'description': 'Participants who receive Acthar Gel during Part 2'}], 'classes': [{'title': 'at Baseline', 'categories': [{'measurements': [{'value': '10.1', 'spread': '4.87', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '4.32', 'groupId': 'OG001'}]}]}, {'title': 'at Week 12', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'at Week 16', 'categories': [{'measurements': [{'value': '1.7', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.31', 'groupId': 'OG001'}]}]}, {'title': 'at Week 20', 'categories': [{'measurements': [{'value': '1.9', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': 'at Week 24', 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '2.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 to Week 24', 'description': "The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR/DAS28)\n\nThe DAS28 is a composite score derived from the following assessments:\n\n* Swollen Joint Count\n* Tender Joint Count\n* Patient's Global Health\n* Erythrocyte Sedimentation Rate", 'unitOfMeasure': 'Count of swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Joints', 'denomUnitsSelected': 'Joints', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Part 1: Tender Joint Count by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}, {'units': 'Joints', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: All Participants Enrolled', 'description': 'All participants who enrolled in the trial'}], 'classes': [{'title': 'at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}, {'units': 'Joints', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.7', 'spread': '7.08', 'groupId': 'OG000'}]}]}, {'title': 'at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}, {'units': 'Joints', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '6.39', 'groupId': 'OG000'}]}]}, {'title': 'at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}, {'units': 'Joints', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '5.93', 'groupId': 'OG000'}]}]}, {'title': 'at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}, {'units': 'Joints', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '5.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': "The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)\n\nThe DAS28 is a composite score derived from the following assessments:\n\n* Swollen Joint Count\n* Tender Joint Count\n* Patient's Global Health\n* Erythrocyte Sedimentation Rate", 'unitOfMeasure': 'Count of Tender Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Joints', 'denomUnitsSelected': 'Joints', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Part 2: Tender Joint Count by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'Joints', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Placebo', 'description': 'Participants who receive Placebo during Part 2'}, {'id': 'OG001', 'title': 'Part 2: Acthar Gel', 'description': 'Participants who receive Acthar Gel during Part 2'}], 'classes': [{'title': 'at Baseline', 'categories': [{'measurements': [{'value': '13.5', 'spread': '7.24', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '6.41', 'groupId': 'OG001'}]}]}, {'title': 'at Week 12', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': 'at Week 16', 'categories': [{'measurements': [{'value': '2.6', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.47', 'groupId': 'OG001'}]}]}, {'title': 'at Week 20', 'categories': [{'measurements': [{'value': '2.7', 'spread': '4.36', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.67', 'groupId': 'OG001'}]}]}, {'title': 'at Week 24', 'categories': [{'measurements': [{'value': '3.1', 'spread': '4.46', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '4.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 to Week 24', 'description': "The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)\n\nThe DAS28 is a composite score derived from the following assessments:\n\n* Swollen Joint Count\n* Tender Joint Count\n* Patient's Global Health\n* Erythrocyte Sedimentation Rate", 'unitOfMeasure': 'Count of Tender Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Joints', 'denomUnitsSelected': 'Joints', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Part 1: Patient-Reported General Health by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: All Participants Enrolled', 'description': 'All participants who enrolled in the trial'}], 'classes': [{'title': 'at Baseline', 'categories': [{'measurements': [{'value': '59.8', 'spread': '20.02', 'groupId': 'OG000'}]}]}, {'title': 'at Week 4', 'categories': [{'measurements': [{'value': '45.1', 'spread': '23.15', 'groupId': 'OG000'}]}]}, {'title': 'at Week 8', 'categories': [{'measurements': [{'value': '37.8', 'spread': '22.95', 'groupId': 'OG000'}]}]}, {'title': 'at Week 12', 'categories': [{'measurements': [{'value': '27.0', 'spread': '22.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.\n\nA lower score indicates better general health.