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评价萨特利珠单抗对比安慰剂在全身型重症肌无力治疗的有效性、安全性、药代动力学和药效学的III 期、随机、双盲、 安慰剂对照、多中心研究

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研究单位: [1]复旦大学附属华山医院 [2]Neurology [3]REUMATHOLOGY [4]Department of Neurology [5]Neurologisk Klinik [6]Afdeling for Hjerne- og Nervesygdomme [7]Neurologie Mal Neuro Musculaires [8]SYST NERVEUX PERIPHERIQUE MUSCLE [9]Klinik und Poliklinik für Neurologie [10]Klinik für Neurologie [11]SC Neuroncologia e neuroinfiammazione [12]UOC Neurologia,Dip. di Neuroscienze,Salute Mentale e Organi di Senso (NESMOS) [13]UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari [14]Dipartimento medico polispecialistico [15]S.C Neurologia [16]U.O.C. Neurologia con Stroke Unit [17]Szpital Uniwersytecki w Krakowie [18]Servicio de Neurologia [19]Servicio de Neurología [20]DEPARTMENT OF NEUROLOGY [21]四川大学华西医院 [22]首都医科大学宣武医院 [23]中国人民解放军第四军医大学唐都医院 [24]吉林大学第一医院 [25]温州医科大学附属第一医院 [26]山西医科大学第一医院 [27]首都医科大学附属北京同仁医院 [28]华中科技大学同济医学院附属同济医院 [29]中南大学湘雅医院 [30]北京医院 [31]天津医科大学总医院 [32]山东省千佛山医院 [33]浙江大学医学院附属邵逸夫医院 [34]首都医科大学附属北京天坛医院 [35]贵州医科大学附属医院 [36]湖南省儿童医院 [37]复旦大学附属儿科医院 [38]Hospital Britanico [39]Hospital Ramos Mejía [40]Hospital Italiano [41]Centro de Investigaciones Médicas Tucuman [42]Concord Repatriation General Hospital [43]Box Hill Hospital [44]Princess Alexandra Hospital [45]Faculdade de Medicina do ABC - FMABC [46]MUCH - Montreal Neurological Institute & Hospital [47]Aarhus Universitetshospital [48]Rigshospitalet [49]Hopital Timone Adultes [50]APHP Raymond Poincare [51]CHU Nice - H?pital Pasteur 2 [52]CHU de Nantes - Hotel Dieu [53]CHU Bordeaux [54]Universit?tsklinikum Münster [55]St. Josef-Hospital,Klinik für Neurologie [56]Univerist?tsklinikum Leipzig [57]Universit?tsklinikum Essen (A?R) [58]Fondazione Istituto Neurologico Mondino IRCCS [59]A.O. Sant'Andrea [60]Fond. Istituto Neurologico C.Besta [61]Azienda Ospedaliera A. Cardarelli [62]Ospedale Cà Foncello [63]A.R.N.A.S. Civico Di Cristina Benfratelli [64]General Hanamaki Hospital [65]Kagawa University Hospital [66]Juntendo University Hospital [67]Osaka Toneyama Medical Center [68]Chiba University Hospital [69]Kindai University Hospital [70]Nagasaki Kawatana Medical Center [71]Saitama Medical Center [72]NHO Hokkaido Medical Center [73]Osaka University Hospital [74]Sapporo Medical University Hospital [75]Tokyo Women's Medical University Hospital [76]Tokyo Medical And Dental University,Medical Hospital [77]International University of Health and Welfare Narita Hospital [78]St. Marianna University Hospital [79]Seirei Hamamatsu General Hospital [80]Hiroshima University Hospital [81]Dokkyo Medical University Saitama Medical Center [82]Samsung Medical Center [83]Severance Hospital,Yonsei University Health System [84]Korea University Anam Hospital [85]Kyungpook National University Chilgok Hospital [86]Pusan National University Yangsan Hospital [87]Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K [88]Zespol Poradni Specjalistycznych - Poradnia Neurologiczna [89]Klinika Neurologii Doros?ych,Uniwersyteckie Centrum Kliniczne [90]National Center of Social Significant Disease [91]Novosibirsk State Regional Clinical Hospital [92]Leningrad Regional Clinical Hospital [93]Krasnoyarsk State Medical Academy [94]FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency [95]Hospital de la Santa Creu i Sant Pau [96]Hospital Universitari de Bellvitge [97]Hospital Universitario la Fe [98]Clinica Universitaria de Navarra [99]Taipei Veterans General Hospital-Neurology [100]Chang Gung Medical Foundation Linkou Branch [101]Ondokuz Mayis Univ. Med. Fac. [102]Kocaeli University Hospital [103]Ege University Medical Faculty [104]Hacettepe University Medical Faculty [105]Keck School of Medicine of USC [106]NeuroScience Research Center [107]University of Iowa Hospitals & Clinics [108]HonorHealth Neurology [109]University of Florida Jacksonville Physicians Inc. (UFJPI) [110]UNIVERSITY OF CHICAGO HOSPITAL [111]University of California Irvine - Manchester Pavilion [112]WASHINGTON UNIVERSITY SCHOOL OF MEDICINE [113]Medical Faculty Associates Inc

研究目的:
本研究将在接受稳定背景治疗的 gMG 患者中评价萨特利珠单抗对比安慰剂的有效性、安全性、药代动力学和药效学。此外,本研究将在开放性扩展(OLE)期评估萨特利珠单抗的长期安全性和有效性

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