Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT02980692
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2016-11-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of SUNPG1623
Sponsor:
Organization:
Raw JSON
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SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 18, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Part 1 : SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 16, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Part 1 : SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 22, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part 1 : Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 18, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Part 2: SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 14, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 2 : SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 11, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 2 : SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 6, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part 2: Week 24 - 48: SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 18, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG009', 'title': 'Part 2: Week 24 - 48: Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 9, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Part 3: SUNPG1623 I', 'description': 'Wash-out period', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 8, 'seriousNumAtRisk': 78, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG011', 'title': 'Part 3 : SUNPG1623 II', 'description': 'Wash-out period', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 1, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG012', 'title': 'Part 3 : SUNPG1623 Dose III', 'description': 'Wash-out period', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 3, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG013', 'title': 'Part 3 :Wash-out Period (SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24)', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nPart 2 : Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48\n\nPart 3 : wash-out period', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 8, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG014', 'title': 'Part 3 : Wash-out Period (Placebo Moved to SUNPG1623 II After Week 24)', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nPart 2 : Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48\n\nPart 3 : wash-out period', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 8, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 78, 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2}, {'groupId': 'EG011', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 78, 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{'groupId': 'EG011', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 79, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG011', 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0}, {'groupId': 'EG012', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG014', 'numAtRisk': 79, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 79, 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{'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7949', 'groupId': 'OG000'}, {'value': '0.7722', 'groupId': 'OG001'}, {'value': '0.7143', 'groupId': 'OG002'}, {'value': '0.7308', 'groupId': 'OG003'}, {'value': '0.5063', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0006', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0088', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0041', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'week 24', 'description': "The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.\n\nFor 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.", 'unitOfMeasure': 'proportion of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Cochran-Mantel-Haenszel Analysis of ACR20 Response Rate At Week 24 (Missing Response = Non-response) - Primary Analysis (Full Analysis Set)'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9254', 'groupId': 'OG000'}, {'value': '0.8906', 'groupId': 'OG001'}, {'value': '0.8667', 'groupId': 'OG002'}, {'value': '0.8133', 'groupId': 'OG003'}, {'value': '0.8133', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '92.54', 'ciLowerLimit': '86.24', 'ciUpperLimit': '98.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.21', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '89.06', 'ciLowerLimit': '81.42', 'ciUpperLimit': '96.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.90', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '86.67', 'ciLowerLimit': '78.07', 'ciUpperLimit': '95.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.39', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '81.33', 'ciLowerLimit': '72.52', 'ciUpperLimit': '90.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.50', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '81.33', 'ciLowerLimit': '72.52', 'ciUpperLimit': '90.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.50', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'week 52', 'description': "The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.\n\nFor 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.", 'unitOfMeasure': 'proportion of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Achieving American College of Rheumatology50 Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.0253', 'groupId': 'OG001'}, {'value': '0.0130', 'groupId': 'OG002'}, {'value': '0.0128', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0256', 'groupId': 'OG000'}, {'value': '0.0506', 'groupId': 'OG001'}, {'value': '0.0909', 'groupId': 'OG002'}, {'value': '0.0385', 'groupId': 'OG003'}, {'value': '0.0253', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.1667', 'groupId': 'OG000'}, {'value': '0.0759', 'groupId': 'OG001'}, {'value': '0.1299', 'groupId': 'OG002'}, {'value': '0.1410', 'groupId': 'OG003'}, {'value': '0.0759', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.1795', 'groupId': 'OG000'}, {'value': '0.1772', 'groupId': 'OG001'}, {'value': '0.2078', 'groupId': 'OG002'}, {'value': '0.1923', 'groupId': 'OG003'}, {'value': '0.0633', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.3077', 'groupId': 'OG000'}, {'value': '0.2785', 'groupId': 'OG001'}, {'value': '0.2727', 'groupId': 'OG002'}, {'value': '0.2051', 'groupId': 'OG003'}, {'value': '0.0506', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.4487', 'groupId': 'OG000'}, {'value': '0.4177', 'groupId': 'OG001'}, {'value': '0.2857', 'groupId': 'OG002'}, {'value': '0.2308', 'groupId': 'OG003'}, {'value': '0.1646', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.5256', 'groupId': 'OG000'}, {'value': '0.5063', 'groupId': 'OG001'}, {'value': '0.4545', 'groupId': 'OG002'}, {'value': '0.3974', 'groupId': 'OG003'}, {'value': '0.2405', 'groupId': 'OG004'}]}]}, {'title': 'week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.7910', 'groupId': 'OG000'}, {'value': '0.7500', 'groupId': 'OG001'}, {'value': '0.7213', 'groupId': 'OG002'}, {'value': '0.6800', 'groupId': 'OG003'}, {'value': '0.6267', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '79.10', 'ciLowerLimit': '69.37', 'ciUpperLimit': '88.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.97', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '75.00', 'ciLowerLimit': '64.39', 'ciUpperLimit': '85.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.41', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '72.13', 'ciLowerLimit': '60.88', 'ciUpperLimit': '83.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.74', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.00', 'ciLowerLimit': '57.44', 'ciUpperLimit': '78.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.39', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '62.67', 'ciLowerLimit': '51.72', 'ciUpperLimit': '73.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.59', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52', 'description': "The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.