Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-02 @ 1:37 AM
Study NCT ID:
NCT02047604
Status:
COMPLETED
Last Update Posted:
2021-06-21
First Post:
2014-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christine.hnatko@valeant.com', 'phone': '9089271162', 'title': 'VP Clinical Services', 'organization': 'Valeant Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A - SAN-300 0.5 mg/kg QW', 'description': 'SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort B - SAN-300 1.0 mg/kg QW', 'description': 'SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort C - SAN-300 2.0 mg/kg QOW', 'description': 'SAN-300 2.0 mg/kg subcutaneous every other week for six weeks', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort D - SAN-300 4.0 mg/kg QOW', 'description': 'SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Cohort E - SAN-300 4.0 mg/kg QW', 'description': 'SAN-300 4.0 mg/kg subcutaneous every week for six weeks', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo', 'description': 'Placebo dosing', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'diarrheoa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Mouth Ulcerations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection Site Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood Pressure Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Electrocardiogram Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Flank Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - SAN-300 0.5 mg/kg QW', 'description': 'SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'OG001', 'title': 'Cohort B - SAN-300 1.0 mg/kg QW', 'description': 'SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'OG002', 'title': 'Cohort C - SAN-300 2.0 mg/kg QOW', 'description': 'SAN-300 2.0 mg/kg subcutaneous every other week for six weeks'}, {'id': 'OG003', 'title': 'Cohort D - SAN-300 4.0 mg/kg QOW', 'description': 'SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks'}, {'id': 'OG004', 'title': 'Cohort E - SAN-300 4.0 mg/kg QW', 'description': 'SAN-300 4.0 mg/kg subcutaneous every week for six weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 weeks', 'description': 'Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - SAN-300 0.5 mg/kg QW', 'description': 'SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'OG001', 'title': 'Cohort B - SAN-300 1.0 mg/kg QW', 'description': 'SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'OG002', 'title': 'Cohort C - SAN-300 2.0 mg/kg QOW', 'description': 'SAN-300 2.0 mg/kg subcutaneous every other week for six weeks'}, {'id': 'OG003', 'title': 'Cohort D - SAN-300 4.0 mg/kg QOW', 'description': 'SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks'}, {'id': 'OG004', 'title': 'Cohort E - SAN-300 4.0 mg/kg QW', 'description': 'SAN-300 4.0 mg/kg subcutaneous every week for six weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.433', 'spread': '1.2736', 'groupId': 'OG000'}, {'value': '-3.663', 'spread': '0.9716', 'groupId': 'OG001'}, {'value': '-2.002', 'spread': '0.8276', 'groupId': 'OG002'}, {'value': '-3.818', 'spread': '1.9164', 'groupId': 'OG003'}, {'value': '-2.928', 'spread': '1.9874', 'groupId': 'OG004'}, {'value': '-3.028', 'spread': '1.2505', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of Treatment Visit (Week 7)', 'description': 'DAS28-CRP= 0.56 x sqrt(TJC28) x sqrt(SJC28) + 0.36 x ln(CRP+1) +0.014 x VAS +0.96 Where TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). CRP: The C-Reactive Protein level (in mg/l). VAS General Health Assessment (from 0=best to 100=worst). ln=natural log. sqrt = square root. Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With American College of Rheumatology 20 (ACR20) Response.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - SAN-300 0.5 mg/kg QW', 'description': 'SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'OG001', 'title': 'Cohort B - SAN-300 1.0 mg/kg QW', 'description': 'SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'OG002', 'title': 'Cohort C - SAN-300 2.0 mg/kg QOW', 'description': 'SAN-300 2.0 mg/kg subcutaneous every other week for six weeks'}, {'id': 'OG003', 'title': 'Cohort D - SAN-300 4.0 mg/kg QOW', 'description': 'SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks'}, {'id': 'OG004', 'title': 'Cohort E - SAN-300 4.0 mg/kg QW', 'description': 'SAN-300 4.0 mg/kg subcutaneous every week for six weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of Treatment Visit (Week 7)', 'description': "A participant is considered to have an ACR20 response if there is an improvement of 20% in all of the following:\n\n* Swollen joint count (66 joints)\n* Tender joint count (68 joints) and\n* At least three of the following five assessments:\n\n * Patient's assessment of pain\n * Patient's global assessment of disease activity\n * Physician's global assessment of disease activity\n * Patient's assessment of physical function, as measured by the HAQ-DI\n * CRP", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Health Assessment