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A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

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研究单位: [1]Hoffmann-La Roche [2]Chugai Pharmaceutical [3]Neurology,Samsun,Turkey,55139 [4]HonorHealth Neurology,Scottsdale,Arizona,United States,85251 [5]Keck School of Medicine of USC,Los Angeles,California,United States,90033 [6]University of California Irvine - Manchester Pavilion,Orange,California,United States,92868 [7]SC3 Research Group, Inc,Pasadena,California,United States,91105 [8]Medical Faculty Associates Inc.,Washington,District of Columbia,United States,20037 [9]University of Florida Jacksonville Physicians Inc. (UFJPI),Jacksonville,Florida,United States,32209 [10]University of Chicago Hospital,Chicago,Illinois,United States,60637 [11]Prairie Education and Research,O'Fallon,Illinois,United States,62269 [12]University of Iowa Hospitals & Clinics [13]Department of Neurology,Iowa City,Iowa,United States,52242 [14]Massachusetts General Hospital,Boston,Massachusetts,United States,02114-2621 [15]Washington University School of Medicine [16]Department of Neurology,Saint Louis,Missouri,United States,63110 [17]University at Buffalo / SUNY [18]UBMD Neurology,Buffalo,New York,United States,14203 [19]South Shore Neurologic Associates P.C.,Patchogue,New York,United States,11772 [20]NeuroScience Research Center,Canton,Ohio,United States,44718 [21]The Ohio State University Wexner Medical Center [22]Department of Neurology,Columbus,Ohio,United States,43221 [23]Hospital Italiano [24]Neurology,Caba,Argentina,C1199ABA [25]Hospital Ramos Mejía,Caba,Argentina,C1221ADC [26]Hospital Britanico,Ciudad Autonoma Bs As,Argentina,C1280AEB [27]Fundación Scherbovsky [28]General Department,Mendoza,Argentina,M5500AYB [29]INECO Neurociencias Orono,Rosario,Argentina,S2000DTC [30]Centro de Investigaciones Médicas Tucuman [31]REUMATHOLOGY,San Miguel,Argentina,T4000AXL [32]Concord Repatriation General Hospital,Concord,New South Wales,Australia,2139 [33]Princess Alexandra Hospital,Woolloongabba,Queensland,Australia,4102 [34]Box Hill Hospital [35]Department of Neurology,Box Hill,Victoria,Australia,3128 [36]Instituto de Neurologia de Curitiba,Curitiba,PR,Brazil,81210-310 [37]Hospital Sao Lucas - PUCRS,Porto Alegre,RS,Brazil,90610-000 [38]Hospital das Clinicas - UNICAMP,Campinas,SP,Brazil,13083-887 [39]Faculdade de Medicina do ABC - FMABC,Santo Andre,SP,Brazil,09060-650 [40]Hospital Sao Paulo,Sao Paulo,SP,Brazil,04037-002 [41]MUCH - Montreal Neurological Institute & Hospital,Montreal,Quebec,Canada,H3A 2B4 [42]Beijing Tiantan Hospital,Capital Medical University,Beijing City,China,100050 [43]Beijing Tongren Hospital,Beijing,China,100730 [44]The First Hospital of Jilin University,Changchun City,China,130021 [45]Hunan Children's Hospital,Changsha City,China,410007 [46]Xiangya Hospital Central South University,Changsha City,China,410008 [47]West China Hospital - Sichuan University,Chengdu City,China,610047 [48]The Affiliated Hospital of Guizhou Medical University,Guiyang City,China,550000 [49]Sir Run Run Shaw Hospital,Hangzhou City,China,310018 [50]The First Affiliated Hospital Of Shandong First Medical University,Jinan City,China,250014 [51]Huashan Hospital, Fudan University,Shanghai City,China,200040 [52]Children's Hospital of Fudan University,Shanghai,China,201102 [53]Tianjin Medical University General Hospital,Tianjin,China,300052 [54]The First Affiliated Hospital of Wenzhou Medical University,Wenzhou City,China,325035 [55]Tongji Hospital Tongji Medical College Huazhong University of Science and Technology,Wuhan City,China,430030 [56]Tangdu Hospital,Xi'an City,China,710038 [57]Aarhus Universitetshospital [58]Neurologisk Klinik,Aarhus N,Denmark,8200 [59]Rigshospitalet [60]Klinik for Nerve- og Muskelsygdomme,København Ø,Denmark,2100 [61]APHP Raymond Poincare,Garches,France,92380 [62]Hopital Timone Adultes [63]Neurologie Mal Neuro Musculaires,Marseille,France,13385 [64]CHU de Nantes - Hotel Dieu,Nantes,France,44093 [65]CHU Nice - Hôpital Pasteur 2 [66]SYST NERVEUX PERIPHERIQUE MUSCLE,Nice,France,06000 [67]CHU Bordeaux,Pessac,France,33604 [68]St. Josef-Hospital, Klinik für Neurologie,Bochum,Germany,44791 [69]Universitätsklinikum Essen (AöR) [70]Klinik für Neurologie,Essen,Germany,45147 [71]Univeristätsklinikum Leipzig [72]Klinik und Poliklinik für Neurologie,Leipzig,Germany,04103 [73]Universitätsklinikum Münster [74]Klinik und Poliklinik für Neurologie,Münster,Germany,48149 [75]Azienda Ospedaliera A. Cardarelli [76]Dipartimento medico