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A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants with Active Idiopathic Inflammatory Myopathy.

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研究单位: [1]argenx [2]Neuromuscular Research Center,Phoenix,Arizona,United States,85028 [3]HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology,Scottsdale,Arizona,United States,85251 [4]Attune Health Research, Inc,Beverly Hills,California,United States,90039 [5]University of Southern California Norris Comprehensive Cancer Center,Los Angeles,California,United States,90033 [6]University Of California - Los Angeles,Los Angeles,California,United States,90095-1670 [7]Profound Research LLC - Oceanside,Oceanside,California,United States,92056 [8]University of California, Irvine,Orange,California,United States,92868 [9]Stanford Neuroscience Health Center,Palo Alto,California,United States,94304 [10]Eisenhower Medical Center,Rancho Mirage,California,United States,92270 [11]Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine,Redwood City,California,United States,94063-3132 [12]California Pacific Medical Center - Sutter Health,San Francisco,California,United States,94109 [13]Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF),San Francisco,California,United States,94143-2202 [14]University of Colorado Denver, Anschutz Medical Campus,Aurora,Colorado,United States,80045 [15]Denver Arthritis Clinic,Denver,Colorado,United States,80230 [16]Yale Cancer Center-Yale University School Of Medicine,New Haven,Connecticut,United States,06520 [17]Georgetown University Hospital,Washington,District of Columbia,United States,20007 [18]UF Health Rheumatology,Gainesville,Florida,United States,32610-3008 [19]Mayo Clinic,Jacksonville,Florida,United States,32224 [20]University Of Miami,Miami,Florida,United States,33136 [21]University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare),Tampa,Florida,United States,33616 [22]Emory University Hospital, The Emory Clinic,Atlanta,Georgia,United States,30322 [23]Augusta University,Augusta,Georgia,United States,30312 [24]Northwestern Memorial Hospital,Chicago,Illinois,United States,60611 [25]Rush University Medical Center,Chicago,Illinois,United States,60612 [26]The University of Chicago Medical Center (UCMC) - Duchossois Center for Advanced Medicine (DCAM),Chicago,Illinois,United States,60637 [27]University Of Kansas Medical Center,Kansas City,Kansas,United States,66160 [28]University Of Louisville Healthcare Outpatient Center,Louisville,Kentucky,United States,40202 [29]Ochsner Medical Center (OMC),New Orleans,Louisiana,United States,70121 [30]Johns Hopkins Medicine - Johns Hopkins Myositis Center,Baltimore,Maryland,United States,21224 [31]Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Research Center (TRC),Boston,Massachusetts,United States,02115-6110 [32]Michigan State University - Neurology,East Lansing,Michigan,United States,48824 [33]University of Minnesota,Minneapolis,Minnesota,United States,55455 [34]Mayo Clinic,Rochester,Minnesota,United States,55905 [35]St. Paul Rheumatology, PA,Saint Paul,Minnesota,United States,55121 [36]Washington University School of Medicine,Saint Louis,Missouri,United States,63110 [37]Northwell Health,Great Neck,New York,United States,11021 [38]Hospital for Special Surgery,New York,New York,United States,10021 [39]University of North Carolina (UNC) School of Medicine,Chapel Hill,North Carolina,United States,27514-4220 [40]Carolina Arthritis Associates,Wilmington,North Carolina,United States,28401 [41]Cleveland Clinic,Cleveland,Ohio,United States,44195-0001 [42]Cleveland Clinic - Main Campus,Cleveland,Ohio,United States,44195 [43]The Ohio State University,Columbus,Ohio,United States,43201 [44]Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology,Oklahoma City,Oklahoma,United States,73120 [45]Oregon Health and Science University,Portland,Oregon,United States,97239 [46]Altoona Center for Clinical Research,Duncansville,Pennsylvania,United States,16635 [47]University of Pittsburg Medical Center,Pittsburgh,Pennsylvania,United States,15261 [48]Palmetto Primary and Specialty Care Physicians,Summerville,South Carolina,United States,29485 [49]Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic,Nashville,Tennessee,United States,37232-0028 [50]Austin Neuromuscular Center,Austin,Texas,United States,78759 [51]Texas Neurology, P.A.,Dallas,Texas,United States,75206 [52]University of Texas Southwestern Medical Center,Dallas,Texas,United States,75390-9179 [53]Texas Arthritis Center,El Paso,Texas,United States,79902 [54]McGovern Medical School -The University of Texas Health Science Center at Houston,Houston,Texas,United States,77030 [55]Nerve And Muscle Center Of Texas,Houston,Texas,United States,77030 [56]The University of Texas Health Science Center at San Antonio,San Antonio,Texas,United States,78229 [57]University of Vermont Medical Center - Main Campus,Burlington,Vermont,United States,05401 [58]University of