[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585964":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":23,"studyPopulation":23,"armGroups":33,"interventions":40,"overallOfficials":23,"centralContacts":45,"locations":51,"responsibleParty":280,"collaborators":23,"id":282,"slug":23,"hasResults":283,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":283,"sex":289,"minAge":290,"maxAge":23,"enrollmentInfo":291,"targetDuration":23,"studyType":294,"phases":295,"briefSummary":297,"conditions":298,"keywords":23,"overallStatus":54,"whyStopped":23,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":309},{"fullName":5,"class":6},"argenx","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants who achieve MSE of MG at any time within the first 16 weeks of treatment with efgartigimod PH20 SC","MSE (minimal symptom expression) is defined as an MG-ADL (Myasthenia Gravis Activities of Daily Living) total score of 0 or 1. The MG-ADL scale assesses MG symptoms and their effects on daily activities. The score varies between 0 and 24 (with 24 the most severe).","up to 16 weeks",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"Changes from baseline in MG-ADL total scores over time","The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The score varies between 0 and 24 (with 24 the most severe).","up to 51 weeks",{"measure":19,"description":20,"timeFrame":17},"Changes from baseline in MG-QOL-15r total scores over time","The MG-QoL15r (Myasthenia Gravis Quality of Life 15-item scale revised) questionnaire is a patient-reported instrument that measures the impact of MG symptoms on Quality of Life. The score varies between 0 and 30 (with 30 the lowest quality of life).",{"measure":22,"description":23,"timeFrame":24},"Proportion of participants who are administered systemic corticosteroid therapy as background add-on therapy throughout the study",null,"up to 55 weeks",{"measure":26,"description":23,"timeFrame":24},"Incidence of adverse events, serious adverse events and adverse events leading to study drug discontinuation",{"allocation":28,"interventionModel":29,"interventionModelDescription":23,"primaryPurpose":30,"observationalModel":23,"timePerspective":23,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":23,"whoMasked":23},"NONE",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"Efgartigimod PH20 SC","EXPERIMENTAL","Participants receiving efgartigimod PH20 SC",[39],"Biological: Efgartigimod PH20 SC",[41],{"type":42,"name":35,"description":43,"armGroupLabels":44,"otherNames":23},"BIOLOGICAL","Subcutaneous injection of efgartigimod PH20 SC",[35],[46],{"name":47,"role":48,"phone":49,"phoneExt":23,"email":50},"Sabine Coppieters, MD","CONTACT","857-350-4834","clinicaltrials@argenx.com",[52,69,81,94,106,118,130,142,154,167,180,189,202,215,228,241,254,267],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)","RECRUITING","La Jolla","California","92037","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-117.2742,32.84727,{"lat":64,"lon":63},[67],{"name":68,"role":48,"phone":49,"phoneExt":23,"email":50},"Wali Qayoumi, MD",{"facility":70,"status":54,"city":71,"state":56,"zip":72,"country":58,"countryCode":59,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Samir Macwan, M.D., Inc. (S corporation)","Rancho Mirage","92270",{"type":61,"coordinates":74},[75,76],-116.41279,33.73974,{"lat":76,"lon":75},[79],{"name":80,"role":48,"phone":49,"phoneExt":23,"email":50},"Samir Macwan, MD",{"facility":82,"status":54,"city":83,"state":84,"zip":85,"country":58,"countryCode":59,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"EZR Research","Boca Raton","Florida","33486",{"type":61,"coordinates":87},[88,89],-80.0831,26.35869,{"lat":89,"lon":88},[92],{"name":93,"role":48,"phone":49,"phoneExt":23,"email":50},"Patricio Espinosa Prado, MD",{"facility":95,"status":54,"city":96,"state":84,"zip":97,"country":58,"countryCode":59,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"University of Florida Jacksonville","Jacksonville","32209",{"type":61,"coordinates":99},[100,101],-81.65565,30.33218,{"lat":101,"lon":100},[104],{"name":105,"role":48,"phone":49,"phoneExt":23,"email":50},"Michael Pulley, MD",{"facility":107,"status":54,"city":108,"state":84,"zip":109,"country":58,"countryCode":59,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Visionary Investigators Network","Miami","33133",{"type":61,"coordinates":111},[112,113],-80.19366,25.77427,{"lat":113,"lon":112},[116],{"name":117,"role":48,"phone":49,"phoneExt":23,"email":50},"Andrew Lerman, MD",{"facility":119,"status":54,"city":120,"state":84,"zip":121,"country":58,"countryCode":59,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"University of California Irvine","Orange","92868",{"type":61,"coordinates":123},[124,125],-85.02492,30.2277,{"lat":125,"lon":124},[128],{"name":129,"role":48,"phone":49,"phoneExt":23,"email":50},"Ali Habib, MD",{"facility":131,"status":54,"city":132,"state":84,"zip":133,"country":58,"countryCode":59,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Medsol Clinical Research Center Inc","Port Charlotte","33952",{"type":61,"coordinates":135},[136,137],-82.09064,26.97617,{"lat":137,"lon":136},[140],{"name":141,"role":48,"phone":49,"phoneExt":23,"email":50},"George Li, MD",{"facility":143,"status":54,"city":144,"state":84,"zip":145,"country":58,"countryCode":59,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Baycare Medical