Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-02 @ 8:17 AM
Study NCT ID:
NCT04008069
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2019-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012507', 'term': 'Sarcoidosis'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592401', 'term': 'sarilumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mbake13@stanford.edu', 'phone': '650- 498-4528', 'title': 'Dr. Matthew C. Baker, Principal Investigator', 'organization': 'Stanford University, School of Medicine, Immunology & Rheumatology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 28 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 9, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Transaminitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prolonged neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcers aphthous oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral vision defective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervical radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kappa light chain analysis increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herniated disc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Creatinine kinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in (r) hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol rehabilitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Without Sarcoidosis Flare (Flare-Free Survival)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16 to Week 28', 'description': 'The primary outcome was flare-free survival of sarilumab-treated patients compared to placebo-treated controls. Patients will be considered to have flared if they receive rescue medication including increased glucocorticoids, or if they discontinue the study treatment in order to start a different therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Assessed in participants in the randomized-withdrawal period'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92.1', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '113', 'spread': '14.9', 'groupId': 'OG001'}, {'value': '95.9', 'spread': '17.3', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.69', 'spread': '4.89', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': 'NA', 'comment': 'Not calculable for n of 1', 'groupId': 'OG001'}, {'value': '-1.38', 'spread': '4.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 16', 'description': 'FVC is a pulmonary function test, and is defined as the volume of air that can forcibly be blown out after taking a full breath. FVC% predicted is defined as FVC% of the patient divided by the average FVC% in the population for any person of similar age, sex and body composition.', 'unitOfMeasure': 'FVC % predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92.6', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '90', 'spread': 'NA', 'comment': 'Not calculable for n of 1', 'groupId': 'OG001'}, {'value': '93.5', 'spread': '22.8', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.8', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '-18.4', 'spread': '28.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and week 16', 'description': 'DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% predicted is defined as DLCO% of the patient divided by the average DLCO% in the population for any person of similar age, sex and body composition.', 'unitOfMeasure': 'DLCO % predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Change in Pulmonary Function (FEV1) Percent Predicted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '89.0', 'spread': '19.86', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '86.0', 'spread': '18.25', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 16', 'description': 'FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.', 'unitOfMeasure': 'FEV1 % predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were collected during the open-label portion of the study only'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Extrapulmonary Physician Organ Severity Tool (ePOST) Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.53', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '7.50', 'spread': '4.95', 'groupId': 'OG001'}, {'value': '2.38', 'spread': '1.85', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '-0.75', 'spread': '0.89', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': 'NA', 'comment': 'Not calculable for n of 1', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '1.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Physician and patient assessments assessed using the extrapulmonary physician organ severity tool (ePOST).\n\nScore Description:\n\n0: Not affected\n\n1. Slight\n2. Mild\n3. Moderate\n4. Moderate to severe\n5. Severe\n6. Very Severe 17 organ domains were rated and summed to create a total score (range 0-102, higher scores correspond with more severity).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physician Disease Activity Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.0', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '38.5', 'spread': '20.5', 'groupId': 'OG001'}, {'value': '45.3', 'spread': '13.9', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-22.8', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '-13.0', 'spread': '5.66', 'groupId': 'OG001'}, {'value': '-35.6', 'spread': '11.3', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-31.8', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '-21.0', 'spread': 'NA', 'comment': 'Not calculable for n of 1', 'groupId': 'OG001'}, {'value': '-34.0', 'spread': '13.