[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614947":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":38,"locations":45,"responsibleParty":184,"collaborators":186,"id":189,"slug":37,"hasResults":190,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":37,"eligibilityCriteria":194,"healthyVolunteers":190,"sex":195,"minAge":196,"maxAge":37,"enrollmentInfo":197,"targetDuration":37,"studyType":200,"phases":201,"briefSummary":203,"conditions":204,"keywords":37,"overallStatus":48,"whyStopped":37,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo with prednisone taper",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Sarilumab 150 mg","EXPERIMENTAL","Participants will receive 150 mg sarilumab q2w with prednisone taper",[19],"Drug: Sarilumab",{"label":21,"type":16,"description":22,"interventionNames":23},"Sarilumab 200 mg","Participants will receive 200 mg sarilumab q2w with prednisone taper",[19],[25,32,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Sarilumab","Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous",[21],[31],"Kevzara®",{"type":26,"name":27,"description":28,"armGroupLabels":33,"otherNames":34},[15],[31],{"type":26,"name":9,"description":28,"armGroupLabels":36,"otherNames":37},[9],null,[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","Contact-US@sanofi.com",[46,59,69,78,87,96,105,114,124,134,144,153,163,173],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":37},"Denver Arthritis Clinic - Lowry- Site Number : 8400001","RECRUITING","Denver","Colorado","80230","United States",{"type":54,"coordinates":55},"Point",[56,57],-104.9847,39.73915,{"lat":57,"lon":56},{"facility":60,"status":48,"city":61,"state":62,"zip":63,"country":52,"cosmosGeoPoint":64,"geoPoint":68,"contacts":37},"Clinical Research of West Florida - Phase I Unit- Site Number : 8400024","Clearwater","Florida","33765",{"type":54,"coordinates":65},[66,67],-82.8001,27.96585,{"lat":67,"lon":66},{"facility":70,"status":48,"city":71,"state":62,"zip":72,"country":52,"cosmosGeoPoint":73,"geoPoint":77,"contacts":37},"Vitalia Medical Research - Margate- Site Number : 8400021","Margate","33063",{"type":54,"coordinates":74},[75,76],-80.20644,26.24453,{"lat":76,"lon":75},{"facility":79,"status":48,"city":80,"state":62,"zip":81,"country":52,"cosmosGeoPoint":82,"geoPoint":86,"contacts":37},"Florida Research Center- Site Number : 8400084","Miami","33174",{"type":54,"coordinates":83},[84,85],-80.19366,25.77427,{"lat":85,"lon":84},{"facility":88,"status":48,"city":89,"state":62,"zip":90,"country":52,"cosmosGeoPoint":91,"geoPoint":95,"contacts":37},"Innovia Research Center- Site Number : 8400029","Miramar","33027",{"type":54,"coordinates":92},[93,94],-80.23227,25.98731,{"lat":94,"lon":93},{"facility":97,"status":48,"city":98,"state":62,"zip":99,"country":52,"cosmosGeoPoint":100,"geoPoint":104,"contacts":37},"Discovery Clinical Research - Plantation- Site Number : 8400091","Plantation","33324",{"type":54,"coordinates":101},[102,103],-80.23184,26.13421,{"lat":103,"lon":102},{"facility":106,"status":48,"city":107,"state":62,"zip":108,"country":52,"cosmosGeoPoint":109,"geoPoint":113,"contacts":37},"Vantage Clinical Trials - Tampa- Site Number : 8400064","Tampa","33614",{"type":54,"coordinates":110},[111,112],-82.45843,27.94752,{"lat":112,"lon":111},{"facility":115,"status":48,"city":116,"state":117,"zip":118,"country":52,"cosmosGeoPoint":119,"geoPoint":123,"contacts":37},"Willow Rheumatology and Wellness- Site Number : 8400012","Willowbrook","Illinois","60527",{"type":54,"coordinates":120},[121,122],-87.93589,41.76975,{"lat":122,"lon":121},{"facility":125,"status":48,"city":126,"state":127,"zip":128,"country":52,"cosmosGeoPoint":129,"geoPoint":133,"contacts":37},"Inspire Santa Fe Medical Group- Site Number : 8400077","Santa Fe","New