Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-04-13 @ 9:34 PM
Study NCT ID:
NCT02776735
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2016-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Estonia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592401', 'term': 'sarilumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', 'organization': 'Sanofi aventis recherche & développement'}, 'certainAgreement': {'otherDetails': 'The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3.', 'description': 'Analysis was performed on the safety analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cohort 2 (From Baseline): >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w during the entire treatment period.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 39, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Cohort 1 Portion 1, Post Dose-adjustment From Dose 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w after switched from Dose/Cohort 1 to selected Dose 2.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 3 Portion 1, Post Dose-adjustment From Dose 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w after switched from Dose/Cohort 3 to selected Dose 2.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort 2 (From Baseline): < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w during the entire treatment period.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 29, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Cohort 1 Portion 1, Post Dose-adjustment From Dose 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w after switched from Dose/Cohort 1 to selected Dose 2.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Cohort 3 Portion 1, Post Dose-adjustment From Dose 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w after switched from Dose/Cohort 3 to selected Dose 2.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 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lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 23, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 78, 'numAffected': 15}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Cardiovascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 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{'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Dental Discomfort', 'stats': 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'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Infectious Mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Ligament Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Meniscus Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Juvenile Idiopathic Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}, {'term': 'Tonsillar Hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Serum Concentration (Cmax) of Sarilumab at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG004', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG005', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.57', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '22.0', 'spread': '8.07', 'groupId': 'OG002'}, {'value': '33.6', 'spread': '7.16', 'groupId': 'OG003'}, {'value': '32.0', 'spread': '7.27', 'groupId': 'OG004'}, {'value': '31.0', 'spread': '7.98', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12', 'description': 'The Cmax was defined as maximum serum concentration. The values reported are mean and standard deviation.', 'unitOfMeasure': 'milligram per liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) analysis set included all participants in the safety population with at least 1 post-dose, non-missing serum concentration value. Only participants with data collected are reported.'}, {'type': 'PRIMARY', 'title': 'Area Under the Serum Concentration Versus Time Curve Using the Trapezoidal Method During a Dose Interval (AUC0-t) of Sarilumab at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG004', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG005', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '106', 'spread': '36.8', 'groupId': 'OG001'}, {'value': '212', 'spread': '77.2', 'groupId': 'OG002'}, {'value': '318', 'spread': '90.0', 'groupId': 'OG003'}, {'value': '202', 'spread': '55.0', 'groupId': 'OG004'}, {'value': '192', 'spread': '60.7', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12', 'description': 'The AUC0-t was defined as area under the concentration in serum versus time curve calculated using the trapezoidal method during a dose interval (tau). The values reported are mean and standard deviation.', 'unitOfMeasure': 'day*mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants in the safety population with at least 1 post-dose, non-missing serum concentration value. Only participants with data collected are reported.'}, {'type': 'PRIMARY', 'title': 'Concentration Before Treatment Administration During Repeated Dosing (Ctrough) of Sarilumab at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG004', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG005', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.30', 'spread': '0.952', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '5.76', 'spread': '3.57', 'groupId': 'OG002'}, {'value': '9.88', 'spread': '5.42', 'groupId': 'OG003'}, {'value': '22.2', 'spread': '7.12', 'groupId': 'OG004'}, {'value': '23.2', 'spread': '8.28', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12', 'description': 'The Ctrough was defined as concentration observed before treatment administration during repeated dosing from baseline to Week 12. The values reported are mean and standard deviation.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants in the safety population with at least 1 post-dose, non-missing serum concentration value. Only participants with data collected are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '3.64', 'groupId': 'OG001'}, {'value': '-5.71', 'spread': '8.90', 'groupId': 'OG002'}, {'value': '-6.83', 'spread': '11.74', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'Serum concentrations of hs-CRP was determined to assess the Pharmacodynamic (PD) effects of sarilumab. The values reported are mean and standard deviation.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated population included participants who signed informed consent and received at least 1 dose of the study treatment. Only participants analyzed at baseline and Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Change From Baseline in High-Sensitivity C-reactive Protein at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.54', 'spread': '33.57', 'groupId': 'OG000'}, {'value': '-20.66', 'spread': '48.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.54', 'spread': '19.17', 'groupId': 'OG000'}, {'value': '-11.72', 'spread': '23.54', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.93', 'spread': '21.60', 'groupId': 'OG000'}, {'value': '-12.57', 'spread': '24.