Group","St. Petersburg","33705",{"type":61,"coordinates":147},[148,149],-82.67927,27.77086,{"lat":149,"lon":148},[152],{"name":153,"role":48,"phone":49,"phoneExt":23,"email":50},"Michael Rosario-Prieto, MD",{"facility":155,"status":54,"city":156,"state":157,"zip":158,"country":58,"countryCode":59,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Emory Brain Health Center","Atlanta","Georgia","30329",{"type":61,"coordinates":160},[161,162],-84.38798,33.749,{"lat":162,"lon":161},[165],{"name":166,"role":48,"phone":49,"phoneExt":23,"email":50},"Vita Kesner, MD",{"facility":168,"status":54,"city":169,"state":170,"zip":171,"country":58,"countryCode":59,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"The Queen's Medical Center - West Oahu","Honolulu","Hawaii","96813",{"type":61,"coordinates":173},[174,175],-157.85833,21.30694,{"lat":175,"lon":174},[178],{"name":179,"role":48,"phone":49,"phoneExt":23,"email":50},"Jeffrey Miles, MD",{"facility":181,"status":54,"city":169,"state":170,"zip":182,"country":58,"countryCode":59,"cosmosGeoPoint":183,"geoPoint":185,"contacts":186},"Hawaii Pacific Neuroscience","96817",{"type":61,"coordinates":184},[174,175],{"lat":175,"lon":174},[187],{"name":188,"role":48,"phone":49,"phoneExt":23,"email":50},"Natalia Gonzalez Caldito, MD",{"facility":190,"status":54,"city":191,"state":192,"zip":193,"country":58,"countryCode":59,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"HSHS Medical Group","O'Fallon","Illinois","62269",{"type":61,"coordinates":195},[196,197],-89.91121,38.59227,{"lat":197,"lon":196},[200],{"name":201,"role":48,"phone":49,"phoneExt":23,"email":50},"Raghav Govindarajan, MD",{"facility":203,"status":54,"city":204,"state":205,"zip":206,"country":58,"countryCode":59,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"UMass Memorial Medical Center","Worcester","Massachusetts","01655",{"type":61,"coordinates":208},[209,210],-71.80229,42.26259,{"lat":210,"lon":209},[213],{"name":214,"role":48,"phone":49,"phoneExt":23,"email":50},"Shivkumar Bhadola, MD",{"facility":216,"status":54,"city":217,"state":218,"zip":219,"country":58,"countryCode":59,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Henry Ford Health System","Detroit","Michigan","48202",{"type":61,"coordinates":221},[222,223],-83.04575,42.33143,{"lat":223,"lon":222},[226],{"name":227,"role":48,"phone":49,"phoneExt":23,"email":50},"Kavita Grover, MD",{"facility":229,"status":54,"city":230,"state":231,"zip":232,"country":58,"countryCode":59,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":61,"coordinates":234},[235,236],-81.69541,41.4995,{"lat":236,"lon":235},[239],{"name":240,"role":48,"phone":49,"phoneExt":23,"email":50},"Yuebing Li, MD",{"facility":242,"status":54,"city":243,"state":244,"zip":245,"country":58,"countryCode":59,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"Erlanger Neuroscience Institute","Chattanooga","Tennessee","37403",{"type":61,"coordinates":247},[248,249],-85.30968,35.04563,{"lat":249,"lon":248},[252],{"name":253,"role":48,"phone":49,"phoneExt":23,"email":50},"Joshua Alpers, MD",{"facility":255,"status":54,"city":256,"state":257,"zip":258,"country":58,"countryCode":59,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"Central Texas Neurology Consultants - Elligo","Round Rock","Texas","78681",{"type":61,"coordinates":260},[261,262],-97.6789,30.50826,{"lat":262,"lon":261},[265],{"name":266,"role":48,"phone":49,"phoneExt":23,"email":50},"Adam Horvit, MD",{"facility":268,"status":54,"city":269,"state":270,"zip":271,"country":58,"countryCode":59,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"Center for Neurological Disorders - Greenfield","Greenfield","Wisconsin","53228-1321",{"type":61,"coordinates":273},[274,275],-88.01259,42.9614,{"lat":275,"lon":274},[278],{"name":279,"role":48,"phone":49,"phoneExt":23,"email":50},"Bhupendra Khatri, MD",{"type":281,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100585964",false,"NCT06909214","A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)","A Phase 4, Open-Label, Prospective, Single-Group, Multicenter Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adult Participants With New-Onset Generalized Myasthenia Gravis","ADAPT-EARLY","Inclusion Criteria:\n\n* Is at least 18 years when signing the ICF\n* Has been diagnosed with gMG of MGFA class II, III, or IV\n* Is seropositive for AChR-Ab\n* Is treatment-naive for gMG or has been administered AChEI for the treatment of gMG\n* Had onset of generalized MG signs and\u002For symptoms within 12 months before screening; candidates who also had onset of ocular MG signs and\u002For symptoms within 24 months before screening may be enrolled in the study\n* Has an MG-ADL score ≥5\n\nExclusion Criteria:\n\n* gMG diagnosis of MGFA class I or V\n* Underwent a thymectomy prior to screening, except thymectomy for treatment of nonmalignant thymoma prior to the gMG diagnosis\n* Prior or current use of any of any systemic corticosteroid therapy or nonsteroidal immunosuppressive therapy for the treatment of gMG","ALL","18 Years",{"count":292,"type":293},30,"ESTIMATED","INTERVENTIONAL",[296],"PHASE4","The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and\u002For symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.",[299],"New Onset Generalized Myasthenia Gravis (gMG)","2026-03-09",{"date":302,"type":303},"2026-03-10","ACTUAL",{"date":305,"type":303},"2025-04-17",{"date":307,"type":293},"2027-05",{"name":5,"class":6},18]