Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-31 @ 11:22 AM
Study NCT ID:
NCT02057250
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2014-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592401', 'term': 'sarilumab'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D012460', 'term': 'Sulfasalazine'}, {'id': 'D000077339', 'term': 'Leflunomide'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'title': 'Trial Transparency Team', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (74 Weeks) regardless of seriousness or relationship to study drug.', 'description': "Reported AEs are treatment-emergent AEs developed/worsened during 'on treatment period' (time from first dose of IMP in AID assessment phase up to last dose of IMP in extension phase + 6 weeks). Safety population of AID assessment phase included all randomized participants who received at least 1 dose or part of a dose of IMP and safety population of extension phase included all participants who continued in the extension phase and received at least 1 dose or part of a dose of IMP.", 'eventGroups': [{'id': 'EG000', 'title': 'Sarilumab 150 mg by AID (AID Assessment Phase)', 'description': 'Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.', 'otherNumAtRisk': 56, 'otherNumAffected': 29, 'seriousNumAtRisk': 56, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Sarilumab 150 mg by PFS (AID Assessment Phase)', 'description': 'Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.', 'otherNumAtRisk': 53, 'otherNumAffected': 21, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sarilumab 200 mg by AID (AID Assessment Phase)', 'description': 'Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.', 'otherNumAtRisk': 52, 'otherNumAffected': 24, 'seriousNumAtRisk': 52, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Sarilumab 200 mg by PFS (AID Assessment Phase)', 'description': 'Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.', 'otherNumAtRisk': 56, 'otherNumAffected': 23, 'seriousNumAtRisk': 56, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Sarilumab 150 mg by PFS (Extension Phase)', 'description': 'Participants who completed 12 week AID assessment phase received Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.', 'otherNumAtRisk': 188, 'otherNumAffected': 83, 'seriousNumAtRisk': 188, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}], 'seriousEvents': [{'term': 'Bursitis infective staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Wolff-Parkinson-White syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Rheumatoid lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}, {'term': 'Traumatic arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 188, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Validated AID Associated Product Technical Failures (PTFs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'Injections', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg by AID (AID Assessment Phase)', 'description': 'Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 200 mg by AID (AID Assessment Phase)', 'description': 'Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 12', 'description': 'A PTF was defined as any product technical complaint (PTC) related to the use of the AID that had a validated technical cause. Each participant was given a diary having questions related to participant\'s ability to remove the cap, to start the injection, to complete the injection and regarding confirmation of completing the injection. Participants were asked to answer the questions each time they self-inject the sarilumab. If the response was "no" to any of the first 3 questions, this was considered as a PTC. The used AID, for which PTC was reported, was sent to sponsor, examined and evaluated for the occurrence of a PTF.', 'unitOfMeasure': 'PTFs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Injections', 'denomUnitsSelected': 'Injections', 'populationDescription': 'Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of investigational medicinal product (IMP) with AID and attended at least 1 post-baseline visit during AID assessment phase of the study.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg by AID (AID Assessment Phase)', 'description': 'Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 150 mg by PFS (AID Assessment Phase)', 'description': 'Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.'}, {'id': 'OG002', 'title': 'Sarilumab 200 mg by AID (AID Assessment Phase)', 'description': 'Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.'}, {'id': 'OG003', 'title': 'Sarilumab 200 mg by PFS (AID Assessment Phase)', 'description': 'Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.'}], 'classes': [{'title': 'Week 0-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '131', 'spread': '54.5', 'groupId': 'OG000'}, {'value': '152', 'spread': '76.7', 'groupId': 'OG001'}, {'value': '235', 'spread': '117', 'groupId': 'OG002'}, {'value': '227', 'spread': '94.