Questionnaire-Disease Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - SAN-300 0.5 mg/kg QW', 'description': 'SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'OG001', 'title': 'Cohort B - SAN-300 1.0 mg/kg QW', 'description': 'SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'OG002', 'title': 'Cohort C - SAN-300 2.0 mg/kg QOW', 'description': 'SAN-300 2.0 mg/kg subcutaneous every other week for six weeks'}, {'id': 'OG003', 'title': 'Cohort D - SAN-300 4.0 mg/kg QOW', 'description': 'SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks'}, {'id': 'OG004', 'title': 'Cohort E - SAN-300 4.0 mg/kg QW', 'description': 'SAN-300 4.0 mg/kg subcutaneous every week for six weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.333', 'spread': '0.335', 'groupId': 'OG000'}, {'value': '-0.018', 'spread': '0.064', 'groupId': 'OG001'}, {'value': '-0.146', 'spread': '0.060', 'groupId': 'OG002'}, {'value': '-0.313', 'spread': '0.313', 'groupId': 'OG003'}, {'value': '0.042', 'spread': '0.070', 'groupId': 'OG004'}, {'value': '-0.111', 'spread': '0.129', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of Treatment Visit (Week 7)', 'description': "HAQ assesses the degree of difficulty a participant has had in accomplishing tasks in eight functional areas, over the previous week.\n\n1. dressing and grooming,\n2. rising,\n3. eating,\n4. walking,\n5. hygiene,\n6. reach,\n7. grip,\n8. common daily activities. For each of these categories, participants report amount of difficulty they have in performing two or three specific activities. There are four possible responses for the HAQ questions: without ANY difficulty\n\n(0), with SOME difficulty (1), with MUCH difficulty (2) and UNABLE to do (3). Scores for each of the eight categories are calculated. HAQ is calculated by adjusting the score for each of these categories, if necessary, based upon the patient's use of an aid, device, or assistance for that category, totaling the sum of the category scores and dividing by the number of categories answered. HAQ can range from 0 to 3. Higher scores (greater level of difficulty) indicate worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bone Erosion Detected Using Magnetic Resonance Imaging (MRI) Findings of the Hand and Wrist - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - SAN-300 0.5 mg/kg QW', 'description': 'SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'OG001', 'title': 'Cohort B - SAN-300 1.0 mg/kg QW', 'description': 'SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'OG002', 'title': 'Cohort C - SAN-300 2.0 mg/kg QOW', 'description': 'SAN-300 2.0 mg/kg subcutaneous every other week for six weeks'}, {'id': 'OG003', 'title': 'Cohort D - SAN-300 4.0 mg/kg QOW', 'description': 'SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks'}, {'id': 'OG004', 'title': 'Cohort E - SAN-300 4.0 mg/kg QW', 'description': 'SAN-300 4.0 mg/kg subcutaneous every week for six weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.496', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.214', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0.13', 'spread': '0.125', 'groupId': 'OG003'}, {'value': '0.22', 'spread': '0.222', 'groupId': 'OG004'}, {'value': '0.13', 'spread': '0.125', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, End of Treatment Visit (Week 7)', 'description': 'Bone Erosion detected by MRI of hand/wrist was scored using the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA MRI scoring (RAMRIS) system. Bone erosion was scored 0-10, according to the proportion (in increments of 10%) of erosion of articular bone: 0: 0%, 1: 1%-10%, 2: 11%-20%, ……..10: 91%-100%. Higher scores (more erosion) indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A - SAN-300 0.5 mg/kg QW', 'description': 'SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'FG001', 'title': 'Cohort B - SAN-300 1.0 mg/kg QW', 'description': 'SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'FG002', 'title': 'Cohort C - SAN-300 2.0 mg/kg QOW', 'description': 'SAN-300 2.0 mg/kg subcutaneous every other week for six weeks'}, {'id': 'FG003', 'title': 'Cohort D - SAN-300 4.0 mg/kg QOW', 'description': 'SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks'}, {'id': 'FG004', 'title': 'Cohort E - SAN-300 4.0 mg/kg QW', 'description': 'SAN-300 4.0 mg/kg subcutaneous every week for six weeks'}, {'id': 'FG005', 'title': 'Placebo', 'description': 'Placebo dosing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A - SAN-300 0.5 mg/kg QW', 'description': 'SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'BG001', 'title': 'Cohort B - SAN-300 1.0 mg/kg QW', 'description': 'SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'BG002', 'title': 'Cohort C - SAN-300 2.0 mg/kg QOW', 'description': 'SAN-300 2.0 mg/kg subcutaneous every other week for six weeks'}, {'id': 'BG003', 'title': 'Cohort D - SAN-300 4.0 mg/kg QOW', 'description': 'SAN-300 4.0 mg/kg subcutaneous every other week for six weeks'}, {'id': 'BG004', 'title': 'Cohort E - SAN-300 4.0 mg/kg QW', 'description': 