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.39', 'spread': '21.65', 'groupId': 'OG000'}, {'value': '-13.88', 'spread': '25.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.10', 'spread': '14.68', 'groupId': 'OG000'}, {'value': '-12.30', 'spread': '26.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'Serum concentrations of hs-CRP was determined to assess the PD effects of sarilumab. The values reported are mean and standard deviation.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated population included participants who signed informed consent and received at least 1 dose of the study treatment. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Interleukin-6 (IL-6) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG004', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG005', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '9.79', 'groupId': 'OG000'}, {'value': '13.65', 'spread': '18.20', 'groupId': 'OG001'}, {'value': '43.71', 'spread': '113.42', 'groupId': 'OG002'}, {'value': '11.36', 'spread': '35.81', 'groupId': 'OG003'}, {'value': '66.21', 'spread': '86.21', 'groupId': 'OG004'}, {'value': '9.20', 'spread': '26.50', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'Serum concentrations of IL-6 was determined to assess the PD effects of sarilumab. The values reported are mean and standard deviation.', 'unitOfMeasure': 'nanogram (ng)/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated population included participants who signed informed consent and received at least 1 dose of the study treatment. Only participants with data collected at Baseline and Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Soluble Interleukin-6 Receptor (sIL-6R) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG004', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG005', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '40.09', 'spread': '49.75', 'groupId': 'OG000'}, {'value': '101.50', 'spread': '129.59', 'groupId': 'OG001'}, {'value': '316.77', 'spread': '129.29', 'groupId': 'OG002'}, {'value': '388.33', 'spread': '185.82', 'groupId': 'OG003'}, {'value': '535.76', 'spread': '98.12', 'groupId': 'OG004'}, {'value': '582.95', 'spread': '149.52', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'Serum concentrations of sIL-6R was determined to assess the PD effects of sarilumab. The values reported are mean and standard deviation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated population included participants who signed informed consent and received at least 1 dose of the study treatment. Only participants with data collected at Baseline and Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology (JIA ACR) 30 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'JIA ACR30 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 30% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 30 Response at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 24, 48, 96, and 156', 'description': 'JIA ACR30 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 30% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 50 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'JIA ACR50 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 50% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 50 Response at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000'}, {'value': '96.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 24, 48, 96, and 156', 'description': 'JIA ACR50 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 50% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 70 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'JIA ACR70 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 70% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 70 Response at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000'}, {'value': '89.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.2', 'groupId': 'OG000'}, {'value': '96.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 24, 48, 96, and 156', 'description': 'JIA ACR70 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 70% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 90 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}, {'value': '60.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'JIA ACR90 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 90% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 90 Response at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000'}, {'value': '48.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000'}, {'value': '74.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000'}, {'value': '88.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000'}, {'value': '95.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 24, 48, 96, and 156', 'description': 'JIA ACR90 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 90% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 100 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '40.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'JIA ACR100 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 100% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 100 Response at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '24.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '48.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.2', 'groupId': 'OG000'}, {'value': '70.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}, {'value': '87.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 24, 48, 96, and 156', 'description': 'JIA ACR100 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 100% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Activity Joint Count-71, at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.40', 'spread': '2.159', 'groupId': 'OG000'}, {'value': '-11.20', 'spread': '2.871', 'groupId': 'OG001'}, {'value': '-16.50', 'spread': '4.137', 'groupId': 'OG002'}, {'value': '-14.40', 'spread': '5.573', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using visual analog scale (VAS), Childhood Health Questionnaire Disability Index (CHAQ-DI) and hs-CRP. Activity joint count-71 was calculated as sum (joints with active arthritis)\\*(71/number of joints with assessment).', 'unitOfMeasure': 'joint', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Activity Joint Count-71, at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.15', 'spread': '1.511', 'groupId': 'OG000'}, {'value': '-12.38', 'spread': '1.519', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.66', 'spread': '1.497', 'groupId': 'OG000'}, {'value': '-13.26', 'spread': '1.575', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.24', 'spread': '1.547', 'groupId': 'OG000'}, {'value': '-13.73', 'spread': '1.618', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.47', 'spread': '1.682', 'groupId': 'OG000'}, {'value': '-13.79', 'spread': '1.751', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.65', 'spread': '2.334', 'groupId': 'OG000'}, {'value': '-13.88', 