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Part 2: Patient-Reported General Health by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Placebo', 'description': 'Participants who receive Placebo during Part 2'}, {'id': 'OG001', 'title': 'Part 2: Acthar Gel', 'description': 'Participants who receive Acthar Gel during Part 2'}], 'classes': [{'title': 'at Baseline', 'categories': [{'measurements': [{'value': '13.5', 'spread': '7.24', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '6.41', 'groupId': 'OG001'}]}]}, {'title': 'at Week 12', 'categories': [{'measurements': [{'value': '15.4', 'spread': '14.47', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '14.34', 'groupId': 'OG001'}]}]}, {'title': 'at Week 16', 'categories': [{'measurements': [{'value': '17.2', 'spread': '18.16', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '17.98', 'groupId': 'OG001'}]}]}, {'title': 'at Week 20', 'categories': [{'measurements': [{'value': '18.5', 'spread': '20.14', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '16.04', 'groupId': 'OG001'}]}]}, {'title': 'at Week 24', 'categories': [{'measurements': [{'value': '21.4', 'spread': '22.56', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '21.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 to Week 24', 'description': 'Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.\n\nA lower score indicates better general health.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: All Participants Enrolled', 'description': 'All participants who enrolled in the trial'}], 'classes': [{'title': 'at Baseline', 'categories': [{'measurements': [{'value': '43.6', 'spread': '24.77', 'groupId': 'OG000'}]}]}, {'title': 'at Week 4', 'categories': [{'measurements': [{'value': '35.4', 'spread': '23.04', 'groupId': 'OG000'}]}]}, {'title': 'at Week 8', 'categories': [{'measurements': [{'value': '30.6', 'spread': '21.24', 'groupId': 'OG000'}]}]}, {'title': 'at Week 12', 'categories': [{'measurements': [{'value': '24.0', 'spread': '21.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': "The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.\n\nThe clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).\n\nThe normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.\n\nThe ESR is a common test for inflammation and used to derive the DAS28.\n\nThe DAS28 is a composite score derived from the following assessments:\n\n* Swollen Joint Count\n* Tender Joint Count\n* Patient's Global Health\n* Erythrocyte Sedimentation Rate", 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Placebo', 'description': 'Participants who receive Placebo during Part 2'}, {'id': 'OG001', 'title': 'Part 2: Acthar Gel', 'description': 'Participants who receive Acthar Gel during Part 2'}], 'classes': [{'title': 'at Baseline', 'categories': [{'measurements': [{'value': '42.2', 'spread': '23.05', 'groupId': 'OG000'}, {'value': '40.3', 'spread': '21.47', 'groupId': 'OG001'}]}]}, {'title': 'at Week 12', 'categories': [{'measurements': [{'value': '15.2', 'spread': '12.669', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '12.21', 'groupId': 'OG001'}]}]}, {'title': 'at Week 16', 'categories': [{'measurements': [{'value': '19.6', 'spread': '14.62', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '14.42', 'groupId': 'OG001'}]}]}, {'title': 'at Week 20', 'categories': [{'measurements': [{'value': '22.0', 'spread': '17.75', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '13.67', 'groupId': 'OG001'}]}]}, {'title': 'at Week 24', 'categories': [{'measurements': [{'value': '25.1', 'spread': '18.81', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '16.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 to Week 24', 'description': "The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.\n\nThe clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).\n\nThe normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.\n\nThe ESR is a common test for inflammation and used to derive the DAS28.\n\nThe DAS28 is a composite score derived from the following assessments:\n\n* Swollen Joint Count\n* Tender Joint Count\n* Patient's Global Health\n* Erythrocyte Sedimentation Rate", 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': "Part 1: Patient's Global Assessment of Pain by Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: All Participants Enrolled', 'description': 'All participants who enrolled in the trial'}], 'classes': [{'title': 'at Baseline', 'categories': [{'measurements': [{'value': '64.9', 'spread': '20.36', 'groupId': 'OG000'}]}]}, {'title': 'at Week 4', 'categories': [{'measurements': [{'value': '44.1', 'spread': '23.78', 'groupId': 'OG000'}]}]}, {'title': 'at Week 8', 'categories': [{'measurements': [{'value': '37.3', 'spread': '22.92', 'groupId': 'OG000'}]}]}, {'title': 'at Week 12', 'categories': [{'measurements': [{'value': '27.5', 'spread': '23.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': "Part 2: Patient's Global Assessment of Pain by Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Placebo', 'description': 'Participants who receive Placebo during Part 2'}, {'id': 'OG001', 'title': 'Part 2: Acthar Gel', 'description': 'Participants who receive Acthar Gel during Part 2'}], 'classes': [{'title': 'at Baseline', 'categories': [{'measurements': [{'value': '62.8', 'spread': '21.02', 'groupId': 'OG000'}, {'value': '65.7', 'spread': '18.65', 'groupId': 'OG001'}]}]}, {'title': 'at Week 12', 'categories': [{'measurements': [{'value': '17.0', 'spread': '16.00', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '16.64', 'groupId': 'OG001'}]}]}, {'title': 'at Week 16', 'categories': [{'measurements': [{'value': '21.6', 'spread': '21.72', 'groupId': 'OG000'}, {'value': '22.1', 'spread': '20.77', 'groupId': 'OG001'}]}]}, {'title': 'at Week 20', 'categories': [{'measurements': [{'value': '20.0', 'spread': '20.21', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '16.23', 'groupId': 'OG001'}]}]}, {'title': 'at Week 24', 'categories': [{'measurements': [{'value': '22.1', 'spread': '20.50', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '19.