'SAN-300 4.0 mg/kg subcutaneous once weekly for six weeks'}, {'id': 'BG005', 'title': 'Placebo', 'description': 'Placebo dosing'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.2', 'spread': '2.82', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '1.65', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '4.87', 'groupId': 'BG002'}, {'value': '49.0', 'spread': '6.59', 'groupId': 'BG003'}, {'value': '55.5', 'spread': '4.42', 'groupId': 'BG004'}, {'value': '57.5', 'spread': '2.85', 'groupId': 'BG005'}, {'value': '56.6', 'spread': '1.59', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}]}, {'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'}, {'value': '0', 'groupId': 'BG006'}]}]}], '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'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'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'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'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': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-28', 'size': 739728, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-09-13T07:38', 'hasProtocol': True}, {'date': '2017-03-20', 'size': 499698, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-13T07:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-18', 'studyFirstSubmitDate': '2014-01-22', 'resultsFirstSubmitDate': '2018-04-05', 'studyFirstSubmitQcDate': '2014-01-24', 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-18', 'studyFirstPostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in the Health Assessment Questionnaire-Disease Index (HAQ-DI)', 'timeFrame': 'Baseline, End of Treatment Visit (Week 7)', 'description': "HAQ assesses the degree of difficulty a participant has had in accomplishing tasks in eight functional areas, over the previous week.\n\n1. dressing and grooming,\n2. rising,\n3. eating,\n4. walking,\n5. hygiene,\n6. reach,\n7. grip,\n8. common daily activities. For each of these categories, participants report amount of difficulty they have in performing two or three specific activities. There are four possible responses for the HAQ questions: without ANY difficulty\n\n(0), with SOME difficulty (1), with MUCH difficulty (2) and UNABLE to do (3). Scores for each of the eight categories are calculated. HAQ is calculated by adjusting the score for each of these categories, if necessary, based upon the patient's use of an aid, device, or assistance for that category, totaling the sum of the category scores and dividing by the number of categories answered. HAQ can range from 0 to 3. Higher scores (greater level of difficulty) indicate worse outcome."}, {'measure': 'Bone Erosion Detected Using Magnetic Resonance Imaging (MRI) Findings of the Hand and Wrist - Change From Baseline', 'timeFrame': 'Baseline, End of Treatment Visit (Week 7)', 'description': 'Bone Erosion detected by MRI of hand/wrist was scored using the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA MRI scoring (RAMRIS) system. Bone erosion was scored 0-10, according to the proportion (in increments of 10%) of erosion of articular bone: 0: 0%, 1: 1%-10%, 2: 11%-20%, ……..10: 91%-100%. Higher scores (more erosion) indicate worse outcome.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': '10 weeks', 'description': 'Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)', 'timeFrame': 'Baseline, End of Treatment Visit (Week 7)', 'description': 'DAS28-CRP= 0.56 x sqrt(TJC28) x sqrt(SJC28) + 0.36 x ln(CRP+1) +0.014 x VAS +0.96 Where TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). CRP: The C-Reactive Protein level (in mg/l). VAS General Health Assessment (from 0=best to 100=worst). ln=natural log. sqrt = square root. Higher scores indicate worse outcome.'}, {'measure': 'Number of Participants With American College of Rheumatology 20 (ACR20) Response.', 'timeFrame': 'End of Treatment Visit (Week 7)', 'description': "A participant is considered to have an ACR20 response if there is an improvement of 20% in all of the following:\n\n* Swollen joint count (66 joints)\n* Tender joint count (68 joints) and\n* At least three of the following five assessments:\n\n * Patient's assessment of pain\n * Patient's global assessment of disease activity\n * Physician's global assessment of disease activity\n * Patient's assessment of physical function, as measured by the HAQ-DI\n * CRP"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phase 2a multiple ascending dose, Anti-Very Late Antigen-1'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010\n2. 