polispecialistico,Napoli,Campania,Italy,80131 [77]A.O. Sant'Andrea [78]UOC Neurologia, Dip. Di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS),Roma,Lazio,Italy,00189 [79]Fond. Istituto Neurologico C.Besta [80]UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari,Milano,Lombardia,Italy,20133 [81]Fondazione Istituto Neurologico Mondino IRCCS [82]SC Neuroncologia e neuroinfiammazione,Pavia,Lombardia,Italy,27100 [83]A.R.N.A.S. Civico Di Cristina Benfratelli [84]U.O.C. Neurologia con Stroke Unit,Palermo,Sicilia,Italy,90127 [85]Ospedale Cà Foncello [86]S.C Neurologia,Treviso,Veneto,Italy,31100 [87]Juntendo University Hospital [88]Neurology,Bunkyo-ku,Japan,113-8431 [89]Chiba University Hospital [90]Neurology,Chiba-shi, Chiba,Japan,260-8677 [91]General Hanamaki Hospital [92]Neurology,Hanamaki, Iwate,Japan,025-0082 [93]Hiroshima University Hospital,Hiroshima,Japan,734-8551 [94]Sapporo Medical University Hospital [95]Neurology,Hokkaido,Japan,060-8543 [96]NHO Hokkaido Medical Center,Hokkaido,Japan,063-0005 [97]Kagawa University Hospital [98]Neurology,Kagawa,Japan,761-0793 [99]St. Marianna University Hospital,Kanagawa,Japan,216-8511 [100]Saitama Medical Center [101]Neurology,Kawagoe-shi, Saitama,Japan,350-8550 [102]Nagasaki Kawatana Medical Center [103]Neurology,Nagasaki,Japan,859-3615 [104]International University of Health and Welfare Narita Hospital [105]Neurology,Narita, Chiba,Japan,286-0124 [106]Kindai University Hospital [107]Neurology,Osaka,Japan,589-8511 [108]Osaka Toneyama Medical Center [109]Neurology,Osaka,Japan [110]Dokkyo Medical University Saitama Medical Center [111]Neurology,Saitama,Japan,343-8555 [112]Tokyo Women's Medical University Hospital [113]Neurology,Shinjuku-ku,Japan,162-8666 [114]Seirei Hamamatsu General Hospital,Shizuoka,Japan,430-8558 [115]Osaka University Hospital [116]Neurology,Suita,Japan,565-0871 [117]Tokyo Medical And Dental University, Medical Hospital [118]Neurology,Tokyo,Japan,113-8519 [119]Tokyo Medical University Hospital,Tokyo,Japan,160-0023 [120]Kyungpook National University Chilgok Hospital,Daegu,Korea, Republic of,41404 [121]Pusan National University Yangsan Hospital,Gyeongsangnam-do,Korea, Republic of,50612 [122]Severance Hospital, Yonsei University Health System,Seoul,Korea, Republic of,003-722 [123]Korea University Anam Hospital,Seoul,Korea, Republic of,02841 [124]Samsung Medical Center,Seoul,Korea, Republic of,135-710 [125]Amsterdam UMC Location AMC,Amsterdam,Netherlands,1105 AZ [126]LUMC,Leiden,Netherlands,2333 ZA [127]Klinika Neurologii Doros?ych, Uniwersyteckie Centrum Kliniczne,Gda?sk,Poland,80-952 [128]Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K,Krakow,Poland,31-505 [129]Zespol Poradni Specjalistycznych - Poradnia Neurologiczna [130]Szpital Uniwersytecki w Krakowie,Kraków,Poland,31-503 [131]FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency,Krasnoyarsk,Krasnojarsk,Russian Federation,660037 [132]Krasnoyarsk State Medical Academy,Krasnoyarsk,Krasnojarsk,Russian Federation,660049 [133]National Center of Social Significant Disease,Sankt-peterburg,Leningrad,Russian Federation,197110 [134]Novosibirsk State Regional Clinical Hospital,Novosibirsk,Russian Federation,630087 [135]Leningrad Regional Clinical Hospital,St Petersburg,Russian Federation,194291 [136]Hospital Universitari de Bellvitge [137]Servicio de Neurologia,L'Hospitalet de Llobregat,Barcelona,Spain,08907 [138]Hospital de Donostia Unidad Demencias [139]Consultas de Neurología,San Sebastian,Guipuzcoa,Spain,20080 [140]Hospital Universitario Infanta Sofia [141]Servicio de Neurologia,San Sebastian de los Reyes,Madrid,Spain,28702 [142]Clinica Universitaria de Navarra [143]Servicio de Neurología,Pamplona,Navarra,Spain,31008 [144]Hospital de la Santa Creu I Sant Pau [145]Servicio de Neurologia,Barcelona,Spain,08041 [146]Hospital General Universitario Gregorio Marañon [147]Servicio de Neurologia,Madrid,Spain,28007 [148]Clinica Universitaria Navarra [149]Servicio Neurologia,Madrid,Spain,28027 [150]Hospital Universitario la Fe [151]Servicio de Neurologia,Valencia,Spain,46026 [152]Taipei Veterans General Hospital-Neurology,Taipei,Taiwan,11217 [153]Chang Gung Medical Foundation Linkou Branch,Taoyuan City,Taiwan,333 [154]Hacettepe University Medical Faculty [155]Neurology,Ankara,Turkey,06100 [156]Ege University Medical Faculty,Izmir,Turkey,35100 [157]Kocaeli University Hospital [158]Department of Neurology,Kocaeli,Turkey,41380 [159]Ondokuz Mayis Univ. Med. Fac.

研究目的:
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).

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