Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04057118
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2019-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000728456', 'term': 'cevidoplenib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sslee@oscotec.com', 'phone': '+82316287624', 'title': 'Sungsil Lee/Team Leader of Clinical Development', 'organization': 'Oscotec Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'description': 'At every study visit, subjects were asked a standard nonleading question to explore a response regarding any medically related changes in their well-being. They were also asked if they had been hospitalized or had any accidents. In addition to subject observations, AEs identified from any study data (eg, laboratory values, physical examination findings, ECG changes) or identified from review of other documents that were relevant to subject safety were documented.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo: Oral administration, twice per day', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 8, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'SKI-O-703 100 mg', 'description': 'SKI-O-703: Oral administration, twice per day', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 6, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'SKI-O-703 200 mg', 'description': 'SKI-O-703: Oral administration, twice per day', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 10, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'SKI-O-703 400 mg', 'description': 'SKI-O-703: Oral administration, twice per day', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 13, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'seriousEvents': [{'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Disease Activity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Oral administration, twice per day'}, {'id': 'OG001', 'title': 'SKI-O-703 100 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG002', 'title': 'SKI-O-703 200 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG003', 'title': 'SKI-O-703 400 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.95', 'spread': '0.152', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.155', 'groupId': 'OG001'}, {'value': '-1.06', 'spread': '0.155', 'groupId': 'OG002'}, {'value': '-1.15', 'spread': '0.155', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Mean change from baseline in disease activity score for 28 joints (DAS28) using hsCRP (high sensitivity C-reactive protein).\n\nDisease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), and high sensitivity C-reactive protein (hsCRP) (milligrams per liter). DAS28 was calculated using following formula: DAS28-CRP=0.56\\*square root (sqrt)(TJC28)+0.28\\*sqrt(SJC28)+0.36\\*natural log(hsCRP+1)\\*1.10+1.15.\n\nHigh DAS28-hsCRP value indicates more severe disease activity, by value of \\>5.1 indicating relatively high disease activity, whereas value of \\<3.2 indicating achieved lower disease activity (no theoretical full range available).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '• Percentage of Patients With ACR20 (American College of Rheumatology 20) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Oral administration, twice per day'}, {'id': 'OG001', 'title': 'SKI-O-703 100 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG002', 'title': 'SKI-O-703 200 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG003', 'title': 'SKI-O-703 400 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Weeks 2, 4 8 and 12', 'description': "ACR20 score is the percentage of patients showing ≥20% improvement from baseline in tender joint count (68 joint counts), ≥20% improvement in swollen joint count (66 joint counts), and ≥20% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data.'}, {'type': 'SECONDARY', 'title': '• Percentage of Patients With ACR50 (American College of Rheumatology 50) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Oral administration, twice per day'}, {'id': 'OG001', 'title': 'SKI-O-703 100 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG002', 'title': 'SKI-O-703 200 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG003', 'title': 'SKI-O-703 400 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Weeks 2, 4 8 and 12', 'description': "ACR50 score is the percentage of patients showing ≥50% improvement from baseline in tender joint count (68 joint counts), ≥50% improvement in swollen joint count (66 joint counts), and ≥50% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data.'