18 to 75 years of age, inclusive, at the time of informed consent\n3. Swollen joint count of ≥ 6 (66-joint count) and tender joint count of ≥ 6 (68-joint count) at Screening and randomization\n4. Inadequate response to therapy or discontinuation of therapy because of unacceptable toxicity from at least one prior traditional or biologic disease-modifying anti-rheumatic drug (DMARD)\n5. Stable dose of methotrexate (≥ 15 mg/week and ≤ 25 mg/week) for ≥ 6 weeks before randomization\n\nExclusion Criteria:\n\n1. Functional Class IV as defined by ACR classification of functional status in RA\n2. History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)\n3. History of malignancy or carcinoma in situ within the 5 years before Screening or any history of melanoma. Patients with history of excised or adequately treated non-melanoma skin cancer are eligible\n4. Evidence of clinically significant uncontrolled concurrent diseases such as cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases\n5. History of recurrent clinically significant infections\n6. Current active infection or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months before randomization\n7. History of severe allergic or anaphylactic reactions to other biologic agents\n8. History of allergies to murine protein\n9. Surgery within 3 months before randomization (other than minor cosmetic surgery or minor dental procedures) or plans for a surgical procedure during the Treatment Period or Follow-up Period\n10. History of tuberculosis or latent infection currently undergoing treatment\n11. History of malaria\n12. Treatment regimen with prednisone that is either over 10 mg/day (or equivalent dose of another corticosteroid) or is not taken at a stable dose of ≤ 10 mg/day for at least 4 weeks before randomization\n13. Intra-articular corticosteroid injection(s) within 4 weeks before randomization\n14. Any live immunization/vaccination, including against Herpes zoster, within 4 weeks before randomization. Live vaccinations must also be avoided throughout the study\n15. Abnormal laboratory value at Screening or Day -1 considered clinically significant\n16. Positive for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)\n17. Positive for human immunodeficiency virus (HIV) antibody\n18. History of tuberculosis or positive QuantiFERON®-TB Gold test (QFT)"}, 'identificationModule': {'nctId': 'NCT02047604', 'briefTitle': '(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients With Active Rheumatoid Arthritis With Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).', 'orgStudyIdInfo': {'id': 'C2013-0302'}, 'secondaryIdInfos': [{'id': '2013-003719-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A - SAN-300 0.5 mg/kg QW', 'description': 'SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks', 'interventionNames': ['Drug: SAN-300 0.5 mg/kg QW']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B - SAN-300 1.0 mg/kg QW', 'description': 'SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks', 'interventionNames': ['Drug: SAN-300 1.0 mg/kg QW']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C - SAN-300 2.0 mg/kg QOW', 'description': 'SAN-300 2.0 mg/kg subcutaneous every other week for six weeks', 'interventionNames': ['Drug: SAN-300 2.0 mg/kg QOW']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D - SAN-300 4.0 mg/kg QOW', 'description': 'SAN-300 4.0 mg/kg subcutaneous every other week for six weeks', 'interventionNames': ['Drug: SAN-300 4.0 mg/kg QOW']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort E - SAN-300 4.0 mg/kg QW', 'description': 'SAN-300 4.0 mg/kg subcutaneous every other week for six weeks', 'interventionNames': ['Drug: SAN-300 4.0 mg/kg QW']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo dosing', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SAN-300 0.5 mg/kg QW', 'type': 'DRUG', 'armGroupLabels': ['Cohort A - SAN-300 0.5 mg/kg QW']}, {'name': 'SAN-300 1.0 mg/kg QW', 'type': 'DRUG', 'armGroupLabels': ['Cohort B - SAN-300 1.0 mg/kg QW']}, {'name': 'SAN-300 2.0 mg/kg QOW', 'type': 'DRUG', 'armGroupLabels': ['Cohort C - SAN-300 2.0 mg/kg QOW']}, {'name': 'SAN-300 4.0 mg/kg QOW', 'type': 'DRUG', 'armGroupLabels': ['Cohort D - SAN-300 4.0 mg/kg QOW']}, {'name': 'SAN-300 4.0 mg/kg QW', 'type': 'DRUG', 'armGroupLabels': ['Cohort E - SAN-300 4.0 mg/kg QW']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 1012', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92020', 'city': 'El Cajon', 'state': 'California', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 1004', 'geoPoint': {'lat': 32.79477, 'lon': -116.96253}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 1008', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94578', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 1011', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 1013', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '34684', 'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 1003', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '63031', 'city': 'Florissant', 'state': 'Missouri', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 1017', 'geoPoint': {'lat': 38.78922, 'lon': -90.32261}}, {'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 1009', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 1019', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 1014', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 1006', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 1001', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}