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BTK抑制剂SAR442168的RMS研究(GEMINI 1)

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研究单位: [1]中国医学科学院北京协和医院 [2]中国医学科学院北京协和医院 [3]复旦大学附属华山医院 [4]吉林大学第一医院 [5]四川大学华西医院 [6]北京大学第一医院 [7]山西医科大学第一医院 [8]北京医院 [9]首都医科大学附属北京天坛医院 [10]华中科技大学同济医学院附属同济医院 [11]首都医科大学宣武医院 [12]河北医科大学第二医院 [13]中国人民解放军空军军医大学第二附属医院 [14]中国医科大学附属盛京医院 [15]重庆医科大学附属第一医院 [16]天津医科大学总医院 [17]中国人民解放军总医院 [18]包头市中心医院 [19]北京大学第三医院 [20]首都医科大学附属北京同仁医院 [21]内蒙古医科大学附属医院 [22]南方医科大学南方医院 [23]宁夏医科大学总医院 [24]福建医科大学附属第一医院 [25]南京脑科医院 [26]南京鼓楼医院 [27]中山大学附属第三医院 [28]Kepler Universittsklinikum [29]MHAT [30]MHAT [31]SHATNPsy [32]UMHT Sveti Georgi EAD,Plovdiv [33]UMHAT Alexandrovska [34]Acibadem City Clinic MHAT Tokuda EAD [35]Diagnostic Consultative Center Convex EOOD [36]Vitebsk Regional Clinical Hospital [37]Vitebsk Regional Diagnostic Center [38]The Ottawa Hospital [39]Clinique Neuro-Outaouais [40]Clinique Neuro-Outaouais [41]St. Michael's Hospital [42]UBC Hospital [43]Medical Arts Health Research Group [44]Krajska zdravotni,a.s. - Nemocnice Teplice,o.z. [45]Fakultni nemocnice Hradec Kralove [46]Krajska nemocnice Tomase Bati a.s. [47]Nemocnice Pardubickeho kraje,a.s. [48]Universit tsklinikum Dresden [49]Universi tsklinikum Münster [50]Universit tsklinikum Ulm [51]MultipEL Studies [52]Universittsklinikum Düsseldorf [53]Sydvestjysk Sygehus Esbjerg [54]Aalborg University hospital [55]Regionshospitalet Holstebro [56]Sygehus Lillebaelt Kolding [57]Hospital Universitario Quirónsalud Madrid. [58]Hospital Universitario la Princesa. [59]Hospital Universitario Virgen Macarena. [60]Hospital Universitario Reina Sofía. [61]Hospital Carlos Haya. [62]Hospital Virgen De La Arrixaca. [63]Hospital Universitari i Politècnic La Fe [64]Hospital De Donostia. [65]Hospital Universitari Vall d'Hebron. [66]Astra Clinic [67]SA Tartu ülikooli Kliinikum [68]SA Prnu Haigla [69]Tampereen yliopistollinen keskussairaala [70]Turun Yliopistollinen Keskussairaala,Neurologia [71]Terveystalo Ruoholahti [72]Prince Of Wales Hospital [73]Queen Mary Hospital [74]Queen Mary Hospital [75]Ospedale San Raffaele [76]IRCCS Neuromed [77]Università Degli Studi Di Napoli Federico II [78]Ospedale Maggiore Policlinico [79]Azienda Ospedaliera San Camillo Forlanini [80]AOU DELLUNIV. DEGLI STUDI DELLA CAMPANIA “LUIGI VANVITELLI [81]Azienda Sanitaria Ospedaliera San Luigi Gonzaga [82]AOU DELLUNIV. DEGLI STUDI DELLA CAMPANIA “LUIGI VANVITELLI [83]Azienda Sanitaria Ospedaliera San Luigi Gonzaga [84]Istituto Neurologico Casimiro Mondino [85]Policlinico Gemelli Universita' Cattolica Del Sacro Cuore [86]Istituto Neurologico Carlo Besta [87]Azienda Ospedaliera Papa Giovanni XXIII [88]Azienda Universitario Ospedaliera Policlinico Di Careggi [89]Azienda Ospedaliera santAndrea [90]Azienda Ospedaliera San Martino [91]Azienda Ospedaliero-Universitaria Policlinico [92]National Center of Neurology and Psychlatry [93]National Center of Neurology and Psychlatry [94]Kansai Medical University Medical Center [95]Niigata University Medical and Dental Hospital [96]Southern Tohoku Medical Clinic [97]Yamaguchi University Hospital [98]Ebara Hospital [99]University of Tsukuba Hospital [100]University of Tsukuba