'spread': '2.495', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Activity joint count-71 was calculated as sum (joints with active arthritis)\\*(71/number of joints with assessment).', 'unitOfMeasure': 'joint', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Limited Motion Joint Count, at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.80', 'spread': '2.083', 'groupId': 'OG000'}, {'value': '-5.80', 'spread': '2.267', 'groupId': 'OG001'}, {'value': '-7.83', 'spread': '2.600', 'groupId': 'OG002'}, {'value': '-13.00', 'spread': '4.219', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Limited motion joint count was calculated as sum (joints with limited motion)\\*(67/number of joints with assessment).', 'unitOfMeasure': 'joint', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Limited Motion Joint Count, at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.71', 'spread': '1.249', 'groupId': 'OG000'}, {'value': '-9.21', 'spread': '1.540', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.40', 'spread': '1.330', 'groupId': 'OG000'}, {'value': '-10.63', 'spread': '1.559', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.99', 'spread': '1.498', 'groupId': 'OG000'}, {'value': '-10.73', 'spread': '1.525', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.14', 'spread': '1.661', 'groupId': 'OG000'}, {'value': '-10.42', 'spread': '1.493', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.29', 'spread': '2.203', 'groupId': 'OG000'}, {'value': '-11.81', 'spread': '2.550', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Limited motion joint count was calculated as sum (joints with limited motion)\\*(67/number of joints with assessment).', 'unitOfMeasure': 'joint', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Childhood Health Assessment Questionnaire Disability Index, at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.242', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '0.239', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '0.173', 'groupId': 'OG002'}, {'value': '-0.75', 'spread': '0.213', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. The CHAQ questionnaire consists of 30 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain is scored on a 4 point scale ranges from 0 to 3: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). An additional response of "not applicable" is available to indicate activities the participant is unable to perform because he/she is too young. The CHAQ-DI total score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst). Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Childhood Health Assessment Questionnaire Disability Index, at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.092', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.113', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.90', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '-0.95', 'spread': '0.132', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.084', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '0.119', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.92', 'spread': '0.109', 'groupId': 'OG000'}, {'value': '-1.13', 'spread': '0.136', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.07', 'spread': '0.163', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.169', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. The CHAQ questionnaire consists of 30 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain is scored on a 4 point scale ranges from 0 to 3: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). An additional response of "not applicable" is available to indicate activities the participant is unable to perform because he/she is too young. The CHAQ-DI total score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst). Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, C-Reactive Protein, at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.130', 'groupId': 'OG000'}, {'value': '-1.67', 'spread': '1.139', 'groupId': 'OG001'}, {'value': '-5.71', 'spread': '3.633', 'groupId': 'OG002'}, {'value': '-2.54', 'spread': '1.845', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Serum concentrations of hs-CRP was determined to assess the PD effects of sarilumab.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, C-Reactive Protein, at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.84', 'spread': '5.437', 'groupId': 'OG000'}, {'value': '-20.66', 'spread': '9.304', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.54', 'spread': '3.151', 'groupId': 'OG000'}, {'value': '-11.72', 'spread': '4.371', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.93', 'spread': '3.505', 'groupId': 'OG000'}, {'value': '-12.57', 'spread': '4.664', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.39', 'spread': '3.608', 'groupId': 'OG000'}, {'value': '-13.88', 'spread': '5.414', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.10', 'spread': '3.671', 'groupId': 'OG000'}, {'value': '-12.30', 'spread': '6.672', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Serum concentrations of hs-CRP was determined to assess the PD effects of sarilumab.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Physician Global Assessment of Disease Activity, at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.56', 'spread': '0.969', 'groupId': 'OG000'}, {'value': '-6.30', 'spread': '0.397', 'groupId': 'OG001'}, {'value': '-4.55', 'spread': '0.509', 'groupId': 'OG002'}, {'value': '-5.68', 'spread': '1.163', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Physician global assessment of disease activity was assessed on an anchored 100 mm horizontal VAS score ranging from 0 to 10 where 0 is considered the best disease activity (no disease activity) and 10 the worst (most disease activity). Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Physician Global Assessment of Disease Activity, at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.50', 'spread': '0.248', 'groupId': 'OG000'}, {'value': '-4.09', 'spread': '0.367', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.99', 'spread': '0.237', 'groupId': 'OG000'}, {'value': '-5.01', 'spread': '0.341', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.27', 'spread': '0.263', 'groupId': 'OG000'}, {'value': '-5.25', 'spread': '0.321', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.30', 'spread': '0.306', 'groupId': 'OG000'}, {'value': '-5.35', 'spread': '0.347', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.66', 'spread': '0.396', 'groupId': 'OG000'}, {'value': '-5.73', 'spread': '0.437', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Physician global assessment of disease activity was assessed on an anchored 100 mm horizontal VAS score ranging from 0 to 10 where 0 is considered the best disease activity (no disease activity) and 10 the worst (most disease activity). Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Participant/Parent Assessment of Overall Well-Being, at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.30', 'spread': '1.014', 'groupId': 'OG000'}, {'value': '-3.16', 'spread': '1.364', 'groupId': 'OG001'}, {'value': '-3.05', 'spread': '0.992', 'groupId': 'OG002'}, {'value': '-5.00', 'spread': '0.969', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Participant/parent assessment of overall well-being was rated on an anchored 100 mm horizontal VAS score ranging from 0 to 10 where 0 is considered the best disease activity (no disease activity) and 10 the worst (most disease activity). Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Participant/Parent Assessment of Overall Well-Being, at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.73', 'spread': '0.335', 'groupId': 'OG000'}, {'value': '-4.01', 'spread': '0.435', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.38', 'spread': '0.313', 'groupId': 'OG000'}, {'value': '-4.39', 'spread': '0.475', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.21', 'spread': '0.356', 'groupId': 'OG000'}, {'value': '-4.64', 'spread': '0.510', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.36', 'spread': '0.387', 'groupId': 'OG000'}, {'value': '-5.09', 'spread': '0.521', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.19', 'spread': '0.738', 'groupId': 'OG000'}, {'value': '-5.01', 'spread': '0.636', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Participant/parent assessment of overall well-being was rated on an anchored 100 mm horizontal VAS score ranging from 0 to 10 where 0 is considered the best disease activity (no disease activity) and 10 the worst (most disease activity). Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 3: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS-27) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'title': 'JADAS-27-ESR: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-15.4', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '-19.1', 'spread': '3.05', 'groupId': 'OG001'}, {'value': '-20.0', 'spread': '3.82', 'groupId': 'OG002'}, {'value': '-19.4', 'spread': '6.01', 'groupId': 'OG003'}]}]}, {'title': 'JADAS-27-CRP: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16.0', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '-18.1', 'spread': '2.62', 'groupId': 'OG001'}, {'value': '-18.5', 'spread': '3.42', 'groupId': 'OG002'}, {'value': '-21.1', 'spread': '4.96', 'groupId': 'OG003'}]}]}, {'title': 'Clinical JADAS-27: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16.1', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '-18.1', 'spread': '2.62', 'groupId': 'OG001'}, {'value': '-18.3', 'spread': '3.28', 'groupId': 'OG002'}, {'value': '-21.1', 'spread': '4.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JADAS is used for assessment of disease activity, and it includes 4 measures: Physician global assessment of disease activity (VAS range: 0 to10; where 0= no activity and 10= maximum activity), parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and10= maximum activity), count of joints with active disease (range: 0 to 27; where 0= no activity and 27= maximum activity), and index of inflammation determined by hs-CRP or ESR (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity). The JADAS total score is calculated as the simple sum of the scores of its 4 components. The total score ranges from 0 to 57 where 0= no disease activity and 57= maximum disease activity. Higher scores indicate higher disease activity. Clinical JADAS-27 is without CRP or ESR component and score ranges from 0 to 47 where 0= no disease activity and 47= maximum disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.'}, {'type': 'SECONDARY', 'title': 'Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}], 'classes': [{'title': 'JADAS-27-ESR: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.9', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '-16.9', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'JADAS-27-ESR: Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.9', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '-18.3', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'JADAS-27-ESR: Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.3', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '-19.4', 'spread': '1.61', 'groupId': 'OG001'}]}]}, {'title': 'JADAS-27-ESR: Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.4', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '-20.4', 'spread': '1.84', 'groupId': 'OG001'}]}]}, {'title': 'JADAS-27-ESR: Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.2', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '-20.6', 'spread': '2.57', 'groupId': 'OG001'}]}]}, {'title': 'JADAS-27-CRP: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.2', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-16.3', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'JADAS-27-CRP: Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.9', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-18.8', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'JADAS-27-CRP: Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.6', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '-19.4', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'JADAS-27-CRP: Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.9', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '-20.1', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'JADAS-27-CRP: Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.8', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-20.2', 'spread': '2.24', 'groupId': 'OG001'}]}]}, {'title': 'Clinical JADAS-27: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.9', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '-16.0', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Clinical JADAS-27: Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.5', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-18.0', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'Clinical JADAS-27: Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.0', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '-18.8', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'Clinical JADAS-27: Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.2', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '-19.5', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Clinical JADAS-27: Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.2', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '-19.3', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JADAS is used for assessment of disease activity, and it includes 4 measures: Physician global assessment of disease activity (VAS range: 0 to10; where 0= no activity and 10= maximum activity), parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and10= maximum activity), count of joints with active disease (range: 0 to 27; where 0= no activity and 27= maximum activity), and index of inflammation determined by hs-CRP or ESR (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity). The