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16, and week 28', 'description': "Physician rates patient's disease on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state.", 'unitOfMeasure': 'units on a scale (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Disease Activity Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.1', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '9.19', 'groupId': 'OG001'}, {'value': '27.4', 'spread': '23.6', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.86', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '7.78', 'groupId': 'OG001'}, {'value': '-11.1', 'spread': '19.9', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '34.4', 'groupId': 'OG000'}, {'value': '-5.00', 'spread': 'NA', 'comment': 'Not calculable for n of 1', 'groupId': 'OG001'}, {'value': '-2.50', 'spread': '39.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Patient rates their disease on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state.', 'unitOfMeasure': 'units on a scale (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FACIT-F Score (Fatigue Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.1', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '51.0', 'spread': '0', 'groupId': 'OG001'}, {'value': '37.9', 'spread': '12.4', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.86', 'spread': '9.58', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '5.62', 'spread': '9.64', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.00', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'Not calculable for n of 1', 'groupId': 'OG001'}, {'value': '6.25', 'spread': '14.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'FACIT-F score\n\nTotal score range: 0-52, lower scores correspond with more fatigue.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Tender and Swollen Joints Per 68/66 Joint Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline - tender joints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Baseline - swollen joints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 - tender joints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 - swollen joints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 - tender joints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 - swollen joints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'The 66/68 Joint Count evaluates 68 joints for tenderness and pain with movement and 66 joints for swelling (hip joints can be evaluated for tenderness only, not for swelling.\n\nJoint evaluation score:\n\n0: Absent\n\n1: Present 9: Not applicable', 'unitOfMeasure': 'joints', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who presented with inflammatory arthritis and with available data at each respective time point are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Sarcoidosis Activity and Severity Index for Cutaneous Sarcoidosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.7', 'spread': '9.29', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '10.61', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.7', 'spread': '15.50', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '11.31', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '11.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Sarcoidosis Activity and Severity Index evaluates 7 parameters on a 0 to 4 scale, summed for an overall scale score of 0 to 28 (higher values indicate higher activity/severity).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who presented with cutaneous sarcoidosis and with available data at each respective time point.'}, {'type': 'SECONDARY', 'title': 'Change in Size of Sarcoidosis Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'timeFrame': 'Baseline, week 16, and week 28', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Angiotensin Converting Enzyme', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.4', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '63.0', 'spread': '7.07', 'groupId': 'OG001'}, {'value': '32.6', 'spread': '26.6', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.1', 'spread': '24.6', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '51.6', 'groupId': 'OG001'}, {'value': '8.12', 'spread': '11.9', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.17', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '14.0', 'spread': 'NA', 'comment': 'Not calculable for n of 1', 'groupId': 'OG001'}, {'value': '5.80', 'spread': '22.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'ACE is a serum marker that is increased in sarcoidosis. ACE is produced by epithelioid cells that are derived from recently-activated macrophages in granulomas; thus, ACE is an appropriate representative of whole-body granuloma.