}, {'type': 'SECONDARY', 'title': '• Percentage of Patients With ACR70 (American College of Rheumatology 70) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Oral administration, twice per day'}, {'id': 'OG001', 'title': 'SKI-O-703 100 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG002', 'title': 'SKI-O-703 200 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG003', 'title': 'SKI-O-703 400 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Weeks 2, 4 8 and 12', 'description': "ACR70 score is the percentage of patients showing ≥70% improvement from baseline in tender joint count (68 joint counts), ≥70% improvement in swollen joint count (66 joint counts), and ≥70% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire-Disability Index (HAQ-DI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Oral administration, twice per day'}, {'id': 'OG001', 'title': 'SKI-O-703 100 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG002', 'title': 'SKI-O-703 200 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG003', 'title': 'SKI-O-703 400 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}], 'classes': [{'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.0969', 'spread': '0.3171', 'groupId': 'OG000'}, {'value': '-0.1375', 'spread': '0.2953', 'groupId': 'OG001'}, {'value': '-0.2340', 'spread': '0.3037', 'groupId': 'OG002'}, {'value': '-0.3397', 'spread': '0.4035', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.2179', 'spread': '0.3228', 'groupId': 'OG000'}, {'value': '-0.2906', 'spread': '0.3494', 'groupId': 'OG001'}, {'value': '-0.2895', 'spread': '0.2979', 'groupId': 'OG002'}, {'value': '-0.3718', 'spread': '0.4646', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.3816', 'spread': '0.4171', 'groupId': 'OG000'}, {'value': '-0.3781', 'spread': '0.3968', 'groupId': 'OG001'}, {'value': '-0.3311', 'spread': '0.4362', 'groupId': 'OG002'}, {'value': '-0.4306', 'spread': '0.5040', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.4459', 'spread': '0.4765', 'groupId': 'OG000'}, {'value': '-0.5208', 'spread': '0.4758', 'groupId': 'OG001'}, {'value': '-0.4444', 'spread': '0.5040', 'groupId': 'OG002'}, {'value': '-0.4514', 'spread': '0.5246', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 2, 4 8 and 12', 'description': "Change from baseline measured by disability index\n\nThe Health Assessment Questionnaire-Disability Index (HAQ-DI) is a subject-reported questionnaire that is commonly used to measure the disease associated disability. It consists of 8 sections which are dressing or grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities.\n\nScores for each functional area were averaged to calculate HAQ-DI scores, ranging from 0 (no disability) to 3 (worst disability), higher score showing more disability.\n\nA decrease in HAQ-DI score indicated an improvement in the participant's condition.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data.'}, {'type': 'SECONDARY', 'title': 'Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Oral administration, twice per day'}, {'id': 'OG001', 'title': 'SKI-O-703 100 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG002', 'title': 'SKI-O-703 200 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG003', 'title': 'SKI-O-703 400 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}], 'classes': [{'title': 'Participants with any Treatment Emergent Adverse Event (TEAE)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'Participants with any treatment-related TEAE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 16', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Oral administration, twice per day'}, {'id': 'OG001', 'title': 'SKI-O-703 100 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG002', 'title': 'SKI-O-703 200 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'OG003', 'title': 'SKI-O-703 400 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}], 'classes': [{'title': 'Participants with any treatment-emergent SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Participants with any treatment-related, treatment-emergent SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 16', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo: Oral administration, twice per day'}, {'id': 'FG001', 'title': 'SKI-O-703 100 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'FG002', 'title': 'SKI-O-703 200 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'FG003', 'title': 'SKI-O-703 400 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Not Specific', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '163', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo: Oral administration, twice per day'}, {'id': 'BG001', 'title': 'SKI-O-703 100 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'BG002', 'title': 'SKI-O-703 200 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'BG003', 'title': 'SKI-O-703 400 mg', 'description': 'SKI-O-703: Oral administration, twice per day'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'spread': '12.03', 'groupId': 'BG000'}, {'value': '56.8', 'spread': '10.90', 'groupId': 'BG001'}, {'value': '55.2', 'spread': '11.51', 'groupId': 'BG002'}, {'value': '52.3', 'spread': '12.80', 'groupId': 'BG003'}, {'value': '54.9', 'spread': '11.84', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age Category', 'categories': [{'title': 'Less than 65 years old', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '128', 'groupId': 'BG004'}]}, {'title': 'Greater than 65 to less than 75 years old', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}, {'title': '75 years old or