JADAS total score is calculated as the simple sum of the scores of its 4 components. The total score ranges from 0 to 57 where 0= no disease activity and 57= maximum disease activity. Higher scores indicate higher disease activity. Clinical JADAS-27 is without CRP or ESR component and score ranges from 0 to 47 where 0= no disease activity and 47= maximum disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG004', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG005', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}, {'title': 'Any treatment emergent SAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first administration of study treatment (Day 1) up to end of treatment period, maximum of 156 weeks for portions 1 and 2 and 96 weeks for portion 3', 'description': 'An adverse events (AEs) is any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. TEAEs are defined as AEs that develop or worsen during the on-treatment period \\[that is, from the time of first dose of study treatment up to 6 weeks after the last administration of the study treatment\\].', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set included all participants who received at least 1 dose or part of a dose of the study treatment, analyzed according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Local Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG002', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG003', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'OG004', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'OG005', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first administration of study treatment (Day 1) up to end of treatment period, maximum of 156 weeks for portions 1 and 2 and 96 weeks for portion 3', 'description': 'Participants were observed for at least 30 minutes after each study treatment administration either on site or at home and any local reactions were noted in the diary regardless of being clinically significant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set included all participants who received at least 1 dose or part of a dose of the study treatment, analyzed according to the treatment actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kilograms (kg) and \\<= 60 kg received sarilumab 2 mg/kg subcutaneous (SC) injection once every other week (q2w) for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'FG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'FG002', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'FG003', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'FG004', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection once every week (qw) for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'FG005', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Group A: \\>=30kg and \\<=60kg and Group B: \\<30kg and \\>=10kg. Portion 1 of study enrolled participants into 3 dosing regimens (Cohort 1, 2 and 3). Cohort 1: dose capped at 150mg q2w (Group A:2mg/kg q2w; Group B:2.5mg/kg q2w). Cohort 2: dose capped at 200mg q2w (Group A:3mg/kg q2w; Group B:4mg/kg q2w). Cohort 3: dose capped at 150mg qw (Group A:2mg/kg qw; Group B:2.5mg/kg qw). All 3 cohorts in Portion 1 received 12-week core treatment phase and eligible participants entered 144-week extension phase.', 'preAssignmentDetails': 'After dose-finding portion, 200mg q2w dose was selected for continuation in study. Portion 1 participants from Cohorts 1 and 3 who continued into extension phase switched to this dose after dose was selected. Participants enrolled into Portions 2 and 3 started on selected dose of 200mg q2w capped dose (Group A: 3 mg/kg q2w; Group B: 4 mg/kg q2w) for extension phase (144 weeks for Portion 2 and 84 weeks for Portion 3). A total of 102 participants were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '101', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'BG001', 'title': 'Cohort 1: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'BG002', 'title': 'Cohort 2: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'BG003', 'title': 'Cohort 2: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).'}, {'id': 'BG004', 'title': 'Cohort 3: >= 30 kg and <= 60 kg', 'description': 'Participants with body weight \\>= 30 kg and \\<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'BG005', 'title': 'Cohort 3: < 30 kg and >= 10 kg', 'description': 'Participants with body weight \\< 30 kg and \\>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '6.5', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '12.6', 'spread': '3.0', 'groupId': 'BG002'}, {'value': '5.4', 'spread': '3.1', 'groupId': 'BG003'}, {'value': '13.7', 'spread': '3.0', 'groupId': 'BG004'}, {'value': '4.8', 'spread': '2.4', 'groupId': 'BG005'}, {'value': '9.4', 'spread': '4.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '77', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', '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': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Black or African American', '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': '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': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '88', 'groupId': 'BG006'}]}, {'title': 'Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All treated population included participants who signed informed consent and received at least 1 dose of the study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-12', 'size': 17654088, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-03T13:51', 'hasProtocol': True}, {'date': '2019-09-12', 'size': 2207123, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-03T13:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'dispFirstSubmitDate': '2023-04-07', 'completionDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2016-05-16', 'resultsFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2016-05-16', 'dispFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-07', 'studyFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Serum Concentration (Cmax) of Sarilumab at Week 12', 'timeFrame': 'Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12', 'description': 'The Cmax was defined as maximum serum concentration. The values reported are mean and standard deviation.'}, {'measure': 'Area Under the Serum Concentration Versus Time Curve Using the Trapezoidal Method During a Dose Interval (AUC0-t) of Sarilumab at Week 12', 'timeFrame': 'Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12', 'description': 'The AUC0-t was defined as area under the concentration in serum versus time curve calculated using the trapezoidal method during a dose interval (tau). The values reported are mean and standard deviation.'}, {'measure': 'Concentration Before Treatment Administration During Repeated Dosing (Ctrough) of Sarilumab at Week 12', 'timeFrame': 'Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12', 'description': 'The Ctrough was defined as concentration observed before treatment administration during repeated dosing from baseline to Week 12. The values reported are mean and standard deviation.'