\n\nFor 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.", 'unitOfMeasure': 'proportion of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Cochran-Mantel-Haenszel Analysis of ACR50 Response Rates up to Week 24 Full Analysis Set.\n\nACR50 Response Rates up to Week 52 Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Achieving American College of Rheumatology70 Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.0127', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0128', 'groupId': 'OG000'}, {'value': '0.0127', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0.0128', 'groupId': 'OG003'}, {'value': '0.0127', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0256', 'groupId': 'OG000'}, {'value': '0.0380', 'groupId': 'OG001'}, {'value': '0.0260', 'groupId': 'OG002'}, {'value': '0.0256', 'groupId': 'OG003'}, {'value': '0.0380', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.1026', 'groupId': 'OG000'}, {'value': '0.0380', 'groupId': 'OG001'}, {'value': '0.0649', 'groupId': 'OG002'}, {'value': '0.1026', 'groupId': 'OG003'}, {'value': '0.0127', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.1410', 'groupId': 'OG000'}, {'value': '0.1266', 'groupId': 'OG001'}, {'value': '0.1169', 'groupId': 'OG002'}, {'value': '0.0897', 'groupId': 'OG003'}, {'value': '0.0253', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.2051', 'groupId': 'OG000'}, {'value': '0.2658', 'groupId': 'OG001'}, {'value': '0.1429', 'groupId': 'OG002'}, {'value': '0.1282', 'groupId': 'OG003'}, {'value': '0.0380', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.2821', 'groupId': 'OG000'}, {'value': '0.2911', 'groupId': 'OG001'}, {'value': '0.2208', 'groupId': 'OG002'}, {'value': '0.1667', 'groupId': 'OG003'}, {'value': '0.1013', 'groupId': 'OG004'}]}]}, {'title': 'week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.5821', 'groupId': 'OG000'}, {'value': '0.4844', 'groupId': 'OG001'}, {'value': '0.3934', 'groupId': 'OG002'}, {'value': '0.4000', 'groupId': 'OG003'}, {'value': '0.3733', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '58.21', 'ciLowerLimit': '46.40', 'ciUpperLimit': '70.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.03', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48.44', 'ciLowerLimit': '36.19', 'ciUpperLimit': '60.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.25', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.34', 'ciLowerLimit': '27.09', 'ciUpperLimit': '51.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.25', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.00', 'ciLowerLimit': '28.91', 'ciUpperLimit': '51.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.66', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.33', 'ciLowerLimit': '26.39', 'ciUpperLimit': '48.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.59', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52', 'description': "The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.\n\nFor 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.", 'unitOfMeasure': 'proportion of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Cochran-Mantel-Haenszel Analysis of ACR70 Response Rates up to Week 24 Full Analysis Set ACR70 Response Rates up to Week 52 Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '0.78', 'groupId': 'OG002'}, {'value': '-3.1', 'spread': '0.76', 'groupId': 'OG003'}, {'value': '-2.1', 'spread': '0.76', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-4.7', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '0.89', 'groupId': 'OG002'}, {'value': '-3.9', 'spread': '0.88', 'groupId': 'OG003'}, {'value': '-4.1', 'spread': '0.87', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-7.1', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '-8.6', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '-7.2', 'spread': '0.93', 'groupId': 'OG003'}, {'value': '-6.9', 'spread': '0.91', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-8.3', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '-8.7', 'spread': '0.95', 'groupId': 'OG002'}, {'value': '-7.8', 'spread': '0.96', 'groupId': 'OG003'}, {'value': '-7.7', 'spread': '0.94', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-10.3', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-11.3', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '-10.7', 'spread': '1.03', 'groupId': 'OG002'}, {'value': '-9.8', 'spread': '1.04', 'groupId': 'OG003'}, {'value': '-8.4', 'spread': '1.02', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-11.2', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '-11.5', 'spread': '1.07', 'groupId': 'OG002'}, {'value': '-11.4', 'spread': '1.09', 'groupId': 'OG003'}, {'value': '-9.9', 'spread': '1.06', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-11.9', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-12.6', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '-12.9', 'spread': '1.03', 'groupId': 'OG002'}, {'value': '-12.0', 'spread': '1.04', 'groupId': 'OG003'}, {'value': '-9.4', 'spread': '1.02', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0850', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0234', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0140', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0731', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': 'Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.', 'unitOfMeasure': 'tender joint counts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.3', 'spread': '11.47', 'groupId': 'OG000'}, {'value': '-13.7', 'spread': '11.92', 'groupId': 'OG001'}, {'value': '-16.0', 'spread': '12.83', 'groupId': 'OG002'}, {'value': '-14.0', 'spread': '10.65', 'groupId': 'OG003'}, {'value': '-13.9', 'spread': '12.02', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-12.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.47', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-13.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.92', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-16.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.83', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-14.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '10.65', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-13.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.02', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.', 'unitOfMeasure': 'tender joint counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Swollen Joint Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '0.52', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '0.51', 'groupId': 'OG003'}, {'value': '-1.3', 'spread': '0.51', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '0.55', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '0.55', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-5.8', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '0.55', 'groupId': 'OG002'}, {'value': '-5.0', 'spread': '0.55', 'groupId': 'OG003'}, {'value': '-4.7', 'spread': '0.54', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-7.3', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '0.55', 'groupId': 'OG002'}, {'value': '-4.8', 'spread': '0.55', 'groupId': 'OG003'}, {'value': '-4.9', 'spread': '0.54', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-8.0', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '-7.0', 'spread': '0.55', 'groupId': 'OG002'}, {'value': '-6.0', 'spread': '0.56', 'groupId': 'OG003'}, {'value': '-5.2', 'spread': '0.55', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-8.3', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '-7.4', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '-6.8', 'spread': '0.56', 'groupId': 'OG003'}, {'value': '-6.0', 'spread': '0.55', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-8.3', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '-8.2', 'spread': '0.52', 'groupId': 'OG002'}, {'value': '-7.6', 'spread': '0.52', 'groupId': 'OG003'}, {'value': '-6.5', 'spread': '0.51', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0111', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0774', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0190', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1282', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': 'Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.', 'unitOfMeasure': 'Swollen Joint Counts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in Swollen Joint Counts up to Week 24 - (No Imputation) Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Swollen Joint Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.7', 'spread': '6.88', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '7.07', 'groupId': 'OG001'}, {'value': '-9.2', 'spread': '7.62', 'groupId': 'OG002'}, {'value': '-7.5', 'spread': '5.78', 'groupId': 'OG003'}, {'value': '-9.0', 'spread': '8.80', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-8.