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 to Week 24', 'description': 'Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': "Part 1: Physician's Global Assessment of Disease Activities by Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: All Participants Enrolled', 'description': 'All participants who enrolled in the trial'}], 'classes': [{'title': 'at Baseline', 'categories': [{'measurements': [{'value': '64.3', 'spread': '14.93', 'groupId': 'OG000'}]}]}, {'title': 'at Week 4', 'categories': [{'measurements': [{'value': '36.1', 'spread': '18.90', 'groupId': 'OG000'}]}]}, {'title': 'at Week 8', 'categories': [{'measurements': [{'value': '29.0', 'spread': '18.92', 'groupId': 'OG000'}]}]}, {'title': 'at Week 12', 'categories': [{'measurements': [{'value': '21.0', 'spread': '19.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': "The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': "Part 2: Physician's Global Assessment of Disease Activities by Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Placebo', 'description': 'Participants who receive Placebo during Part 2'}, {'id': 'OG001', 'title': 'Part 2: Acthar Gel', 'description': 'Participants who receive Acthar Gel during Part 2'}], 'classes': [{'title': 'at Week 12', 'categories': [{'measurements': [{'value': '11.5', 'spread': '8.91', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '11.49', 'groupId': 'OG001'}]}]}, {'title': 'at Week 16', 'categories': [{'measurements': [{'value': '15.5', 'spread': '15.57', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '13.78', 'groupId': 'OG001'}]}]}, {'title': 'at Week 20', 'categories': [{'measurements': [{'value': '15.9', 'spread': '16.25', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '8.61', 'groupId': 'OG001'}]}]}, {'title': 'at Week 24', 'categories': [{'measurements': [{'value': '17.8', 'spread': '18.12', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '16.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 to Week 24', 'description': "The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Enrolled Participants', 'description': 'All participants who enrolled in the trial'}, {'id': 'FG001', 'title': 'Part 2: Acthar Gel', 'description': 'Participants receive 1 mL Acthar Gel twice weekly during Part 2, from Week 12 through Week 24'}, {'id': 'FG002', 'title': 'Part 2: Placebo', 'description': 'Participants receive 1 mL placebo twice weekly during Part 2, from Week 12 through Week 24'}], 'periods': [{'title': 'Part 1: Open Label', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'comment': 'Part 2 Blinded groups were not evaluated as such during Part 1', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'mITT Population', 'comment': 'All participants who received study drug and contributed efficacy data.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Safety Population', 'comment': 'All participants who received study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Per Protocol Population', 'comment': 'All participants who completed the Part 1 of the study without major protocol deviation.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Met withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Did Not Achieve Lda At Week 12', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Dose Greater Than 20mg/Week', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'did not meet inclusion criteria 8', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Termination by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Double-blind', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '154 of the original Part 1 participants continued to Part 2, randomized to Acthar or placebo', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '77 participants who completed Part 1 were to receive Acthar for an additional 12 weeks in Part 2', 'groupId': 'FG001', 'numSubjects': '77'}, {'comment': '77 participants who completed Part 1 were to receive placebo for an additional 12 weeks in Part 2', 'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'mITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': 'Per Protocol Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Met withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Worsening of disease activity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Did not meet LDA at Week 16', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Did not meet LDA at Week 20', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Discontinued exclusion 16', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 259 patients were recruited at 80 study centers globally for Part 1. Of those participants, 77 were randomized to receive Acthar and 77 were randomized to receive Placebo for an additional 12 weeks, which was Part 2.', 