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.42', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '0.53', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'Not calculable for n of 1', 'groupId': 'OG001'}, {'value': '-0.24', 'spread': '0.61', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16, and week 28', 'description': "CRP is a protein made by the liver. The level of CRP increases when there's inflammation in the body.", 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.33', 'spread': '5.65', 'groupId': 'OG000'}, {'value': '9.50', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '7.38', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '6.51', 'groupId': 'OG000'}, {'value': '-7.00', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '-3.43', 'spread': '6.68', 'groupId': 'OG002'}]}]}, {'title': 'Change at week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '-6.00', 'spread': 'NA', 'comment': 'Not calculable for n of 1', 'groupId': 'OG001'}, {'value': '-1.20', 'spread': '7.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'ESR is the rate at which red blood cells in anticoagulated whole blood descend in a standardized tube over a period of one hour.', 'unitOfMeasure': 'cells per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Change in Prednisone Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'timeFrame': 'Baseline, week 16, and week 28', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Alanine Aminotransferase (ALT) Outside Normal Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Normal range as calculated by the local laboratory.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Aspartate Aminotransferase (AST) Outside Normal Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Normal range as calculated by the local laboratory.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serum Creatinine Outside Normal Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Normal range as calculated by the local laboratory.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Urine Protein Outside Normal Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab every two weeks for 12 weeks.'}, {'id': 'OG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Normal range as calculated by the local laboratory.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data at each respective time point are included in the analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open-Label Sarilumab (Pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab (200 mg administered subcutaneously) every two weeks for 16 weeks.'}, {'id': 'FG001', 'title': 'Double-Blind Sarilumab (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized to receive sarilumab (200 mg administered subcutaneously) every two weeks for 12 weeks.'}, {'id': 'FG002', 'title': 'Double-Blind Placebo (Post-randomization)', 'description': 'After completing the open-label period, participants are randomized receive placebo every two weeks for 12 weeks.'}], 'periods': [{'title': 'Open-Label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Completed Treatment up to Week 16', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Randomized-Withdrawal Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Completed Treatment With Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Sixteen participants were screened, fifteen met eligibility criteria and were allocated to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants who enter the study, to receive open-label sarilumab every two weeks for 16 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '9.51', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 50 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '≥ 50 Years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-19', 'size': 723608, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-11T15:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Study doctor and personnel will not know whether you are assigned to the sarilumab group or the placebo group after Week 16.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All subjects will all receive sarilumab 200 mg subcutaneously every two weeks for the first 16 weeks of the study. At Week 16, those patients who were able to successfully taper off of prednisone will then be assigned randomly to receive either sarilumab 200 mg subcutaneously every two weeks (study drug) or placebo subcutaneously for an additional 12 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2019-06-25', 'resultsFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-04', 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Without Sarcoidosis Flare (Flare-Free Survival)', 'timeFrame': 'Week 16 to Week 28', 'description': 'The primary outcome was flare-free survival of sarilumab-treated patients compared to placebo-treated controls. Patients will be considered to have flared if they receive rescue medication including increased glucocorticoids, or if they discontinue the study treatment in order to start a different therapy.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted', 'timeFrame': 'Baseline and week 16', 'description': 'FVC is a pulmonary function test, and is defined as the volume of air that can forcibly be blown out after taking a full breath. FVC% predicted is defined as FVC% of the patient divided by the average FVC% in the population for any person of similar age, sex and body composition.'}, {'measure': 'Change From Baseline in Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted', 'timeFrame': 'Baseline, and week 16', 'description': 'DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% predicted is defined as DLCO% of the patient divided by the average DLCO% in the population for any person of similar age, sex and body composition.'