Washington Medical Center,Seattle,Washington,United States,98195 [59]West Virginia University - Physician Office Center Department of Neurology,Morgantown,West Virginia,United States,26506 [60]West Virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic,Morgantown,West Virginia,United States,26506 [61]Consultora Integral de Salud,Córdoba,Argentina,5000 [62]Framingham Centro Medico,La Plata,Argentina,B1902COS [63]Dim Clinica Privada,Ramos Mejía,Argentina,B1704ETD [64]Sanatorio Parque S.A y Consultorios Externos Asociados,Rosario,Argentina,2000 [65]Centro de Investigaciones Medicas Tucuman,San Miguel De Tucumán,Argentina,T4000AXL [66]Centro Dermatologico Schejtman,San Miguel,Argentina,B1663GKT [67]The Wesley Medical Research,Auchenflower,Australia,4066 [68]Fiona Stanley Hospital,Murdoch,Australia,6150 [69]Medical University Innsbruck,Innsbruck,Austria,6020 [70]Kepler University Hospital,Linz,Austria,4021 [71]Klinikum Wels-Grieskirchen,Wels,Austria,4600 [72]Allgemeines Krankenhaus der Stadt Wien (AKH Wien),Wien,Austria,1090 [73]Hospital Hietzing in Vienna,Wien,Austria,1130 [74]Universite Libre de Bruxelles (ULB) - Hopital Erasme,Anderlecht,Belgium,1070 [75]Centre Hospitalier Universitaire de Charleroi,Charleroi,Belgium,6042 [76]AZ Sint Lucas Gent-Campus Sint Lucas,Gent,Belgium,9000 [77]Universitair Ziekenhuis Gent,Gent,Belgium,9000 [78]Universitair Ziekenhuis Leuven Gasthuisberg Campus,Leuven,Belgium,3000 [79]Universitair Ziekenhuis Leuven Gasthuisberg Campus,Leuven,Belgium,3000 [80]Centre Hospitalier Universitaire Sart Tilman,Liège,Belgium,4000 [81]Associacao de Assitencia a Crianca Deficiente(AACD),Sao Paulo,Brazil,04032-060 [82]Multiprofile Hospital for Active Treatment - Plovdiv AD,Plovdiv,Bulgaria,4000 [83]DCC Sveti Georgi,Plovdiv,Bulgaria,4002 [84]Medical Centre Artmed,Plovdiv,Bulgaria,4002 [85]Multiprofile hospital for active treatment Kaspela EOOD,Plovdiv,Bulgaria,4002 [86]Clinic of Rheumatology Multiprofile Hospital for Active Treatment Sveti Ivan Rilski,Sofia,Bulgaria,1612 [87]University of Alberta - Mazankowski Alberta Heart Institute (MAHI),Edmonton,Canada,T6G 2B7 [88]Applied Medical Informatics Research Inc. (A.M.I.R.),Montreal,Canada,H4A 3T2 [89]Genge Partners,Montréal,Canada,H4A 3T2 [90]Ottawa Hospital Research Institute-Civic Campus,Ottawa,Canada,K1Y 4E9 [91]China-Japan Friendship Hospital,Beijing,China,100029 [92]China-Japan Friendship Hospital,Beijing,China,100029 [93]Peking University First Hospital,Beijing,China,100034 [94]Peking University People's Hospital,Beijing,China,100044 [95]Peking University People's Hospital,Beijing,China,100044 [96]Xuanwu Hospital Capital Medical University,Beijing,China,100053 [97]Peking University Third Hospital,Beijing,China,100191 [98]Peking University Third Hospital,Beijing,China,100191 [99]Peking Union Medical College Hospital,Beijing,China,100730 [100]Cangzhou People's Hospital,Cangzhou,China,061001 [101]The First Hospital of Jilin University,Changchun,China,130021 [102]Xiangya Hospital Central South University,Changsha,China,410008 [103]The Second Xiangya Hospital of Central South University,Changsha,China,410011 [104]The Second Xiangya Hospital of Central South University,Changsha,China,410011 [105]The Third Xiangya Hospital of Central South University,Changsha,China,410013 [106]Xi'an Gaoxin Hospital,Changsha,China [107]GCP Center West China Hospital, Sichuan University,Chengdu,China,610041 [108]West China Hospital of Sichuan University,Chengdu,China,610041 [109]Sichuan Provincial Peoples Hospital,Chengdu,China,610072 [110]The First Affiliated Hospital Of Chongqing Medical University,Chongqing,China,400000 [111]The Second Affiliated Hospital, Chongqing Medical University,Chongqing,China,400010 [112]Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,Guangzhou,China,510000 [113]Guangdong Provincial People's Hospital,Guangzhou,China,510080 [114]Nanfang Hospital, Southern Medical University,Guangzhou,China,510515 [115]The affiliated Hospital of Guizhou Medical University,Guiyang,China,550001 [116]The First Affiliated Hospital - School of Medicine - ZheJiang University,Hangzhou,China,310003 [117]The First Affiliated Hospital, School of Medicine, ZheJiang University,Hangzhou,China,310003 [118]Zhejiang Provincial People's Hospital,Hangzhou,China,310014 [119]Anhui Provincial Hospital,Hefei,China,230001 [120]Anhui Provincial Hospital,Hefei,China,230001 [121]The Affiliated Hospital of Inner Mongolia Medical University,Hohhot,China,010050 [122]Qi-Lu Hospital of Shandong University School of Medicine,Jinan,China,250012 [123]Qi-Lu Hospital of Shandong University School of Medicine,Jinan,China,250012 [124]Shandong Provincial Hospital,Jinan,China,250021 [125]Kunming Medical University (KMU) - First Affiliated Hospital,Kunming,China,650032 [126]The Second Affiliated Hospital Of Nanchang University,Nanchang,China,330000

研究目的:
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

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