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.88', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-7.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.07', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-9.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.62', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-7.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.78', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-9.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '8.80', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.', 'unitOfMeasure': 'Swollen Joint Counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Physician Global Assessment of Disease Activity Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-7.8', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '-7.2', 'spread': '1.70', 'groupId': 'OG002'}, {'value': '-6.2', 'spread': '1.68', 'groupId': 'OG003'}, {'value': '-4.5', 'spread': '1.67', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-14.3', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-15.7', 'spread': '1.99', 'groupId': 'OG001'}, {'value': '-15.1', 'spread': '1.99', 'groupId': 'OG002'}, {'value': '-14.0', 'spread': '1.99', 'groupId': 'OG003'}, {'value': '-9.7', 'spread': '1.95', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-21.9', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '-23.6', 'spread': '2.16', 'groupId': 'OG001'}, {'value': '-23.9', 'spread': '2.18', 'groupId': 'OG002'}, {'value': '-20.8', 'spread': '2.18', 'groupId': 'OG003'}, {'value': '-16.2', 'spread': '2.13', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-27.9', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '-28.7', 'spread': '2.17', 'groupId': 'OG001'}, {'value': '-27.6', 'spread': '2.19', 'groupId': 'OG002'}, {'value': '-23.1', 'spread': '2.22', 'groupId': 'OG003'}, {'value': '-18.5', 'spread': '2.17', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-31.0', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '-32.1', 'spread': '2.03', 'groupId': 'OG001'}, {'value': '-31.7', 'spread': '2.05', 'groupId': 'OG002'}, {'value': '-30.8', 'spread': '2.08', 'groupId': 'OG003'}, {'value': '-20.2', 'spread': '2.04', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-36.7', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '-36.8', 'spread': '2.13', 'groupId': 'OG001'}, {'value': '-31.0', 'spread': '2.15', 'groupId': 'OG002'}, {'value': '-33.0', 'spread': '2.19', 'groupId': 'OG003'}, {'value': '-24.3', 'spread': '2.13', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-36.5', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-38.8', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '-37.5', 'spread': '2.11', 'groupId': 'OG002'}, {'value': '-36.3', 'spread': '2.14', 'groupId': 'OG003'}, {'value': '-23.5', 'spread': '2.09', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': '100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)', 'unitOfMeasure': 'scores on a visual analog scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.0', 'spread': '17.38', 'groupId': 'OG000'}, {'value': '-44.3', 'spread': '19.73', 'groupId': 'OG001'}, {'value': '-45.3', 'spread': '19.84', 'groupId': 'OG002'}, {'value': '-42.7', 'spread': '19.18', 'groupId': 'OG003'}, {'value': '-42.0', 'spread': '20.41', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-40.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '17.38', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-44.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19.73', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-45.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19.84', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-42.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19.18', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-42.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '20.41', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': '100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)', 'unitOfMeasure': 'scores on a visual analog scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': "Patient's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-5.9', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '1.84', 'groupId': 'OG001'}, {'value': '-6.8', 'spread': '1.87', 'groupId': 'OG002'}, {'value': '-6.4', 'spread': '1.84', 'groupId': 'OG003'}, {'value': '-2.8', 'spread': '1.84', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-7.5', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '-11.9', 'spread': '2.14', 'groupId': 'OG001'}, {'value': '-9.5', 'spread': '2.15', 'groupId': 'OG002'}, {'value': '-8.8', 'spread': '2.14', 'groupId': 'OG003'}, {'value': '-5.9', 'spread': '2.11', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-15.4', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '-15.5', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '-14.5', 'spread': '2.28', 'groupId': 'OG002'}, {'value': '-13.1', 'spread': '2.28', 'groupId': 'OG003'}, {'value': '-10.1', 'spread': '2.23', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-18.1', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '-20.3', 'spread': '2.46', 'groupId': 'OG001'}, {'value': '-16.1', 'spread': '2.49', 'groupId': 'OG002'}, {'value': '-16.4', 'spread': '2.51', 'groupId': 'OG003'}, {'value': '-11.2', 'spread': '2.46', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-23.5', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '-22.0', 'spread': '2.57', 'groupId': 'OG001'}, {'value': '-18.7', 'spread': '2.59', 'groupId': 'OG002'}, {'value': '-19.4', 'spread': '2.63', 'groupId': 'OG003'}, {'value': '-13.8', 'spread': '2.58', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-29.7', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '-27.3', 'spread': '2.57', 'groupId': 'OG001'}, {'value': '-22.7', 'spread': '2.60', 'groupId': 'OG002'}, {'value': '-21.6', 'spread': '2.64', 'groupId': 'OG003'}, {'value': '-15.6', 'spread': '2.58', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-35.0', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-33.3', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '-33.4', 'spread': '2.56', 'groupId': 'OG002'}, {'value': '-30.4', 'spread': '2.60', 'groupId': 'OG003'}, {'value': '-21.7', 'spread': '2.54', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0012', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0011', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0167', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20 and week 24', 'description': '100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)', 'unitOfMeasure': 'scores on a visual analog scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV 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'groupId': 'OG003'}, {'value': '-40.5', 'spread': '28.13', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-42.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '22.74', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-43.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '24.01', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-38.