}, {'measure': 'Change in Pulmonary Function (FEV1) Percent Predicted', 'timeFrame': 'Baseline and week 16', 'description': 'FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.'}, {'measure': 'Change From Baseline in Extrapulmonary Physician Organ Severity Tool (ePOST) Scale Score', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Physician and patient assessments assessed using the extrapulmonary physician organ severity tool (ePOST).\n\nScore Description:\n\n0: Not affected\n\n1. Slight\n2. Mild\n3. Moderate\n4. Moderate to severe\n5. Severe\n6. Very Severe 17 organ domains were rated and summed to create a total score (range 0-102, higher scores correspond with more severity).'}, {'measure': 'Change From Baseline in Physician Disease Activity Visual Analogue Scale (VAS)', 'timeFrame': 'Baseline, week 16, and week 28', 'description': "Physician rates patient's disease on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state."}, {'measure': 'Change From Baseline in Patient Disease Activity Visual Analogue Scale (VAS)', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Patient rates their disease on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state.'}, {'measure': 'Change From Baseline in FACIT-F Score (Fatigue Scale)', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'FACIT-F score\n\nTotal score range: 0-52, lower scores correspond with more fatigue.'}, {'measure': 'Number of Tender and Swollen Joints Per 68/66 Joint Evaluation', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'The 66/68 Joint Count evaluates 68 joints for tenderness and pain with movement and 66 joints for swelling (hip joints can be evaluated for tenderness only, not for swelling.\n\nJoint evaluation score:\n\n0: Absent\n\n1: Present 9: Not applicable'}, {'measure': 'Sarcoidosis Activity and Severity Index for Cutaneous Sarcoidosis', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Sarcoidosis Activity and Severity Index evaluates 7 parameters on a 0 to 4 scale, summed for an overall scale score of 0 to 28 (higher values indicate higher activity/severity).'}, {'measure': 'Change in Size of Sarcoidosis Lesions', 'timeFrame': 'Baseline, week 16, and week 28'}, {'measure': 'Change From Baseline in Serum Angiotensin Converting Enzyme', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'ACE is a serum marker that is increased in sarcoidosis. ACE is produced by epithelioid cells that are derived from recently-activated macrophages in granulomas; thus, ACE is an appropriate representative of whole-body granuloma.'}, {'measure': 'Change From Baseline in Serum C-Reactive Protein (CRP)', 'timeFrame': 'Baseline, week 16, and week 28', 'description': "CRP is a protein made by the liver. The level of CRP increases when there's inflammation in the body."}, {'measure': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'ESR is the rate at which red blood cells in anticoagulated whole blood descend in a standardized tube over a period of one hour.'}, {'measure': 'Change in Prednisone Dose', 'timeFrame': 'Baseline, week 16, and week 28'}, {'measure': 'Number of Participants With Alanine Aminotransferase (ALT) Outside Normal Range', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Normal range as calculated by the local laboratory.'}, {'measure': 'Number of Participants With Aspartate Aminotransferase (AST) Outside Normal Range', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Normal range as calculated by the local laboratory.'}, {'measure': 'Number of Participants With Serum Creatinine Outside Normal Range', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Normal range as calculated by the local laboratory.'}, {'measure': 'Number of Participants With Urine Protein Outside Normal Range', 'timeFrame': 'Baseline, week 16, and week 28', 'description': 'Normal range as calculated by the local laboratory.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glucocorticoid-dependent'], 'conditions': ['Sarcoidosis']}, 'referencesModule': {'references': [{'pmid': '37471590', 'type': 'DERIVED', 'citation': 'Baker MC, Horomanski A, Wang Y, Liu Y, Parsafar S, Fairchild R, Mooney JJ, Raj R, Witteles R, Genovese MC. A double-blind, placebo-controlled, randomized withdrawal trial of sarilumab for the treatment of glucocorticoid-dependent sarcoidosis. Rheumatology (Oxford). 2024 May 2;63(5):1297-1304. doi: 10.1093/rheumatology/kead373.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness and the safety of sarilumab in patients with glucocorticoid-dependent sarcoidosis.', 'detailedDescription': 'The purpose of this study is to compare the effectivness and the safety of sarilumab in patients with glucocorticoid-dependent sarcoidosis. To demonstrate that sarilumab treatment will be effective for inducing and maintaining glucocorticoid-free remission in male or female patients with biopsy proven active, glucocorticoid-dependent sarcoidosis affecting the lungs, lymph nodes, liver, kidneys, spleen, bone, soft tissues, skin, and/or eyes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Biopsy proven non-caseating granulomas consistent with sarcoidosis\n* negative infectious studies including AFB and fungal stains, and with compatible clinical and/or radiographic manifestations of sarcoidosis.\n* Involvement of the lungs (stage II or III pulmonary sarcoidosis), lymph nodes, liver, kidneys, spleen, bone, soft tissues, skin, and/or eyes.