[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614947":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":38,"locations":45,"responsibleParty":186,"collaborators":188,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":37,"eligibilityCriteria":197,"healthyVolunteers":193,"sex":198,"minAge":199,"maxAge":37,"enrollmentInfo":200,"targetDuration":37,"studyType":203,"phases":204,"briefSummary":206,"conditions":207,"keywords":37,"overallStatus":48,"whyStopped":37,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},{"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",[46,60,70,79,88,97,106,115,125,135,145,154,164,174],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":37},"Denver Arthritis Clinic - Lowry- Site Number : 8400001","RECRUITING","Denver","Colorado","80230","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-104.9847,39.73915,{"lat":58,"lon":57},{"facility":61,"status":48,"city":62,"state":63,"zip":64,"country":52,"countryCode":53,"cosmosGeoPoint":65,"geoPoint":69,"contacts":37},"Clinical Research of West Florida - Phase I Unit- Site Number : 8400024","Clearwater","Florida","33765",{"type":55,"coordinates":66},[67,68],-82.8001,27.96585,{"lat":68,"lon":67},{"facility":71,"status":48,"city":72,"state":63,"zip":73,"country":52,"countryCode":53,"cosmosGeoPoint":74,"geoPoint":78,"contacts":37},"Vitalia Medical Research - Margate- Site Number : 8400021","Margate","33063",{"type":55,"coordinates":75},[76,77],-80.20644,26.24453,{"lat":77,"lon":76},{"facility":80,"status":48,"city":81,"state":63,"zip":82,"country":52,"countryCode":53,"cosmosGeoPoint":83,"geoPoint":87,"contacts":37},"Florida Research Center- Site Number : 8400084","Miami","33174",{"type":55,"coordinates":84},[85,86],-80.19366,25.77427,{"lat":86,"lon":85},{"facility":89,"status":48,"city":90,"state":63,"zip":91,"country":52,"countryCode":53,"cosmosGeoPoint":92,"geoPoint":96,"contacts":37},"Innovia Research Center- Site Number : 8400029","Miramar","33027",{"type":55,"coordinates":93},[94,95],-80.23227,25.98731,{"lat":95,"lon":94},{"facility":98,"status":48,"city":99,"state":63,"zip":100,"country":52,"countryCode":53,"cosmosGeoPoint":101,"geoPoint":105,"contacts":37},"Discovery Clinical Research - Plantation- Site Number : 8400091","Plantation","33324",{"type":55,"coordinates":102},[103,104],-80.23184,26.13421,{"lat":104,"lon":103},{"facility":107,"status":48,"city":108,"state":63,"zip":109,"country":52,"countryCode":53,"cosmosGeoPoint":110,"geoPoint":114,"contacts":37},"Vantage Clinical Trials - Tampa- Site Number : 8400064","Tampa","33614",{"type":55,"coordinates":111},[112,113],-82.45843,27.94752,{"lat":113,"lon":112},{"facility":116,"status":48,"city":117,"state":118,"zip":119,"country":52,"countryCode":53,"cosmosGeoPoint":120,"geoPoint":124,"contacts":37},"Willow Rheumatology and Wellness- Site Number : 8400012","Willowbrook","Illinois","60527",{"type":55,"coordinates":121},[122,123],-87.93589,41.76975,{"lat":123,"lon":122},{"facility":126,"status":48,"city":127,"state":128,"zip":129,"country":52,"countryCode":53,"cosmosGeoPoint":130,"geoPoint":134,"contacts":37},"Inspire Santa Fe Medical Group- Site Number : 8400077","Santa Fe","New Mexico","87505",{"type":55,"coordinates":131},[132,133],-105.9378,35.68698,{"lat":133,"lon":132},{"facility":136,"status":48,"city":137,"state":138,"zip":139,"country":52,"countryCode":53,"cosmosGeoPoint":140,"geoPoint":144,"contacts":37},"Altoona Center for Clinical Research - Duncansville- Site Number : 8400018","Duncansville","Pennsylvania","16635",{"type":55,"coordinates":141},[142,143],-78.4339,40.42341,{"lat":143,"lon":142},{"facility":146,"status":48,"city":147,"state":138,"zip":148,"country":52,"countryCode":53,"cosmosGeoPoint":149,"geoPoint":153,"contacts":37},"Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013","Wyomissing","19610",{"type":55,"coordinates":150},[151,152],-75.96521,40.32954,{"lat":152,"lon":151},{"facility":155,"status":48,"city":156,"state":157,"zip":158,"country":52,"countryCode":53,"cosmosGeoPoint":159,"geoPoint":163,"contacts":37},"West Tennessee Research Institute- Site Number : 8400009","Jackson","Tennessee","38305",{"type":55,"coordinates":160},[161,162],-88.81395,35.61452,{"lat":162,"lon":161},{"facility":165,"status":48,"city":166,"state":167,"zip":168,"country":52,"countryCode":53,"cosmosGeoPoint":169,"geoPoint":173,"contacts":37},"TAD Clinical Research - Lufkin- Site Number : 8400069","Lufkin","Texas","75904",{"type":55,"coordinates":170},[171,172],-94.7291,31.33824,{"lat":172,"lon":171},{"facility":175,"status":48,"city":176,"state":177,"zip":178,"country":179,"countryCode":180,"cosmosGeoPoint":181,"geoPoint":185,"contacts":37},"Investigational Site Number : 1240003","Sherbrooke","Quebec","J1G 2E8","Canada","CA",{"type":55,"coordinates":182},[183,184],-71.89908,45.40008,{"lat":184,"lon":183},{"type":187,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[189],{"name":190,"class":6},"Regeneron Pharmaceuticals","100614947","phase-4-sarilumab-efficacy-and-safety-in-adults-with-early-polymyalgia-rheumatica-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":201,"type":202},300,"ESTIMATED","INTERVENTIONAL",[205],"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.",[208],"Polymyalgia Rheumatica","2026-06-19",{"date":211,"type":212},"2026-06-23","ACTUAL",{"date":214,"type":212},"2026-05-12",{"date":216,"type":202},"2029-07-16",{"name":5,"class":6},14]