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '27.90', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-37.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '24.65', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-40.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '28.13', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': '100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)', 'unitOfMeasure': 'scores on a visual analog scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': "Patient's Pain Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-5.8', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-8.1', 'spread': '1.95', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '1.98', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '1.95', 'groupId': 'OG003'}, {'value': '-1.6', 'spread': '1.95', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-9.8', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-12.8', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '-8.9', 'spread': '2.13', 'groupId': 'OG002'}, {'value': '-6.4', 'spread': '2.12', 'groupId': 'OG003'}, {'value': '-3.9', 'spread': '2.09', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-16.9', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-16.1', 'spread': '2.37', 'groupId': 'OG001'}, {'value': '-16.6', 'spread': '2.41', 'groupId': 'OG002'}, {'value': '-11.9', 'spread': '2.40', 'groupId': 'OG003'}, {'value': '-8.5', 'spread': '2.35', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-19.4', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '-20.4', 'spread': '2.48', 'groupId': 'OG001'}, {'value': '-15.6', 'spread': '2.50', 'groupId': 'OG002'}, {'value': '-14.0', 'spread': '2.53', 'groupId': 'OG003'}, {'value': '-11.5', 'spread': '2.48', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-23.8', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '-23.2', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '-20.6', 'spread': '2.55', 'groupId': 'OG002'}, {'value': '-19.3', 'spread': '2.59', 'groupId': 'OG003'}, {'value': '-12.8', 'spread': '2.54', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-29.8', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '-25.3', 'spread': '2.71', 'groupId': 'OG001'}, {'value': '-21.4', 'spread': '2.74', 'groupId': 'OG002'}, {'value': '-21.4', 'spread': '2.78', 'groupId': 'OG003'}, {'value': '-17.1', 'spread': '2.72', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-35.1', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '-31.6', 'spread': '2.60', 'groupId': 'OG001'}, {'value': '-32.1', 'spread': '2.64', 'groupId': 'OG002'}, {'value': '-28.8', 'spread': '2.68', 'groupId': 'OG003'}, {'value': '-21.5', 'spread': '2.63', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0055', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0039', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0487', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': '100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).', 'unitOfMeasure': 'scores on a visual analog scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in Patient's Pain Assessment up to Week 24 - (No Imputation) Full Analysis Set"}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Pain Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.7', 'spread': '21.59', 'groupId': 'OG000'}, {'value': '-42.7', 'spread': '25.67', 'groupId': 'OG001'}, {'value': '-38.0', 'spread': '29.26', 'groupId': 'OG002'}, {'value': '-37.6', 'spread': '26.63', 'groupId': 'OG003'}, {'value': '-41.0', 'spread': '29.83', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-40.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '21.59', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-42.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '25.67', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-38.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29.26', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-37.6', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '26.63', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-41.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29.83', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': '100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).', 'unitOfMeasure': 'scores on a visual analog scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire- Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.0374', 'spread': '0.03454', 'groupId': 'OG000'}, {'value': '-0.0453', 'spread': '0.03436', 'groupId': 'OG001'}, {'value': '-0.0552', 'spread': '0.03492', 'groupId': 'OG002'}, {'value': '-0.0411', 'spread': '0.03435', 'groupId': 'OG003'}, {'value': '-0.0045', 'spread': '0.03439', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.0025', 'spread': '0.04036', 'groupId': 'OG000'}, {'value': '-0.0736', 'spread': '0.03984', 'groupId': 'OG001'}, {'value': '-0.0906', 'spread': '0.03999', 'groupId': 'OG002'}, {'value': '-0.0409', 'spread': '0.03989', 'groupId': 'OG003'}, {'value': '-0.0404', 'spread': '0.03928', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.1510', 'spread': '0.04709', 'groupId': 'OG000'}, {'value': '-0.1279', 'spread': '0.04627', 'groupId': 'OG001'}, {'value': '-0.2035', 'spread': '0.04687', 'groupId': 'OG002'}, {'value': '-0.1041', 'spread': '0.04669', 'groupId': 'OG003'}, {'value': '-0.1265', 'spread': '0.04588', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.1310', 'spread': '0.04601', 'groupId': 'OG000'}, {'value': '-0.2140', 'spread': '0.04507', 'groupId': 'OG001'}, {'value': '-0.2090', 'spread': '0.04555', 'groupId': 'OG002'}, {'value': '-0.1731', 'spread': '0.04597', 'groupId': 'OG003'}, {'value': '-0.1374', 'spread': '0.04503', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-0.2061', 'spread': '0.04890', 'groupId': 'OG000'}, {'value': '-0.2448', 'spread': '0.04790', 'groupId': 'OG001'}, {'value': '-0.2343', 'spread': '0.04843', 'groupId': 'OG002'}, {'value': '-0.2102', 'spread': '0.04889', 'groupId': 'OG003'}, {'value': '-0.1580', 'spread': '0.04801', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-0.3052', 'spread': '0.05256', 'groupId': 'OG000'}, {'value': '-0.2868', 'spread': '0.05128', 'groupId': 'OG001'}, {'value': '-0.2911', 'spread': '0.05185', 'groupId': 'OG002'}, {'value': '-0.1947', 'spread': '0.05244', 'groupId': 'OG003'}, {'value': '-0.2271', 'spread': '0.05135', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.3013', 'spread': '0.05196', 'groupId': 'OG000'}, {'value': '-0.3314', 'spread': '0.05054', 'groupId': 'OG001'}, {'value': '-0.3337', 'spread': '0.05128', 'groupId': 'OG002'}, {'value': '-0.2376', 'spread': '0.05187', 'groupId': 'OG003'}, {'value': '-0.1827', 'spread': '0.05102', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0987', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0360', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0346', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4442', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': 'eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).\n\nThe score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability', 'unitOfMeasure': 'score for the disability index', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire- Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks.\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4869', 'spread': '0.52093', 'groupId': 'OG000'}, {'value': '-0.5430', 'spread': '0.59145', 'groupId': 'OG001'}, {'value': '-0.4857', 'spread': '0.56968', 'groupId': 'OG002'}, {'value': '-0.4583', 'spread': '0.52285', 'groupId': 'OG003'}, {'value': '-0.4700', 'spread': '0.54013', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.4869', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.52093', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.5430', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.59145', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.4857', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.56968', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.4583', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.52285', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.4700', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.54013', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).