\n* At least one active manifestation, defined by the need for ongoing glucocorticoid treatment to control a sign or symptom of sarcoidosis, which requires treatment with prednisone (or equivalent corticosteroid) ≥ 10 mg and ≤ 60 mg daily (i.e. glucocorticoid dependence), with stable dosing for ≥ 28 days prior to baseline.\n* patients taking a glucocorticoid other than prednisone, will be changed to prednisone at the equivalent dose and take this daily for ≥ 14 days prior to baseline.\n* DMARDs including methotrexate, leflunomide, azathioprine, mycophenolate mofetil, and/or anti-malarials (i.e. hydroxychloroquine) permitted must be stable for ≥ 28 days prior to baseline and remain stable during follow-up.\n\nExclusion Criteria:\n\n* Stage IV pulmonary sarcoidosis.\n* Central nervous system sarcoidosis.\n* Cardiac sarcoidosis.\n* Prior treatment with an anti-IL-6 therapy.\n* Treatment with a biologic agent including rituximab, belimumab, TNF inhibitors, abatacept, or IL-17 inhibitors administered within 28 days prior to baseline (6 months for rituximab).\n* Treatment with cyclophosphamide within 3 months prior to baseline.\n* Treatment with prednisone \\< 10 mg or \\> 60 mg daily.\n* Known hypersensitivity or allergy to the study drug.\n* History of, or current, inflammatory or autoimmune disease other than sarcoidosis which would present a safety issue or confound interpretation of the data.\n* Prior or current history of other significant concomitant illness that, according to the investigator's judgment, would adversely affect the patient's participation in the study. These include, but are not limited to, cardiovascular (including stage III or IV cardiac failure according to the New York Heart Association classification), neurological (including demyelinating disease), active infectious diseases, or history of diverticulitis or gastrointestinal perforation.\n* Patients currently pregnant or breast-feeding.\n* Women of childbearing potential (WOCBP) who are unwilling to utilize adequate contraception and unwilling to not become pregnant during the full course of the study (must be willing to be tested for pregnancy). Adequate contraceptive measures include oral contraceptives (continuous use, as per prescription, for 2 or more cycles prior to screening), intrauterine devices, contraceptive sponges, condoms or diaphragms plus foam, or jelly, or surgical procedures such as bilateral tubal ligation or vasectomy in partner.\n* Administration of a live/attenuated vaccine within 30 days.\n* Evidence of active tuberculosis, HIV, or hepatitis B or C infection.\n* History of cancer other than non-melanoma skin cancer.\n* Patients with any of the following laboratory abnormalities at the screening visit: hemoglobin \\<8.5 g/dL, white blood cells \\<3000/mm3, neutrophils \\<2000/mm3, platelet count \\<150,000 cells/mm3, aspartate aminotransferase (AST) or ALT \\>1.5 x ULN, and/or bilirubin (total) above the upper limit of normal (unless Gilbert's disease has been determined by genetic testing and documented).\n* Presence of severe uncontrolled hypercholesterolemia (\\>350 mg/dL, 9.1 mmol/L) or hypertriglyceridemia (\\>500 mg/dL, 5.6 mmol/L) at screening or baseline.\n* Patients with calculated creatinine clearance \\<30 mL/minute (using Cockroft-Gault formula).\n* History of alcohol or drug abuse within 5 years prior to the screening visit.\n* Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first investigational medicinal product (IMP) administration, whichever is longer.\n* Any patient who has had surgery within 4 weeks prior to the screening visit or with planned surgery during the course of the study."}, 'identificationModule': {'nctId': 'NCT04008069', 'briefTitle': 'Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Phase II, Single-Site, Double-Blind, Placebo-Controlled Randomized Withdrawal Study Assessing the Efficacy and Safety of Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis', 'orgStudyIdInfo': {'id': '48375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-Label Sarilumab (pre-randomization)', 'description': 'On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.', 'interventionNames': ['Drug: Sarilumab']}, {'type': 'EXPERIMENTAL', 'label': 'Double-Blind Sarilumab (post-randomization)', 'description': 'After completing the open-label period, participants are randomized in blinded fashion to receive sarilumab every two weeks for 12 weeks.', 'interventionNames': ['Drug: Sarilumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Double-Blind Placebo (post-randomization)', 'description': 'After completing the open-label period, participants are randomized in blinded fashion to receive placebo every two weeks for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sarilumab', 'type': 'DRUG', 'otherNames': ['Kevzara'], 'description': 'Sarilumab 200 mg administered subcutaneously', 'armGroupLabels': ['Double-Blind Sarilumab (post-randomization)', 'Open-Label Sarilumab (pre-randomization)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered subcutaneously', 'armGroupLabels': ['Double-Blind Placebo (post-randomization)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Matthew Baker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Matthew C. Baker', 'investigatorAffiliation': 'Stanford University'}}}}