'preAssignmentDetails': 'All participants enrolled in Part 1'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: All Participants Enrolled', 'description': 'All participants who enrolled in the trial'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '231', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '213', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '170', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-04', 'size': 981003, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-06T11:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Part 1: Open Label ; Part 2: Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part 1: Single Group; Part 2: Parallel'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2016-09-26', 'resultsFirstSubmitDate': '2020-03-06', 'studyFirstSubmitQcDate': '2016-09-28', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-06', 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants With Low Disease Activity (LDA) by Visit', 'timeFrame': 'Baseline to Week 12', 'description': 'LDA is defined as DAS28 \\<3.2.'}, {'measure': 'Part 2: Number of Participants Who Maintained Low Disease Activity by Visit', 'timeFrame': 'Week 12 to Week 24', 'description': 'Low disease activity is defined as DAS28 \\<3.2.'}], 'secondaryOutcomes': [{'measure': 'Part 1: Swollen Joint Count by Visit', 'timeFrame': 'Baseline to Week 12', 'description': "The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)\n\nThe DAS28 is a composite score derived from the following assessments:\n\n* Swollen Joint Count\n* Tender Joint Count\n* Patient's Global Health\n* Erythrocyte Sedimentation Rate"}, {'measure': 'Part 2: Swollen Joint Count by Visit During Part 2', 'timeFrame': 'Baseline, Week 12 to Week 24', 'description': "The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR/DAS28)\n\nThe DAS28 is a composite score derived from the following assessments:\n\n* Swollen Joint Count\n* Tender Joint Count\n* Patient's Global Health\n* Erythrocyte Sedimentation Rate"}, {'measure': 'Part 1: Tender Joint Count by Visit', 'timeFrame': 'Baseline to Week 12', 'description': "The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)\n\nThe DAS28 is a composite score derived from the following assessments:\n\n* Swollen Joint Count\n* Tender Joint Count\n* Patient's Global Health\n* Erythrocyte Sedimentation Rate"}, {'measure': 'Part 2: Tender Joint Count by Visit', 'timeFrame': 'Baseline, Week 12 to Week 24', 'description': "The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)\n\nThe DAS28 is a composite score derived from the following assessments:\n\n* Swollen Joint Count\n* Tender Joint Count\n* Patient's Global Health\n* Erythrocyte Sedimentation Rate"}, {'measure': 'Part 1: Patient-Reported General Health by Visit', 'timeFrame': 'Baseline to Week 12', 'description': 'Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.\n\nA lower score indicates better general health.'}, {'measure': 'Part 2: Patient-Reported General Health by Visit', 'timeFrame': 'Baseline, Week 12 to Week 24', 'description': 'Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.\n\nA lower score indicates better general health.'}, {'measure': 'Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit', 'timeFrame': 'Baseline to Week 12', 'description': "The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.\n\nThe clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).\n\nThe normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.\n\nThe ESR is a common test for inflammation and used to derive the DAS28.\n\nThe DAS28 is a composite score derived from the following assessments:\n\n* Swollen Joint Count\n* Tender Joint Count\n* Patient's Global Health\n* Erythrocyte Sedimentation Rate"}, {'measure': 'Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit', 'timeFrame': 'Baseline, Week 12 to Week 24', 'description': "The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.\n\nThe clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).\n\nThe normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.\n\nThe ESR is a common test for inflammation and used to derive the DAS28.\n\nThe DAS28 is a composite score derived from the following assessments:\n\n* Swollen Joint Count\n* Tender Joint Count\n* Patient's Global Health\n* Erythrocyte Sedimentation Rate"}, {'measure': "Part 1: Patient's Global Assessment of Pain by Visit", 'timeFrame': 'Baseline to Week 12', 'description': 'Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.'}, {'measure': "Part 2: Patient's Global Assessment of Pain by Visit", 'timeFrame': 'Baseline, Week 12 to Week 24', 'description': 'Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.'}, {'measure': "Part 1: Physician's Global Assessment of Disease Activities by Visit", 'timeFrame': 'Baseline to Week 12', 'description': "The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement."}, {'measure': "Part 2: Physician's Global Assessment of Disease Activities by Visit", 'timeFrame': 'Week 12 to Week 24', 'description': "The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Persistent disease activity'], 'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'references': [{'pmid': '32497440', 'type': 'DERIVED', 'citation': 'Fleischmann R, Furst DE. Safety of repository corticotropin injection as an adjunctive therapy for the treatment of rheumatoid arthritis. Expert Opin Drug Saf. 2020 Aug;19(8):935-944. doi: 10.1080/14740338.2020.1779219. Epub 2020 Jun 16.'