\n\nThe score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability', 'unitOfMeasure': 'score for the disability index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Acute Phase C - Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.967', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '0.961', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '0.979', 'groupId': 'OG002'}, {'value': '2.08', 'spread': '0.961', 'groupId': 'OG003'}, {'value': '0.51', 'spread': '0.964', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '1.239', 'groupId': 'OG000'}, {'value': '-3.41', 'spread': '1.227', 'groupId': 'OG001'}, {'value': '-0.82', 'spread': '1.223', 'groupId': 'OG002'}, {'value': '0.64', 'spread': '1.222', 'groupId': 'OG003'}, {'value': '-0.28', 'spread': '1.206', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-2.96', 'spread': '1.506', 'groupId': 'OG000'}, {'value': '-3.21', 'spread': '1.476', 'groupId': 'OG001'}, {'value': '-1.54', 'spread': '1.502', 'groupId': 'OG002'}, {'value': '1.95', 'spread': '1.495', 'groupId': 'OG003'}, {'value': '1.24', 'spread': '1.465', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-2.21', 'spread': '1.121', 'groupId': 'OG000'}, {'value': '-3.04', 'spread': '1.097', 'groupId': 'OG001'}, {'value': '-2.59', 'spread': '1.104', 'groupId': 'OG002'}, {'value': '0.11', 'spread': '1.124', 'groupId': 'OG003'}, {'value': '1.49', 'spread': '1.097', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-3.37', 'spread': '1.505', 'groupId': 'OG000'}, {'value': '-3.57', 'spread': '1.462', 'groupId': 'OG001'}, {'value': '-1.67', 'spread': '1.485', 'groupId': 'OG002'}, {'value': '-1.58', 'spread': '1.505', 'groupId': 'OG003'}, {'value': '2.25', 'spread': '1.474', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-3.72', 'spread': '1.708', 'groupId': 'OG000'}, {'value': '-2.76', 'spread': '1.656', 'groupId': 'OG001'}, {'value': '-2.57', 'spread': '1.677', 'groupId': 'OG002'}, {'value': '-0.61', 'spread': '1.715', 'groupId': 'OG003'}, {'value': '4.60', 'spread': '1.672', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-3.56', 'spread': '1.088', 'groupId': 'OG000'}, {'value': '-2.33', 'spread': '1.054', 'groupId': 'OG001'}, {'value': '-3.23', 'spread': '1.071', 'groupId': 'OG002'}, {'value': '-2.06', 'spread': '1.088', 'groupId': 'OG003'}, {'value': '0.55', 'spread': '1.065', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0064', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0516', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0114', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0820', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': 'C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.\n\nCRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in CRP (mg/L) up to Week 24 - (No Imputation) Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Acute Phase C - Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.43', 'spread': '12.506', 'groupId': 'OG000'}, {'value': '-3.68', 'spread': '10.770', 'groupId': 'OG001'}, {'value': '-6.05', 'spread': '19.004', 'groupId': 'OG002'}, {'value': '-4.61', 'spread': '9.508', 'groupId': 'OG003'}, {'value': '-6.75', 'spread': '19.649', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.43', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.506', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.68', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '10.770', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-6.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19.004', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4.61', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '9.508', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-6.75', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19.649', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.\n\nCRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation.\n\nChange from Baseline in C-Reactive Protein.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Erythrocyte Sedimentation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '-1.1', 'spread': '1.41', 'groupId': 'OG003'}, {'value': '-2.6', 'spread': '1.45', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-6.9', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '1.48', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '-5.6', 'spread': '1.47', 'groupId': 'OG003'}, {'value': '-4.8', 'spread': '1.51', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-8.7', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '1.58', 'groupId': 'OG001'}, {'value': '-7.1', 'spread': '1.58', 'groupId': 'OG002'}, {'value': '-5.5', 'spread': '1.60', 'groupId': 'OG003'}, {'value': '-3.6', 'spread': '1.64', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-8.6', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '1.59', 'groupId': 'OG001'}, {'value': '-7.9', 'spread': '1.58', 'groupId': 'OG002'}, {'value': '-6.6', 'spread': '1.62', 'groupId': 'OG003'}, {'value': '-2.3', 'spread': '1.66', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-9.4', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '1.92', 'groupId': 'OG001'}, {'value': '-8.3', 'spread': '1.91', 'groupId': 'OG002'}, {'value': '-6.0', 'spread': '1.96', 'groupId': 'OG003'}, {'value': '-3.3', 'spread': '2.02', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-9.6', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '-9.2', 'spread': '1.71', 'groupId': 'OG002'}, {'value': '-8.5', 'spread': '1.76', 'groupId': 'OG003'}, {'value': '-4.4', 'spread': '1.81', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-8.0', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '1.85', 'groupId': 'OG001'}, {'value': '-8.2', 'spread': '1.84', 'groupId': 'OG002'}, {'value': '-8.7', 'spread': '1.89', 'groupId': 'OG003'}, {'value': '-2.3', 'spread': '1.95', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0351', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0876', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0269', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0185', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': 'An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in ESR (mm/hr) up to Week 24 - (No Imputation) Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Sedimentation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.2', 'spread': '19.58', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '15.26', 'groupId': 'OG001'}, {'value': '-8.9', 'spread': '20.48', 'groupId': 'OG002'}, {'value': '-9.7', 'spread': '19.02', 'groupId': 'OG003'}, {'value': '-9.2', 'spread': '20.47', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-7.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19.58', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-7.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '15.26', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-8.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '20.48', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-9.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '19.02', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-9.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '20.47', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'The Proportion of Subjects Who Require Adjustment of Background Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.0127', 'groupId': 'OG001'}, {'value': '0.0130', 'groupId': 'OG002'}, {'value': '0.0256', 'groupId': 'OG003'}, {'value': '0.0127', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Proportion with Adjustment of Background', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.00', 'ciUpperLimit': '3.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.26', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Proportion with Adjustment of Background', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.00', 'ciUpperLimit': '3.