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 10-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '205', 'spread': '126', 'groupId': 'OG000'}, {'value': '220', 'spread': '130', 'groupId': 'OG001'}, {'value': '455', 'spread': '294', 'groupId': 'OG002'}, {'value': '405', 'spread': '244', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0-2: pre-dose on Day 1, anytime post-dose on Day 3, Day 5, Day 8, Day 12, Day 15; Week 10-12: pre-dose on Day 71, anytime post-dose on Day 73, Day 75, Day 78, Day 82, Day 85', 'description': 'AUC(0-tau) is defined as area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval, where dose interval was 2 weeks. Serum concentrations of sarilumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'mg*day/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic(PK) population included all randomized participants who received at least 1 dose of IMP and have least 1 PK parameter calculated using non compartmental methods following the first (Day 1) or sixth administration (Day 71). Here, Number Analyzed = participants with available data for specified category for each arm, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sarilumab 150 mg by AID (AID Assessment Phase)', 'description': 'Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) for 12 weeks.'}, {'id': 'FG001', 'title': 'Sarilumab 150 mg by PFS (AID Assessment Phase)', 'description': 'Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.'}, {'id': 'FG002', 'title': 'Sarilumab 200 mg by AID (AID Assessment Phase)', 'description': 'Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.'}, {'id': 'FG003', 'title': 'Sarilumab 200 mg by PFS (AID Assessment Phase)', 'description': 'Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.'}, {'id': 'FG004', 'title': 'Sarilumab 150 mg by PFS (Extension Phase)', 'description': 'Participants who completed 12 week AID assessment phase received Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.'}], 'periods': [{'title': 'AID Assessment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': '9 participants who completed AID Assessment phase did not enter extension phase.', 'groupId': 'FG004', 'numSubjects': '192'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '15'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'Entered in this period but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'The study was conducted at 53 centers in 6 countries. A total of 419 participants were screened between 18 March 2014 and 14 October 2014, out of which 217 participants were enrolled and treated.', 'preAssignmentDetails': 'Participants were randomized in 1:1:1:1 ratio to Sarilumab 150 mg administered by auto-injector device (AID) or prefilled syringe (PFS) or Sarilumab 200 mg administered by AID or PFS. Participants who completed 12-week AID assessment phase, were treated in open-label extension phase for 52 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '217', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Sarilumab 150 mg by AID (AID Assessment Phase)', 'description': 'Sarilumab 150 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.'}, {'id': 'BG001', 'title': 'Sarilumab 150 mg by PFS (AID Assessment Phase)', 'description': 'Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.'}, {'id': 'BG002', 'title': 'Sarilumab 200 mg by AID (AID Assessment Phase)', 'description': 'Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD for 12 weeks.'}, {'id': 'BG003', 'title': 'Sarilumab 200 mg by PFS (AID Assessment Phase)', 'description': 'Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 12 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '14.2', 'groupId': 'BG001'}, {'value': '55.9', 'spread': '12.3', 'groupId': 'BG002'}, {'value': '50.3', 'spread': '12.8', 'groupId': 'BG003'}, {'value': '53.5', 'spread': '13.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '181', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'dispFirstSubmitDate': '2015-11-16', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2014-01-31', 'dispFirstSubmitQcDate': '2015-11-16', 'resultsFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2014-02-05', 'dispFirstPostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-23', 'studyFirstPostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Validated AID Associated Product Technical Failures (PTFs)', 'timeFrame': 'Baseline up to Week 12', 'description': 'A PTF was defined as any product technical complaint (PTC) related to the use of the AID that had a validated technical cause. Each participant was given a diary having questions related to participant\'s ability to remove the cap, to start the injection, to complete the injection and regarding confirmation of completing the injection. Participants were asked to answer the questions each time they self-inject the sarilumab. If the response was "no" to any of the first 3 questions, this was considered as a PTC. The used AID, for which PTC was reported, was sent to sponsor, examined and evaluated for the occurrence of a PTF.