greater', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '128', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}]}, {'title': 'Black or African-American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'American-Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '166.07', 'spread': '5.995', 'groupId': 'BG000'}, {'value': '165.61', 'spread': '9.003', 'groupId': 'BG001'}, {'value': '163.33', 'spread': '7.918', 'groupId': 'BG002'}, {'value': '163.18', 'spread': '8.098', 'groupId': 'BG003'}, {'value': '164.55', 'spread': '7.867', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '75.68', 'spread': '12.590', 'groupId': 'BG000'}, {'value': '77.09', 'spread': '16.243', 'groupId': 'BG001'}, {'value': '78.71', 'spread': '20.177', 'groupId': 'BG002'}, {'value': '70.83', 'spread': '13.372', 'groupId': 'BG003'}, {'value': '75.56', 'spread': '15.973', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '27.48', 'spread': '4.602', 'groupId': 'BG000'}, {'value': '28.04', 'spread': '5.076', 'groupId': 'BG001'}, {'value': '29.50', 'spread': '7.474', 'groupId': 'BG002'}, {'value': '26.56', 'spread': '4.357', 'groupId': 'BG003'}, {'value': '27.88', 'spread': '5.555', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time since RA onset (years)', 'classes': [{'categories': [{'measurements': [{'value': '9.05', 'spread': '6.418', 'groupId': 'BG000'}, {'value': '6.86', 'spread': '5.587', 'groupId': 'BG001'}, {'value': '6.12', 'spread': '5.578', 'groupId': 'BG002'}, {'value': '8.83', 'spread': '7.260', 'groupId': 'BG003'}, {'value': '7.72', 'spread': '6.321', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nicotine use', 'classes': [{'categories': [{'title': 'Never a smoker or user', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}, {'title': 'Prior smoker or user', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Current smoker or user', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol history', 'classes': [{'categories': [{'title': 'Never a drinker', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '124', 'groupId': 'BG004'}]}, {'title': 'Prior drinker, but no longer a drinker', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Current drinker', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-19', 'size': 16346488, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-03T03:58', 'hasProtocol': True}, {'date': '2020-10-14', 'size': 5731320, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-14T00:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2019-08-13', 'resultsFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-08', 'studyFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Disease Activity Score', 'timeFrame': 'Baseline and Week 12', 'description': 'Mean change from baseline in disease activity score for 28 joints (DAS28) using hsCRP (high sensitivity C-reactive protein).\n\nDisease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), and high sensitivity C-reactive protein (hsCRP) (milligrams per liter). DAS28 was calculated using following formula: DAS28-CRP=0.56\\*square root (sqrt)(TJC28)+0.28\\*sqrt(SJC28)+0.36\\*natural log(hsCRP+1)\\*1.10+1.15.\n\nHigh DAS28-hsCRP value indicates more severe disease activity, by value of \\>5.1 indicating relatively high disease activity, whereas value of \\<3.2 indicating achieved lower disease activity (no theoretical full range available).'}], 'secondaryOutcomes': [{'measure': '• Percentage of Patients With ACR20 (American College of Rheumatology 20) Score', 'timeFrame': 'Baseline and Weeks 2, 4 8 and 12', 'description': "ACR20 score is the percentage of patients showing ≥20% improvement from baseline in tender joint count (68 joint counts), ≥20% improvement in swollen joint count (66 joint counts), and ≥20% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)"}, {'measure': '• Percentage of Patients With ACR50 (American College of Rheumatology 50) Score', 'timeFrame': 'Baseline and Weeks 2, 4 8 and 12', 'description': "ACR50 score is the percentage of patients showing ≥50% improvement from baseline in tender joint count (68 joint counts), ≥50% improvement in swollen joint count (66 joint counts), and ≥50% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)"}, {'measure': '• Percentage of Patients With ACR70 (American College of Rheumatology 70) Score', 'timeFrame': 'Baseline and Weeks 2, 4 8 and 12', 'description': "ACR70 score is the percentage of patients showing ≥70% improvement from baseline in tender joint count (68 joint counts), ≥70% improvement in swollen joint count (66 joint counts), and ≥70% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)"}, {'measure': 'Health Assessment Questionnaire-Disability Index (HAQ-DI) Score', 'timeFrame': 'Baseline and Weeks 2, 4 8 and 12', 'description': "Change from baseline measured by disability index\n\nThe Health Assessment Questionnaire-Disability Index (HAQ-DI) is a subject-reported questionnaire that is commonly used to measure the disease associated disability. It consists of 8 sections which are dressing or grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities.\n\nScores for each functional area were averaged to calculate HAQ-DI scores, ranging from 0 (no disability) to 3 (worst disability), higher score showing more disability.\n\nA decrease in HAQ-DI score indicated an improvement in the participant's condition."}, {'measure': 'Adverse Events (AEs)', 'timeFrame': 'Up to Week 16'}, {'measure': 'Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Week 16'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of SKI-O-703 compared with placebo, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying agents. Patients will be randomly assigned to one of 4 groups and will receive one of three doses of SKI-O-703 or placebo, administered orally twice daily for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must provide written, signed, informed consent.\n* Patients must have a diagnosis of Rheumatoid Arthritis (RA) according to American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism classification, for at least 6 months prior to first administration of study drug.\n* Patients must have active RA at screening and baseline (Day 1 of the study).\n* Patients who have active disease despite csDMARD (conventional synthetic disease-modifying antirheumatic drugs) therapy for at least 3 months prior to Day 1 of the study.\n* Patients must have had an inadequate response to previous anti-TNF⍺ (anti-tumor necrosis factor alpha) biological agent(s) for the treatment of RA and meet the washout period prior to Day 1 of the study.\n\nExclusion Criteria:\n\n* Patients receiving oral agents, except for medications listed in inclusion criteria for the treatment of RA.\n* Patients who have previously received any other or biological agent for the treatment of RA, other than anti-TNF⍺ inhibitor(s).\n* Patients who have a current or past history of hepatitis B virus (HBV) infection; positive test for hepatitis C virus (HCV) antibody; positive test for human immunodeficiency virus (HIV); history of or concurrent interstitial pneumonia; acute infection requiring oral antibiotics within 2 weeks, or parenteral injection of antibiotics within 4 weeks prior to first administration of the study drug; other serious infection within 6 months prior to first administration of study drug; recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to first administration of the study drug; past or current granulomatous infections or other severe or chronic infection; positive test for tuberculosis (TB) or other evidence of TB.\n* Patients with uncontrolled diabetes mellitus, or uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg).\n* Patients with any other inflammatory or rheumatic diseases that could impact the evaluation of the effect of the study drug.\n* Patients with a history of malignancy within 5 years prior to first administration of the study drug, except completely excised and cured squamous cell carcinoma, carcinoma of the cervix in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.\n* New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease or heart attack within 6 months prior to first administration of the study drug.\n* Female patients who are currently pregnant, breastfeeding or planning to become pregnant or breastfeed within 6 months of the last dose of the study drug.\n\nOther protocol-defined inclusion/exclusion criteria could apply.'}, 'identificationModule': {'nctId': 'NCT04057118', 'briefTitle': 'A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oscotec Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies', 'orgStudyIdInfo': {'id': 'OSCO-P2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SKI-O-703 100 mg', 'interventionNames': ['Drug: SKI-O-703']}, {'type': 'EXPERIMENTAL', 'label': 'SKI-O-703 200 mg', 'interventionNames': ['Drug: SKI-O-703']}, {'type': 'EXPERIMENTAL', 'label': 'SKI-O-703 400 mg', 'interventionNames': ['Drug: SKI-O-703']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SKI-O-703', 'type': 'DRUG', 'description': 'Oral administration, twice per day', 'armGroupLabels': ['SKI-O-703 100 mg', 'SKI-O-703 200 mg', 'SKI-O-703 400 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration, twice per day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Oscotec Investigational Site (Site 3110)', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Oscotec Investigational Site (Site 3105)', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Oscotec Investigational (Site 3104)', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Oscotec Investigational Site (Site 3112)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Oscotec Investigational Site (Site 3108)', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oscotec Investigational Site (Site 3102)', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Oscotec Investigational Site (Site 3107)', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '75010', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'Oscotec Investigational Site (3106)', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '77034', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Oscotec Investigational Site (Site 