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.29', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Proportion with Adjustment of Background', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.56', 'ciLowerLimit': '0.00', 'ciUpperLimit': '6.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.79', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Proportion with Adjustment of Background', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.00', 'ciUpperLimit': '3.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.26', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'unitOfMeasure': 'proportion of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects Who Require Adjustment of Background Therapy at Week 16 Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.54', 'groupId': 'OG000'}, {'value': '12.66', 'groupId': 'OG001'}, {'value': '10.39', 'groupId': 'OG002'}, {'value': '5.13', 'groupId': 'OG003'}, {'value': '6.33', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.51', 'groupId': 'OG000'}, {'value': '17.72', 'groupId': 'OG001'}, {'value': '15.58', 'groupId': 'OG002'}, {'value': '15.38', 'groupId': 'OG003'}, {'value': '13.92', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '35.90', 'groupId': 'OG000'}, {'value': '29.11', 'groupId': 'OG001'}, {'value': '29.87', 'groupId': 'OG002'}, {'value': '23.08', 'groupId': 'OG003'}, {'value': '18.99', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '38.46', 'groupId': 'OG000'}, {'value': '40.51', 'groupId': 'OG001'}, {'value': '31.17', 'groupId': 'OG002'}, {'value': '29.49', 'groupId': 'OG003'}, {'value': '18.99', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '48.72', 'groupId': 'OG000'}, {'value': '48.10', 'groupId': 'OG001'}, {'value': '36.36', 'groupId': 'OG002'}, {'value': '35.90', 'groupId': 'OG003'}, {'value': '13.92', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '60.26', 'groupId': 'OG000'}, {'value': '60.76', 'groupId': 'OG001'}, {'value': '37.66', 'groupId': 'OG002'}, {'value': '43.59', 'groupId': 'OG003'}, {'value': '21.52', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '58.97', 'groupId': 'OG000'}, {'value': '64.56', 'groupId': 'OG001'}, {'value': '58.44', 'groupId': 'OG002'}, {'value': '53.85', 'groupId': 'OG003'}, {'value': '30.38', 'groupId': 'OG004'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '85.07', 'groupId': 'OG000'}, {'value': '81.25', 'groupId': 'OG001'}, {'value': '76.27', 'groupId': 'OG002'}, {'value': '71.05', 'groupId': 'OG003'}, {'value': '65.33', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '85.07', 'ciLowerLimit': '76.54', 'ciUpperLimit': '93.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.35', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '81.25', 'ciLowerLimit': '71.69', 'ciUpperLimit': '90.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.88', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '76.27', 'ciLowerLimit': '65.42', 'ciUpperLimit': '87.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.54', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.05', 'ciLowerLimit': '60.86', 'ciUpperLimit': '81.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.33', 'ciLowerLimit': '54.56', 'ciUpperLimit': '76.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.50', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, week 24 and Week 52', 'description': 'The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP).\n\nDAS28-CRP(4) = 0.56\\*sqrt(TJC28) + 0.28\\*sqrt(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cochran-Mantel-Haenszel Analysis of DAS28-CRP Response Rates up to Week 24 Full Analysis Set.\n\nDAS28-CRP Response Rates up to Week 52-Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Minimal Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.85', 'groupId': 'OG000'}, {'value': '1.27', 'groupId': 'OG001'}, {'value': '1.30', 'groupId': 'OG002'}, {'value': '2.56', 'groupId': 'OG003'}, {'value': '1.27', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.85', 'groupId': 'OG000'}, {'value': '2.53', 'groupId': 'OG001'}, {'value': '2.60', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2.53', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.82', 'groupId': 'OG000'}, {'value': '8.86', 'groupId': 'OG001'}, {'value': '7.79', 'groupId': 'OG002'}, {'value': '8.97', 'groupId': 'OG003'}, {'value': '2.53', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.82', 'groupId': 'OG000'}, {'value': '6.33', 'groupId': 'OG001'}, {'value': '7.79', 'groupId': 'OG002'}, {'value': '8.97', 'groupId': 'OG003'}, {'value': '1.27', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17.95', 'groupId': 'OG000'}, {'value': '15.19', 'groupId': 'OG001'}, {'value': '9.09', 'groupId': 'OG002'}, {'value': '8.97', 'groupId': 'OG003'}, {'value': '2.53', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '33.33', 'groupId': 'OG000'}, {'value': '34.18', 'groupId': 'OG001'}, {'value': '28.57', 'groupId': 'OG002'}, {'value': '19.23', 'groupId': 'OG003'}, {'value': '6.33', 'groupId': 'OG004'}]}]}, {'title': 'week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '56.92', 'groupId': 'OG000'}, {'value': '64.41', 'groupId': 'OG001'}, {'value': '45.00', 'groupId': 'OG002'}, {'value': '47.06', 'groupId': 'OG003'}, {'value': '42.03', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '56.92', 'ciLowerLimit': '44.88', 'ciUpperLimit': '68.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.14', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '64.41', 'ciLowerLimit': '52.19', 'ciUpperLimit': '76.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.23', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.00', 'ciLowerLimit': '32.41', 'ciUpperLimit': '57.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.42', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.06', 'ciLowerLimit': '35.20', 'ciUpperLimit': '58.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.05', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': '% response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.03', 'ciLowerLimit': '30.38', 'ciUpperLimit': '53.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.94', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52', 'description': "A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria:\n\n1. tender joint count ≤1;\n2. swollen joint count ≤1;\n3. PASI score ≤1 or BSA ≤3%;\n4. patient Arthritis Pain (VAS)\n\n ≤15 mm;\n5. patient's global arthritis assessment (VAS) ≤20 mm;\n6. HAQ-DI score ≤0.5;\n7. tender entheseal points (using LEI) ≤1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cochran-Mantel-Haenszel Analysis of MDA Response Rates up to Week 24 (Missing Response = Non-response) Full Analysis Set.\n\nMDA Response Rates up to Week 52- Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Leeds Dactylitis Index (LDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-17.385', 'spread': '9.8336', 'groupId': 'OG000'}, {'value': '-17.918', 'spread': '9.5818', 'groupId': 'OG001'}, {'value': '-19.150', 'spread': '10.4630', 'groupId': 'OG002'}, {'value': '-5.385', 'spread': '10.2843', 'groupId': 'OG003'}, {'value': '19.891', 'spread': '9.6640', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-21.041', 'spread': '7.8359', 'groupId': 'OG000'}, {'value': '-23.163', 'spread': '7.5635', 'groupId': 'OG001'}, {'value': '-23.948', 'spread': '8.3579', 'groupId': 'OG002'}, {'value': '-9.982', 'spread': '8.2513', 'groupId': 'OG003'}, {'value': '-2.990', 'spread': '7.7362', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-22.987', 'spread': '3.5112', 'groupId': 'OG000'}, {'value': '-25.123', 'spread': '3.2307', 'groupId': 'OG001'}, {'value': '-27.572', 'spread': '3.5088', 'groupId': 'OG002'}, {'value': '-19.873', 'spread': '3.4520', 'groupId': 'OG003'}, {'value': '-24.706', 'spread': '3.2252', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.7081', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9244', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5365', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2925', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 4, week 12, and week 24', 'description': 'tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)\n\nTotal score= {\\[Circumference involved digit/ Circumference contralateral Digit (or Tables)\\] - 1x 100}x Tenderness score\n\nStandard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45\n\nThe difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.