}], 'secondaryOutcomes': [{'measure': 'Cohorts 1 and 3: Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'Serum concentrations of hs-CRP was determined to assess the Pharmacodynamic (PD) effects of sarilumab. The values reported are mean and standard deviation.'}, {'measure': 'Cohort 2: Change From Baseline in High-Sensitivity C-reactive Protein at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'Serum concentrations of hs-CRP was determined to assess the PD effects of sarilumab. The values reported are mean and standard deviation.'}, {'measure': 'Change From Baseline in Interleukin-6 (IL-6) at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'Serum concentrations of IL-6 was determined to assess the PD effects of sarilumab. The values reported are mean and standard deviation.'}, {'measure': 'Change From Baseline in Total Soluble Interleukin-6 Receptor (sIL-6R) at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'Serum concentrations of sIL-6R was determined to assess the PD effects of sarilumab. The values reported are mean and standard deviation.'}, {'measure': 'Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology (JIA ACR) 30 Response at Week 12', 'timeFrame': 'Week 12', 'description': 'JIA ACR30 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 30% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.'}, {'measure': 'Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 30 Response at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Weeks 12, 24, 48, 96, and 156', 'description': 'JIA ACR30 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 30% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.'}, {'measure': 'Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 50 Response at Week 12', 'timeFrame': 'Week 12', 'description': 'JIA ACR50 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 50% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.'}, {'measure': 'Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 50 Response at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Weeks 12, 24, 48, 96, and 156', 'description': 'JIA ACR50 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 50% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.'}, {'measure': 'Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 70 Response at Week 12', 'timeFrame': 'Week 12', 'description': 'JIA ACR70 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 70% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.'}, {'measure': 'Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 70 Response at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Weeks 12, 24, 48, 96, and 156', 'description': 'JIA ACR70 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 70% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.'}, {'measure': 'Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 90 Response at Week 12', 'timeFrame': 'Week 12', 'description': 'JIA ACR90 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 90% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.'}, {'measure': 'Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 90 Response at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Weeks 12, 24, 48, 96, and 156', 'description': 'JIA ACR90 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 90% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.'}, {'measure': 'Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 100 Response at Week 12', 'timeFrame': 'Week 12', 'description': 'JIA ACR100 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 100% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.'}, {'measure': 'Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 100 Response at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Weeks 12, 24, 48, 96, and 156', 'description': 'JIA ACR100 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \\>= 100% improvement from baseline with no more than 1 of the remaining variables worsened by \\>= 30%.'}, {'measure': 'Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Activity Joint Count-71, at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using visual analog scale (VAS), Childhood Health Questionnaire Disability Index (CHAQ-DI) and hs-CRP. Activity joint count-71 was calculated as sum (joints with active arthritis)\\*(71/number of joints with assessment).'}, {'measure': 'Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Activity Joint Count-71, at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Activity joint count-71 was calculated as sum (joints with active arthritis)\\*(71/number of joints with assessment).'}, {'measure': 'Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Limited Motion Joint Count, at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Limited motion joint count was calculated as sum (joints with limited motion)\\*(67/number of joints with assessment).'}, {'measure': 'Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Limited Motion Joint Count, at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Limited motion joint count was calculated as sum (joints with limited motion)\\*(67/number of joints with assessment).'}, {'measure': 'Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Childhood Health Assessment Questionnaire Disability Index, at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. The CHAQ questionnaire consists of 30 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain is scored on a 4 point scale ranges from 0 to 3: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). An additional response of "not applicable" is available to indicate activities the participant is unable to perform because he/she is too young. The CHAQ-DI total score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst). Higher scores indicate worse outcome.'}, {'measure': 'Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Childhood Health Assessment Questionnaire Disability Index, at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. The CHAQ questionnaire consists of 30 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain is scored on a 4 point scale ranges from 0 to 3: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). An additional response of "not applicable" is available to indicate activities the participant is unable to perform because he/she is too young. The CHAQ-DI total score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst). Higher scores indicate worse outcome.'}, {'measure': 'Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, C-Reactive Protein, at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Serum concentrations of hs-CRP was determined to assess the PD effects of sarilumab.'}, {'measure': 'Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, C-Reactive Protein, at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Serum concentrations of hs-CRP was determined to assess the PD effects of sarilumab.'