}, {'pmid': '32185745', 'type': 'DERIVED', 'citation': 'Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial. Rheumatol Ther. 2020 Jun;7(2):327-344. doi: 10.1007/s40744-020-00199-3. Epub 2020 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease.\n\nPart 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR.\n\nParticipants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks.\n\nA single participant might be involved in the trial for as many as 32 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or nonpregnant, nonlactating female subjects\n* Meets criteria for definite rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening\n* Has active disease defined as a score of \\>3.2 on DAS28-ESR prior to study drug administration despite dual-DMARD treatment\n* Is on a stable dose of ≤ 20 mg per week of methotrexate for at least 8 weeks AND a stable dose of an allowed DMARD for at least 24 weeks prior to the screening visit\n* May also be on a stable dose of 10 mg or less of prednisone or other the dose equivalent of another corticosteroid for 4 weeks prior to study drug administration\n\nExclusion Criteria:\n\n* Has current rheumatoid disease or inflammatory joint disease other than RA\n* Has any history of use of adrenocorticotropic hormone (ACTH) for the treatment of RA\n* Has taken B-cell mediated therapies in the 6 months prior to screening\n* Has hepatitis B, hepatitis C, history of tuberculosis (TB) or other contraindication as per the United States (US) Prescribing Information for Acthar\n* Has history of Type 1 or Type 2 diabetes\n* Has any clinically significant infection'}, 'identificationModule': {'nctId': 'NCT02919761', 'briefTitle': 'Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment', 'orgStudyIdInfo': {'id': 'MNK14294063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: All Enrolled Participants', 'description': 'All participants receive Acthar Gel 1 mL twice weekly for 12 weeks', 'interventionNames': ['Drug: Acthar Gel']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Acthar Gel', 'description': 'Participants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks', 'interventionNames': ['Drug: Acthar Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2: Placebo', 'description': 'Participants receive Placebo 1 mL twice weekly for an additional 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Acthar Gel', 'type': 'DRUG', 'otherNames': ['Acthar', 'H.P. Acthar Gel'], 'description': '80 Units Acthar Gel per 1 mL for subcutaneous injection', 'armGroupLabels': ['Part 1: All Enrolled Participants', 'Part 2: Acthar Gel']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Matching Placebo'], 'description': 'Matching placebo 1 mL for subcutaneous injection', 'armGroupLabels': ['Part 2: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94578', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Rheumatology Medical Group', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Inland Rheumatology Clinical Trials', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Orthopedic Research Institute', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Southeastern Integrated Medical, PL, d/b/a Florida Medical Research', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Indago Research and Health Center', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33032', 'city': 'Homestead', 'state': 'Florida', 'country': 'United States', 'facility': 'Homestead Associates in Research', 'geoPoint': {'lat': 25.46872, 'lon': -80.47756}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pharmax Research Clinic', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Research Group, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33015', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'San Marcus Research Clinic', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Clinical Research', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '32810', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Omega Research Consultants-DeBary', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Millennium Research', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Arthritis & Rheumatology of Georgia, PC', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Arthritis Research and Treatment Center', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '71203', 'city': 'Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Arthritis and Diabetes Clinic, Inc.', 'geoPoint': {'lat': 32.50931, 'lon': -92.1193}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'June DO, PC', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Physician Research Collaboration, LLC', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'DJL Clinical Research', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '29204', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Columbia Arthritis Center', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'West Tennessee Research Institute', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Ramesh C. 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