\n\nLower Leeds Dactylitis Index score represent better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in LDI up to Week 24 - (No Imputation) Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Leeds Dactylitis Index (LDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.453', 'spread': '31.9358', 'groupId': 'OG000'}, {'value': '-18.883', 'spread': '57.1147', 'groupId': 'OG001'}, {'value': '-27.084', 'spread': '76.2272', 'groupId': 'OG002'}, {'value': '-26.173', 'spread': '87.5367', 'groupId': 'OG003'}, {'value': '-50.399', 'spread': '141.6770', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-14.453', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '31.9358', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-18.883', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '57.1147', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-27.084', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '76.2272', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-26.173', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '87.5367', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-50.399', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '141.6770', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)\n\nTotal score= {\\[Circumference involved digit/ Circumference contralateral Digit (or Tables)\\] - 1x 100}x Tenderness score\n\nStandard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45\n\nThe difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.\n\nLower Leeds Dactylitis Index score represent better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Leeds Enthesitis Index (LEI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '78', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.14', 'groupId': 'OG003'}, {'value': '-0.4', 'spread': '0.14', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '0.15', 'groupId': 'OG003'}, {'value': '-0.7', 'spread': '0.14', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-1.1', 'spread': '0.15', 'groupId': 'OG003'}, {'value': '-0.8', 'spread': '0.15', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0203', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5194', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0599', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1220', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 4, week 12 and week 24', 'description': 'The LEI examines tenderness at 6 sites:\n\n2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. 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The LEI score range is 0-6.\n\nLower the score better is the outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in LEI up to Week 24 - (No Imputation) Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Leeds Enthesitis Index (LEI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'OG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'OG003', 'title': 'SUNPG1623 Dose IV Moved to SUNPG1623 II After Week 24', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'OG004', 'title': 'Placebo Moved to SUNPG1623 II After Week 24', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks\n\nSubjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '2.08', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '1.75', 'groupId': 'OG003'}, {'value': '-1.2', 'spread': '1.82', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.86', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.56', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.08', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.75', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.82', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'The LEI examines tenderness at 6 sites:\n\n2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. 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'60'}, {'groupId': 'FG003', 'numSubjects': '71'}, {'groupId': 'FG004', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Failure to show sufficient response to treatment at Week 24', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Double-blind Follow-up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '71'}, {'groupId': 'FG004', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '67'}, {'groupId': 'FG004', 'numSubjects': '69'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Failure to show sufficient response to treatment at Week 24', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}, {'value': '391', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'SUNPG1623 I', 'description': 'Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks'}, {'id': 'BG001', 'title': 'SUNPG1623 II', 'description': 'Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'BG002', 'title': 'SUNPG1623 Dose III', 'description': 'Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks'}, {'id': 'BG003', 'title': 'SUNPG1623 Dose IV', 'description': 'Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'spread': '13.28', 'groupId': 'BG000'}, {'value': '49.3', 'spread': '11.24', 'groupId': 'BG001'}, {'value': '49.2', 'spread': '11.85', 'groupId': 'BG002'}, {'value': '47.2', 'spread': '13.35', 'groupId': 'BG003'}, {'value': '48.1', 'spread': '13.30', 'groupId': 'BG004'}, {'value': '48.8', 'spread': '12.61', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '215', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}, {'value': '176', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}, {'value': '332', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}, {'value': '378', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-16', 'size': 1352216, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-09T01:41', 'hasProtocol': True}, {'date': '2019-10-10', 'size': 684349, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-09T01:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 391}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2016-11-30', 'resultsFirstSubmitDate': '2020-10-03', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-18', 'studyFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate', 'timeFrame': 'week 24', 'description': "The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.\n\nFor 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100."}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate', 'timeFrame': 'week 52', 'description': "The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.\n\nFor 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100."}, {'measure': 'Proportion of Subjects Achieving American College of Rheumatology50 Response Rate', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52', 'description': "The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.\n\nFor 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100."}, {'measure': 'Proportion of Subjects Achieving American College of Rheumatology70 Response Rate', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52', 'description': "The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.\n\nFor 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100."}, {'measure': 'Change From Baseline in Tender Joint Counts', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': 'Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.'}, {'measure': 'Change From Baseline in Tender Joint Counts', 'timeFrame': 'Week 52', 'description': 'Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.'}, {'measure': 'Change From Baseline in Swollen Joint Counts', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': 'Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.'