Mexico","87505",{"type":54,"coordinates":130},[131,132],-105.9378,35.68698,{"lat":132,"lon":131},{"facility":135,"status":48,"city":136,"state":137,"zip":138,"country":52,"cosmosGeoPoint":139,"geoPoint":143,"contacts":37},"Altoona Center for Clinical Research - Duncansville- Site Number : 8400018","Duncansville","Pennsylvania","16635",{"type":54,"coordinates":140},[141,142],-78.4339,40.42341,{"lat":142,"lon":141},{"facility":145,"status":48,"city":146,"state":137,"zip":147,"country":52,"cosmosGeoPoint":148,"geoPoint":152,"contacts":37},"Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013","Wyomissing","19610",{"type":54,"coordinates":149},[150,151],-75.96521,40.32954,{"lat":151,"lon":150},{"facility":154,"status":48,"city":155,"state":156,"zip":157,"country":52,"cosmosGeoPoint":158,"geoPoint":162,"contacts":37},"West Tennessee Research Institute- Site Number : 8400009","Jackson","Tennessee","38305",{"type":54,"coordinates":159},[160,161],-88.81395,35.61452,{"lat":161,"lon":160},{"facility":164,"status":48,"city":165,"state":166,"zip":167,"country":52,"cosmosGeoPoint":168,"geoPoint":172,"contacts":37},"TAD Clinical Research - Lufkin- Site Number : 8400069","Lufkin","Texas","75904",{"type":54,"coordinates":169},[170,171],-94.7291,31.33824,{"lat":171,"lon":170},{"facility":174,"status":48,"city":175,"state":176,"zip":177,"country":178,"cosmosGeoPoint":179,"geoPoint":183,"contacts":37},"Investigational Site Number : 1240003","Sherbrooke","Quebec","J1G 2E8","Canada",{"type":54,"coordinates":180},[181,182],-71.89908,45.40008,{"lat":182,"lon":181},{"type":185,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[187],{"name":188,"class":6},"Regeneron Pharmaceuticals","100614947",false,"NCT07286214","Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica","A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Each of Two Dose Levels of Sarilumab in Adults With Early Polymyalgia Rheumatica","Inclusion Criteria:\n\n* Adults ≥50 years with polymyalgia rheumatica according to the EULAR\u002FACR classification criteria\n* Meet criteria for newly diagnosed PMR (received ≤6 weeks of corticosteroids prior to randomization) or for early relapsing PMR (initiated corticosteroid treatment within last year, treated with prednisone ≥10 mg\u002Fday for ≥ 8 weeks, and experienced flare within prior 12 weeks while receiving ≥5 mg\u002Fd prednisone)\n* Participants must be willing and able to take prednisone of 15 mg\u002Fday at randomization\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n\nExclusion Criteria:\n\n* Diagnosis of Giant Cell Arteritis (GCA)\n* Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia\n* Inadequately treated hypothyroidism\n* Exclusion related to tuberculosis (TB), invasive opportunistic infections, recurrent or persistent infections including hepatitis B, C or HIV, recurrent herpes zoster or active herpes zoster\n* Patients with uncontrolled diabetes mellitus (HbA1c ≥9%)\n* Immunosuppressive therapies including systemic corticosteroids\n* Malignancy\n* Organ transplant recipient\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","ALL","50 Years",{"count":198,"type":199},300,"ESTIMATED","INTERVENTIONAL",[202],"PHASE4","This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week prednisone taper, is superior to placebo given with a 52-week prednisone taper in participants with early polymyalgia rheumatica (PMR) and to determine the safety and tolerability of the sarilumab regimens.\n\nThe study will consist of the following visits:\n\nVisit 1 (D-42 to D-1): Screening, Visit 2 (D1): Baseline, randomization, first study drug administration, Visit 3 to 12 (Week 2 to Week 52): Treatment period, Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.",[205],"Polymyalgia Rheumatica","2026-06-19",{"date":208,"type":209},"2026-06-23","ACTUAL",{"date":211,"type":209},"2026-05-12",{"date":213,"type":199},"2029-07-16",{"name":5,"class":6},14]