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab', 'timeFrame': 'Week 0-2: pre-dose on Day 1, anytime post-dose on Day 3, Day 5, Day 8, Day 12, Day 15; Week 10-12: pre-dose on Day 71, anytime post-dose on Day 73, Day 75, Day 78, Day 82, Day 85', 'description': 'AUC(0-tau) is defined as area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval, where dose interval was 2 weeks. Serum concentrations of sarilumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['RA']}, 'referencesModule': {'references': [{'pmid': '29209946', 'type': 'DERIVED', 'citation': 'Kivitz A, Baret-Cormel L, van Hoogstraten H, Wang S, Parrino J, Xu C, Stanislav M. Usability and Patient Preference Phase 3 Study of the Sarilumab Pen in Patients with Active Moderate-to-Severe Rheumatoid Arthritis. Rheumatol Ther. 2018 Jun;5(1):231-242. doi: 10.1007/s40744-017-0090-2. Epub 2017 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants.\n\nSecondary Objective:\n\nTo compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).', 'detailedDescription': 'Total study duration up to 74 weeks: screening up to 4 weeks, AID assessment phase of 12 weeks, extension phase of 52 weeks and post-treatment follow-up of 6 weeks.\n\nFor participants not entering the extension phase, total study duration up to 22 weeks (screening, AID assessment phase and follow-up).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Diagnosis of RA, ≥3 months disease duration;\n* Participant willing and able to self-inject;\n* Continuous treatment with 1 or a combination of non-biologic disease modifying antirheumatic drugs (DMARDs) (except leflunomide in combination with methotrexate);\n* Moderate-to-severely active RA.\n\nExclusion criteria:\n\n* Participants \\<18 years;\n* Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonists;\n* Treatment with tumor necrosis factor (TNF) antagonists;\n* Treatment with RA-directed biologic agents other than with a TNF-α antagonist mechanism as follows: Anakinra, Abatacept, Rituximab or other cell-depleting agent;\n* Prior treatment with a Janus kinase inhibitor.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02057250', 'acronym': 'SARIL-RA-EASY', 'briefTitle': 'To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy', 'orgStudyIdInfo': {'id': 'MSC12665'}, 'secondaryIdInfos': [{'id': '2012-004339-21'}, {'id': 'U1111-1130-9931', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sarilumab 150 mg by AID', 'description': 'Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.', 'interventionNames': ['Drug: Sarilumab', 'Device: Auto-Injector Device (AID)', 'Drug: Methotrexate', 'Drug: Sulfasalazine', 'Drug: Leflunomide', 'Drug: Hydroxychloroquine']}, {'type': 'EXPERIMENTAL', 'label': 'Sarilumab 150 mg by PFS', 'description': 'Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.', 'interventionNames': ['Drug: Sarilumab', 'Device: Pre-filled Syringe (PFS)', 'Drug: Methotrexate', 'Drug: Sulfasalazine', 'Drug: Leflunomide', 'Drug: Hydroxychloroquine']}, {'type': 'EXPERIMENTAL', 'label': 'Sarilumab 200 mg by AID', 'description': 'Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.', 'interventionNames': ['Drug: Sarilumab', 'Device: Auto-Injector Device (AID)', 'Drug: Methotrexate', 'Drug: Sulfasalazine', 'Drug: Leflunomide', 'Drug: Hydroxychloroquine']}, {'type': 'EXPERIMENTAL', 'label': 'Sarilumab 200 mg by PFS', 'description': 'Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.', 'interventionNames': ['Drug: Sarilumab', 'Device: Pre-filled Syringe (PFS)', 'Drug: Methotrexate', 'Drug: Sulfasalazine', 'Drug: Leflunomide', 'Drug: Hydroxychloroquine']}], 'interventions': [{'name': 'Sarilumab', 'type': 'DRUG', 'otherNames': ['SAR153191', 'REGN88'], 'description': 'Pharmaceutical form: Solution Route of administration: Subcutaneous', 'armGroupLabels': ['Sarilumab 150 mg by AID', 'Sarilumab 150 mg by PFS', 'Sarilumab 200 mg by AID', 'Sarilumab 200 mg by PFS']}, {'name': 'Auto-Injector Device (AID)', 'type': 'DEVICE', 'armGroupLabels': ['Sarilumab 150 mg by AID', 'Sarilumab 200 mg by AID']}, {'name': 'Pre-filled Syringe (PFS)', 'type': 'DEVICE', 'armGroupLabels': ['Sarilumab 150 mg by PFS', 'Sarilumab 200 mg by PFS']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Dispensed according to local practice.', 'armGroupLabels': ['Sarilumab 150 mg by AID', 'Sarilumab 150 mg by PFS', 'Sarilumab 200 mg by AID', 'Sarilumab 200 mg by PFS']}, {'name': 'Sulfasalazine', 'type': 'DRUG', 'description': 'Dispensed according to local practice.', 'armGroupLabels': ['Sarilumab 150 mg by AID', 'Sarilumab 150 mg by PFS', 'Sarilumab 200 mg by AID', 'Sarilumab 200 mg by PFS']}, {'name': 'Leflunomide', 'type': 'DRUG', 'description': 'Dispensed according to local practice.', 'armGroupLabels': ['Sarilumab 150 mg by AID', 'Sarilumab 150 mg by PFS', 'Sarilumab 200 mg by AID', 'Sarilumab 200 mg by PFS']}, {'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Dispensed according to local practice.', 'armGroupLabels': ['Sarilumab 150 mg by AID', 'Sarilumab 150 mg by PFS', 'Sarilumab 200 mg by AID', 'Sarilumab 200 mg by PFS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 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