}, {'measure': 'Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Physician Global Assessment of Disease Activity, at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Physician global assessment of disease activity was assessed on an anchored 100 mm horizontal VAS score ranging from 0 to 10 where 0 is considered the best disease activity (no disease activity) and 10 the worst (most disease activity). Higher scores indicate worse outcome.'}, {'measure': 'Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Physician Global Assessment of Disease Activity, at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Physician global assessment of disease activity was assessed on an anchored 100 mm horizontal VAS score ranging from 0 to 10 where 0 is considered the best disease activity (no disease activity) and 10 the worst (most disease activity). Higher scores indicate worse outcome.'}, {'measure': 'Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Participant/Parent Assessment of Overall Well-Being, at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Participant/parent assessment of overall well-being was rated on an anchored 100 mm horizontal VAS score ranging from 0 to 10 where 0 is considered the best disease activity (no disease activity) and 10 the worst (most disease activity). Higher scores indicate worse outcome.'}, {'measure': 'Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Participant/Parent Assessment of Overall Well-Being, at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. Participant/parent assessment of overall well-being was rated on an anchored 100 mm horizontal VAS score ranging from 0 to 10 where 0 is considered the best disease activity (no disease activity) and 10 the worst (most disease activity). Higher scores indicate worse outcome.'}, {'measure': 'Cohorts 1 and 3: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS-27) at Week 12', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The JADAS is used for assessment of disease activity, and it includes 4 measures: Physician global assessment of disease activity (VAS range: 0 to10; where 0= no activity and 10= maximum activity), parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and10= maximum activity), count of joints with active disease (range: 0 to 27; where 0= no activity and 27= maximum activity), and index of inflammation determined by hs-CRP or ESR (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity). The JADAS total score is calculated as the simple sum of the scores of its 4 components. The total score ranges from 0 to 57 where 0= no disease activity and 57= maximum disease activity. Higher scores indicate higher disease activity. Clinical JADAS-27 is without CRP or ESR component and score ranges from 0 to 47 where 0= no disease activity and 47= maximum disease activity.'}, {'measure': 'Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156', 'timeFrame': 'Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156', 'description': 'The JADAS is used for assessment of disease activity, and it includes 4 measures: Physician global assessment of disease activity (VAS range: 0 to10; where 0= no activity and 10= maximum activity), parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and10= maximum activity), count of joints with active disease (range: 0 to 27; where 0= no activity and 27= maximum activity), and index of inflammation determined by hs-CRP or ESR (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity). The JADAS total score is calculated as the simple sum of the scores of its 4 components. The total score ranges from 0 to 57 where 0= no disease activity and 57= maximum disease activity. Higher scores indicate higher disease activity. Clinical JADAS-27 is without CRP or ESR component and score ranges from 0 to 47 where 0= no disease activity and 47= maximum disease activity.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)', 'timeFrame': 'From the first administration of study treatment (Day 1) up to end of treatment period, maximum of 156 weeks for portions 1 and 2 and 96 weeks for portion 3', 'description': 'An adverse events (AEs) is any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. TEAEs are defined as AEs that develop or worsen during the on-treatment period \\[that is, from the time of first dose of study treatment up to 6 weeks after the last administration of the study treatment\\].'}, {'measure': 'Number of Participants With Local Site Reactions', 'timeFrame': 'From the first administration of study treatment (Day 1) up to end of treatment period, maximum of 156 weeks for portions 1 and 2 and 96 weeks for portion 3', 'description': 'Participants were observed for at least 30 minutes after each study treatment administration either on site or at home and any local reactions were noted in the diary regardless of being clinically significant.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ['Juvenile Idiopathic Arthritis']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo describe the pharmacokinetic (PK) profile of sarilumab in participants aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate treatment of this population\n\nSecondary Objective:\n\nTo describe the pharmacodynamic (PD) profile, the efficacy and the long-term safety of sarilumab in participants with pcJIA.', 'detailedDescription': 'For 73 participants enrolled in the dose-finding and second portions, the total study duration per participant was up to 166 weeks that consists of a 4- week screening, a 12-week core treatment phase, a 144-week extension phase, and a 6-week post-treatment follow-up. For 29 participants enrolled in the third portion, the total study duration per participant was up to 106 weeks that consists of a 4- week screening, a 12-week core treatment phase, a 84-week extension phase, and a 6-week post-treatment follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n* Male and female participants aged ≥2 and ≤17 years (or country specified age requirement) at the time of the screening visit.\n* Diagnosis of rheumatoid factor-negative or rheumatoid factor positive polyarticular Juvenile Idiopathic Arthritis (JIA) subtype or oligoarticular extended JIA subtype according to the International League of Associations for Rheumatology (ILAR) 2001 Juvenile Idiopathic Arthritis Classification Criteria with at least 5 active joints as per American College of Rheumatology (ACR) definition for "active arthritis" at Screening\n* Participant with an inadequate response to current treatment and considered as a candidate for a biologic disease modifying antirheumatic drug (DMARD) as per investigator\'s judgment\n\nExclusion criteria:\n\n* Body weight \\<10 kg or \\>60 kg for participants enrolled in the 3 ascending dose cohorts, then body weight \\<10 kg for participants subsequently enrolled at the selected dose-regimen.