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在全身型重症肌无力患者中评价LOU064的疗效、安全性和耐受性的随机、双盲、安慰剂对照III期研究

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研究单位: [1]华中科技大学同济医学院附属同济医院 [2]上海市第一人民医院 [3]石家庄市人民医院(石家庄市第一医院、石家庄市肿瘤医院、河北省重症肌无力医院、石家庄市心血管病医院 [4]青岛大学附属医院 [5]北京医院 [6]安徽省立医院(中国科学技术大学附属第一医院 [7]无锡市人民医院(无锡市人体器官移植中心 [8]吉林大学第一医院 [9]郑州大学第一附属医院 [10]北京大学第一医院(北京大学第一临床医学院 [11]中山大学附属第一医院 [12]首都医科大学附属北京同仁医院 [13]Mallikatta Neuro Center [14]Chang Gung Memorial Hospital, Linkou [15]National Cheng Kung University Hospital [16]Seoul National University Hospital [17]Fortis Memorial Research Institute [18]Shin Kong Wu Ho Su Memorial Hospital [19]Kyushu University Hospital [20]National 台湾 University Hospital [21]Kyung Hee University Hospital at Gangdong [22]Christian Medical College and Hospitals-SH 207 Sasthri Nagar [23]Pusan National University Hospital [24]St Vincents Hospital Melbourne - PPDS [25]National Hospital Organization Sendai Medical Center [26]Higashi Matsuyama Municipal Hospital [27]Dayanand Medical College and Hospital [28]All 印度 Institute of Medical Sciences (AIIMS - New Delhi [29]Gold Coast University Hospital [30]General Hanamaki Hospital [31]Vivekananda Polyclinic and Institute of Medical Sciences, Lucknow [32]Southern Neurology - 10/11 Kensington St [33]Hiroshima University Hospital [34]National Hospital Organization Hokkaido Medical Center [35]Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital [36]Hyogo College of Medicine [37]The University of Osaka Hospital [38]Severance Hospital Yonsei University Health System [39]Tokyo Medical University Hospital [40]Sapporo Medical University Hospital [41]Chopda Medicare Research Centre Pvt. Ltd’s - Magnum Heart Institute [42]Chiba University Hospital [43]Fukushima Medical University Hospital [44]Nizams Institute of Medical Sciences [45]Universitatsklinikum Münster [46]Centre Hospitalier Universitaire (CHU de Bordeaux [47]Hopitaux Universitaires de Strasbourg [48]Sibiu Emergency County Clinical Hospital [49]Krakowska Akademia Neurologii Sp. z o.o. [50]Hospital Universitario Vall d'Hebron - PPDS [51]Hospital Universitario de Bellvitge [52]Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL [53]Hospital Universitari i Politecnic La Fe de Valencia [54]St George’s Hospital [55]Rejdak Konrad Indywidualna Praktyka Lekarska Prof. dr hab. n. med. Konrad Rejdak-ul. 1 Maja 14 [56]NMedis [57]Centrum Medyczne NeuroProtect-Zablocinska 10 [58]UZ Leuven [59]New Hospitals [60]Charite- Universitatsmedizin Berlin [61]Amsterdam UMC Location AMC- Meibergdreef 9 [62]Hospital Universitario Ramon y Cajal [63]CHU de Nice [64]UCK WUM, Centralny Szpital Kliniczny [65]Universitatsklinikum Hamburg Eppendorf [66]Med-Polonia Sp. z o.o. [67]Galen Clinic [68]Centre Hospitalier Universitaire de Toulouse [69]Uniwersytecki Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie [70]Azienda Ospedaliera Universitaria Federico II [71]Universitatsklinikum Carl Gustav Carus an der TU Dresden [72]Hospital Universitari Arnau de Vilanova [73]Hopital Fondation Adolphe de Rothschild - PPDS [74]University College Hospital [75]Galen Clinic - Warszawa [76]Hopital Bicetre [77]Pineo Medical Ecosystem [78]S.C. Neurocity S.R.L. [79]Hospital Clinico Universitario de Santiago [80]Hospital Regional Universitario de Malaga – Hospital General [81]Centrum Medyczne Neurologia Slaska [82]ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII [83]MTZ Clinical Research Powered by PRATIA - PPDS [84]Klinikum Oberberg GmbH [85]AP-HP - Hopital de la Pitie Salpetriere [86]Clinical Research Center Sp. z o.o. Medic-R sp.k. [87]Clinical Centre of Vojvodina [88]Azienda Ospedaliero-Universitaria San Luigi Gonzaga [89]University Clinical Center Nis [90]Opsta bolnica MSB – Medicinski Sistemi Beograd [91]West 格鲁吉亚 Medical Center [92]Neurocentrum Bydgoszcz sp. z o.o. [93]MICS Centrum Medyczne Bydgoszcz [94]INECO Neurociencias Orono [95]STAT Research S.A. [96]Fundacao Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde [97]L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME [98]Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo [99]Sanatorio Mater Dei [100]Instituto do Cerebro do Rio Grande do Sul - InsCer [101]Hospital Santa Izabel [102]Centro de Investigaciones Médicas Tucumán - PPDS [103]Centro de Investigación en Enfermedades Reumáticas - CIER [104]Hospital General de Agudos Dr. José María Ramos Mejia [105]Clinica Privada Velez Sarsfield [106]University of North Carolina at Chapel Hill [107]Michigan State University - Department of Neurology [108]Massachusetts General Hospital [109]Colorado Springs Neurological Associates [110]Henry Ford Hospital [111]University of Alberta Hospital [112]Mid-Atlantic Epilepsy and Sleep Center [113]University of Washington Medical Center [114]California Pacific Medical Center – Van Ness Campus [115]University of Pittsburgh Medical Center [116]Colorado Springs Neurological Associates [117]Houston Methodist Hospital [118]AdventHealth Innovation Tower [119]London Health Sciences Centre [120]Ottawa Hospital Research Institute [121]Neurological Services of Orlando [122]University of Colorado - Anschutz Medical Campus - PPDS [123]CHU de Quebec-Universite Laval [124]HonorHealth Neurology - Bob Bové Neuroscience Institute - PPDS [125]University of Texas - San Antonio - Health Science Center - PPDS [126]University of Texas Houston Medical School [127]University of Southern California [128]Toronto General Hospital [129]SFM Clinical Research, LLC [130]University Of Cincinnati Gardner Neuroscience institute [131]Dent Neurologic Institute - Amherst [132]Fullerton Neurology and Headache Center [133]Homestead Associates in Research Inc-30328 Old Dixie Hwy [134]University of California Irvine [135]Center for Neurological Disorders - Greenfield [136]Neuromuscular Research Center [137]Suncoast Neuroscience Associates Inc [138]Neurology Associates PA - 331 N Maitland Ave [139]University of Chicago [140]复旦大学附属华山医院

研究目的:
主要目的:证明在接受稳定SOC治疗的gMG患者中,LOU064与安慰剂相比在治疗6个月(第180天时降低重症肌无力日常生活活动(MG-ADL量表总分方面的疗效 关键次要目的: 在gMG患者中评估remibrutinib在以下方面是否优于安慰剂 治疗6个月时降低定量MG(QMG总分 从基线至第6个月QMG总分降低 ≥ 5分且未使用急救药物和/或强混杂性禁用药物的研究参与者比例 从基线至第6个月MG-ADL总分降低 ≥ 3分且未使用急救药物和/或强混杂性禁用药物的研究参与者比例 治疗第6个月时降低重症肌无力复合量表(MGC总分 第6个月时达到最小症状表现(MSE(定义为第6个月时MG-ADL评分为0或1且未使用急救治疗和/或强混杂性禁用药物 治疗第6个月时降低MG-QOL15r调查评分

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