}, {'measure': 'Change From Baseline in Swollen Joint Counts', 'timeFrame': 'Week 52', 'description': 'Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.'}, {'measure': 'Physician Global Assessment of Disease Activity Visual Analog Scale', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': '100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)'}, {'measure': 'Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale', 'timeFrame': 'Week 52', 'description': '100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)'}, {'measure': "Patient's Global Assessment of Disease Activity", 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20 and week 24', 'description': '100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)'}, {'measure': "Change From Baseline in Patient's Global Assessment of Disease Activity", 'timeFrame': 'Week 52', 'description': '100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)'}, {'measure': "Patient's Pain Assessment", 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': '100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).'}, {'measure': "Change From Baseline in Patient's Pain Assessment", 'timeFrame': 'Week 52', 'description': '100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).'}, {'measure': 'Health Assessment Questionnaire- Disability Index', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': 'eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).\n\nThe score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability'}, {'measure': 'Change From Baseline in Health Assessment Questionnaire- Disability Index', 'timeFrame': 'Week 52', 'description': 'eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).\n\nThe score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability'}, {'measure': 'Acute Phase C - Reactive Protein', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': 'C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.\n\nCRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation'}, {'measure': 'Acute Phase C - Reactive Protein', 'timeFrame': 'Week 52', 'description': 'C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.\n\nCRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation.\n\nChange from Baseline in C-Reactive Protein.'}, {'measure': 'Erythrocyte Sedimentation Rate', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, and week 24', 'description': 'An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.'}, {'measure': 'Change From Baseline in Erythrocyte Sedimentation Rate', 'timeFrame': 'Week 52', 'description': 'An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.'}, {'measure': 'The Proportion of Subjects Who Require Adjustment of Background Therapy', 'timeFrame': 'Week 16'}, {'measure': 'Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, week 24 and Week 52', 'description': 'The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP).\n\nDAS28-CRP(4) = 0.56\\*sqrt(TJC28) + 0.28\\*sqrt(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health'}, {'measure': 'Minimal Disease Activity', 'timeFrame': 'week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52', 'description': "A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria:\n\n1. tender joint count ≤1;\n2. swollen joint count ≤1;\n3. PASI score ≤1 or BSA ≤3%;\n4. patient Arthritis Pain (VAS)\n\n ≤15 mm;\n5. patient's global arthritis assessment (VAS) ≤20 mm;\n6. HAQ-DI score ≤0.5;\n7. tender entheseal points (using LEI) ≤1."}, {'measure': 'Change From Baseline in Leeds Dactylitis Index (LDI)', 'timeFrame': 'week 4, week 12, and week 24', 'description': 'tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)\n\nTotal score= {\\[Circumference involved digit/ Circumference contralateral Digit (or Tables)\\] - 1x 100}x Tenderness score\n\nStandard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45\n\nThe difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.\n\nLower Leeds Dactylitis Index score represent better outcome.'}, {'measure': 'Change From Baseline in Leeds Dactylitis Index (LDI)', 'timeFrame': 'Week 52', 'description': 'tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)\n\nTotal score= {\\[Circumference involved digit/ Circumference contralateral Digit (or Tables)\\] - 1x 100}x Tenderness score\n\nStandard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45\n\nThe difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.\n\nLower Leeds Dactylitis Index score represent better outcome.'}, {'measure': 'Change From Baseline in Leeds Enthesitis Index (LEI)', 'timeFrame': 'week 4, week 12 and week 24', 'description': 'The LEI examines tenderness at 6 sites:\n\n2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.\n\nLower the score better is the outcome'}, {'measure': 'Change From Baseline in Leeds Enthesitis Index (LEI)', 'timeFrame': 'Week 52', 'description': 'The LEI examines tenderness at 6 sites:\n\n2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.\n\nLower the score better is the outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Active Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '33985942', 'type': 'DERIVED', 'citation': 'Mease PJ, Chohan S, Fructuoso FJG, Luggen ME, Rahman P, Raychaudhuri SP, Chou RC, Mendelsohn AM, Rozzo SJ, Gottlieb A. Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double-blind, placebo-controlled, multiple-dose, 52-week phase IIb study. Ann Rheum Dis. 2021 Sep;80(9):1147-1157. doi: 10.1136/annrheumdis-2020-219014. Epub 2021 May 13.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has provided written informed consent\n* Subject is ≥ 18 years of age at time of Screening\n* Subject must be on stable dose of NSAID for ≥ 4 weeks prior to initiation of IMP\n* Subject has a negative evaluation for TB within 4 weeks before initiating IMP\n* Subject has a diagnosis of PsA (by the Classification of Psoriatic Arthritis \\[CASPAR\\] criteria) with symptoms present for at least 6 months.\n* Subject has ≥ 3 tender and ≥ 3 swollen joints at Screening and Baseline.\n\nExclusion Criteria:\n\n* Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition\n* Subject has an active infection or history of infections\n* Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease\n* Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus'}, 'identificationModule': {'nctId': 'NCT02980692', 'briefTitle': 'Efficacy and Safety Study of SUNPG1623', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries Limited'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Active Psoriatic Arthritis', 'orgStudyIdInfo': {'id': 'CLR_16_23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SUNPG1623 dose I', 'description': 'low range dose', 'interventionNames': ['Drug: SUNPG1623 I']}, {'type': 'EXPERIMENTAL', 'label': 'SUNPG1623 dose II', 'description': 'mid range dose', 'interventionNames': ['Drug: SUNPG1623 II', 'Drug: PLACEBO']}, {'type': 'EXPERIMENTAL', 'label': 'SUNPG1623 dose III', 'description': 'mid range dose', 'interventionNames': ['Drug: SUNPG1623 III', 'Drug: PLACEBO']}, {'type': 'EXPERIMENTAL', 'label': 'SUNPG1623 dose IV', 'description': 'mid range dose to high dose', 'interventionNames': ['Drug: SUNPG1623 IV', 'Drug: PLACEBO']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'mid range dose to high dose', 'interventionNames': ['Drug: PLACEBO']}], 'interventions': [{'name': 'SUNPG1623 I', 'type': 'DRUG', 'description': 'injection', 'armGroupLabels': ['SUNPG1623 dose I']}, {'name': 'SUNPG1623 II', 'type': 'DRUG', 'description': 'injection', 'armGroupLabels': ['SUNPG1623 dose II']}, {'name': 'SUNPG1623 III', 'type': 'DRUG', 'description': 'injection', 'armGroupLabels': ['SUNPG1623 dose III']}, {'name': 'SUNPG1623 IV', 'type': 'DRUG', 'description': 'injection', 'armGroupLabels': ['SUNPG1623 dose IV']}, {'name': 'PLACEBO', 'type': 'DRUG', 'description': 'injection', 'armGroupLabels': ['Placebo', 'SUNPG1623 dose II', 'SUNPG1623 dose III', 'SUNPG1623 dose IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'SPARC Site 1', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}