\n* If nonsteroidal anti-inflammatory drugs (NSAIDs) \\[including cyclo oxygenase-2 inhibitors (COX-2)\\] taken, dose stable for \\<2 weeks prior to the baseline visit and/or dosing prescribed outside of approved label.\n* If non-biologic DMARD taken, dose stable for \\<6 weeks prior to the baseline visit or at a dose exceeding the recommended dose as per local labeling.\n* If oral glucocorticoid taken, dose exceeding equivalent prednisone dose 0.5 mg/kg/day (or 30 mg/day) within 2 weeks prior to baseline.\n* Use of parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline.\n* Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.\n* Treatment with any biologic treatment for pcJIA within 5 half-lives prior to the first dose of sarilumab.\n* Treatment with a Janus kinase inhibitor within 4 weeks prior to the first dose of sarilumab; and treatment with growth hormone within 4 weeks prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).\n* Treatment with any investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline, whichever is longer.\n* Lipid lowering drug stable for less than 6 weeks prior to screening.\n* Exclusion related to tuberculosis (TB).\n* Exclusion criteria related to past or current infection other than tuberculosis.\n* Any live, attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, rubella vaccines. Killed or inactive vaccine may be permitted based on the Investigator\'s judgment.\n* Exclusion related to history of a systemic hypersensitivity reaction to any biologic drug and known hypersensitivity to any constituent of the product.\n* Laboratory abnormalities at the screening visit (identified by the central laboratory).\n* Pregnant or breast-feeding female adolescent participants.\n\nThe above information is not intended to contain all considerations relevant to a patient\'s potential participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT02776735', 'acronym': 'SKYPP', 'briefTitle': 'An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase', 'orgStudyIdInfo': {'id': 'DRI13925'}, 'secondaryIdInfos': [{'id': 'U1111-1177-3487', 'type': 'REGISTRY', 'domain': 'ICTRP'}, {'id': '2015-003999-79', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sarilumab', 'description': 'Participants received one of three ascending dose regimens of sarilumab by subcutaneous (SC) injection based on body weight. All the participants received the selected dose regimen once this was identified. Sarilumab was given during 12-week core treatment phase followed by an extension treatment phase (144 weeks for 73 participants enrolled in dose-finding and second portions and 84 weeks for approximately 29 participants enrolled in third portion)', 'interventionNames': ['Drug: Sarilumab']}], 'interventions': [{'name': 'Sarilumab', 'type': 'DRUG', 'otherNames': ['SAR153191 (REGN88)'], 'description': 'Pharmaceutical form:Solution Route of administration: Subcutaneous', 'armGroupLabels': ['Sarilumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles Site Number : 8400416", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': 'C1270AAN', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320060'}, {'zip': 'T4000AXL', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Investigational Site Number : 0320004', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'H3T1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Investigational Site Number : 1240112', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Concepción', 'state': 'Región del Biobío', 'country': 'Chile', 'facility': 'Investigational Site Number : 1520016', 'geoPoint': {'lat': -36.82699, 'lon': -73.04977}}, {'zip': '62500', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Investigational Site Number : 2030041', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '00029 HUS', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Investigational Site Number : 2460040', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Investigational Site Number : 2500040', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760064', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '28205', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760061', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '22081', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760062', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '53757', 'city': 'Sankt Augustin', 'country': 'Germany', 'facility': 'Investigational Site Number : 2760060', 'geoPoint': {'lat': 50.77538, 'lon': 7.197}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Investigational Site Number : 3800052', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '44620', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Investigational Site Number : 4840061', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Investigational Site Number : 4840060', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '3584 EA', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Investigational Site Number : 5280020', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '85-667', 'city': 'Bydgoszcz', 'state': 'Kuyavian-Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Investigational Site Number : 6160074', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '31-503', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Investigational Site Number : 6160073', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-093', 'city': 'Lublin', 'state': 'Lubusz Voivodeship', 'country': 'Poland', 'facility': 'Investigational Site Number : 6160070'}, {'zip': '91-738', 'city': 'Lodz', 'state': 'Lódzkie', 'country': 'Poland', 'facility': 'Investigational Site Number : 6160071', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '41-218', 'city': 'Sosnowiec', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Investigational Site Number : 6160072', 'geoPoint': {'lat': 50.28682, 'lon': 19.10385}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Investigational Site Number : 6430001', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117198', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Investigational Site Number : 6430062', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Investigational Site Number : 6430063', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '08950', 'city': 'Esplugues de Llobregat', 'state': 'Catalunya [Cataluña]', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240050', 'geoPoint': {'lat': 41.37732, 'lon': 2.08809}}, {'zip': '28046', 'city': 'Madrid', 'state': 'Madrid, Comunidad de', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240052', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240053', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240051', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'WC1N 3JH', 'city': 'London', 'state': 'London, City of', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260031', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'L12 2AP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260033', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}