3111)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75150', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Oscotec Investigational Site (Site 3109)', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Oscotec Investigational Site (Site 3103)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'Oscotec Investigational Site (Site 3101)', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '702 00', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Oscotec Investigational Site (Site 2101)', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '760 01', 'city': 'Zlín', 'country': 'Czechia', 'facility': 'Oscotec Investigational Site (Site 2102)', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'zip': '61-397', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'country': 'Poland', 'facility': 'Oscotec Investigational Site (Site 2203)', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '85-168', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Oscotec Investigational Site (Site 2204)', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '53-224', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'Oscotec Investigational Site (Site 2208)', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '20-582', 'city': 'Lublin', 'state': 'Lublin Voivodeship', 'country': 'Poland', 'facility': 'Oscotec Investigational Site (Site 2207)', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '01-518', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Oscotec Investigational Site (Site 2202)', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '15-879', 'city': 'Bialystok', 'state': 'Podlaskie Voivodeship', 'country': 'Poland', 'facility': 'Oscotec Investigational Site (Site 2201)', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '05-830', 'city': 'Nadarzyn', 'country': 'Poland', 'facility': 'Oscotec Investigational Site (Site 2206)', 'geoPoint': {'lat': 52.09438, 'lon': 20.80776}}, {'zip': '27-400', 'city': 'Ostrowiec Świętokrzyski', 'state': 'Świętokrzyskie Voivodeship', 'country': 'Poland', 'facility': 'Oscotec Investigational Site (Site 2209)', 'geoPoint': {'lat': 50.92936, 'lon': 21.38525}}, {'zip': '650066', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Oscotec Investigational Site (Site 2307)', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '119049', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Oscotec Investigational Site (Site 2304)', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129110', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Oscotec Investigational Site (Site 2305)', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '630099', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Oscotec Investigational Site (Site 2308)', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'Oscotec Investigational Site (Site 2306)', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '194291', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Oscotec Investigational Site (Site 2302)', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196084', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Oscotec Investigational Site (Site 2303)', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '634050', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'Oscotec Investigational Site (Site 2301)', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '76018', 'city': 'Ivano-Frankivsk', 'state': 'Ivano-Frankivsk Oblast', 'country': 'Ukraine', 'facility': 'Oscotec Investigational Site (Site 2510)', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '46002', 'city': 'Ternopil', 'state': 'Ternopil Oblast', 'country': 'Ukraine', 'facility': 'Oscotec Investigational Site (Site 2505)', 'geoPoint': {'lat': 49.55404, 'lon': 25.59067}}, {'zip': '21018', 'city': 'Vinnytsia', 'state': 'Vinnytsia Oblast', 'country': 'Ukraine', 'facility': 'Oscotec Investigational Site (Site 2506)', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '21029', 'city': 'Vinnytsia', 'state': 'Vinnytsia Oblast', 'country': 'Ukraine', 'facility': 'Oscotec Investigational Site (Site 2504)', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '61058', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Oscotec Investigational Site (Site 2508)', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '01023', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Oscotec Investigational Site (Site 2501)', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04050', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Oscotec Investigational Site (Site 2503)', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '4107', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Oscotec Investigational Site (Site 2502)', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '36024', 'city': 'Poltava', 'country': 'Ukraine', 'facility': 'Oscotec Investigational Site (Site 2507)', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'zip': '21009', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Oscotec Investigational Site (Site 2509)', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oscotec Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}