Hospital [101]Tokyo Womens Medical University Hospital [102]Juntendo University Hospital [103]Chiba University Hospital [104]Keio University School of Medicine [105]Saitama Medical Center [106]Iwate Medical University Uchimaru Medical Center [107]Vilnius University Hospital Santaros klinikos [108]Klaipeda University Hospital [109]Hospital of Lithuanian University of Health Sciences Kauno klinikos [110]Republican Siauliai Hospital [111]Clinstile S.A. de C.V. [112]Grupo Médico de Investigacion Clinica Multidisciplinaria S.C. [113]Arké SMO,S.A. de C.V. [114]Uniwersytecki Szpital Kliniczny im. WAM - Szpital Weteranow [115]MA-LEK Centrum Terapii SM [116]Neurocentrum Bydgoszcz [117]NEURO-MEDIC Janusz Zbrojkiewicz [118]Szpital Wolski [119]Centrum Medyczne Neuroprotect [120]Neurologiczny NZOZ Centrum Leczenia SM [121]Szpital Specjalistyczny im. Swietej Rodziny [122]Instytut Psychiatrii I Neurologii [123]MED-POLONIA [124]Spitalul Clinic Judetean De Urgenta Targu Mure,Sectia Neurologie I [125]Spitalul Clinic Judetean de Urgenta [126]Spitalul Clinic de Cai Ferate Constanta,Sectia Neurologie [127]Clubul Sanatatii,Neurologie [128]Aria Clinic SRL [129]Institutul Clinic Fundeni,Neurologie 1 [130]Spitalul Clinic Jude?ean de Urgenta Oradea,Sta?ionar 1,Sectia Neurologie [131]SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL [132]Military Medical Academy n.a.Kirov [133]Research Center Of Neurology [134]Privolzhskiy Research Medical University [135]Republican clinical hospital named after Kuvatov [136]Samara Region Clinical Hospital n.a.V. Seredavin [137]MSC Neftyanik [138]City Hospital #2 of Pyatigorsk [139]Private Healthcare Institution Central Clinical Hosptal [140]Smolensk Regional Clinical Hospital [141]Medical center [142]Rostov State Medical University [143]Professorial clinic of KrasGMU n.a. Voyno-Yasenetsky of Ministry of Health of Russia [144]Sahlgrenska Universitetssjukhuset [145]Akademiskt Specialistcentrum [146]Kocaeli Universitesi [147]Istanbul Universitesi Cerrahpasa Tip Fakultesi [148]SB Haseki Egitim Ve Arastirma Hastanesi [149]Eskisehir Osmangazi University Medical Faculty [150]Mersin Universitesi Tip Fakultesi [151]Sancaktepe ?ehit Profes?r ?lhan Varank E?itim Ve Ara?t?rma Hastanesi [152]Ege Universitesi Tip Fakultesi [153]Ege Universitesi Tip Fakultesi [154]Haydarpasa Numune Egitim Ve Arastirma Hastanesi [155]?zmir Katip Celebi Ataturk Egitim Arast?rma Hospital [156]Mustafa Kemal University Medicine Faculty [157]Cheng Hsin General Hospital [158]China Medical University Hospital [159]Chang Gung Memorial Hospital - Kaohsiung [160]Chang Gung Memorial Hospital - Linkou [161]National Taiwan University Hospital [162]Lviv Regional Clinical Hospital [163]Kherson City Clinical Hospital named after E.E. Karabelesha [164]Odesa Regional Clinical Hospital [165]Volyn Regional Clinical Hospital [166]Limited liability company Neuro Global [167]O.F. Herbachevskyi Regional Clinical Hospital under Zhytomyr Regional Council [168]Kharkiv Railway Clinical Hospital #1 of Branch [169]State Institution Clinic [170]Institute of Neurology,Psychiatry and Narcology [171]Axiom Clinical Research of Florida [172]Meridian Clinical Research [173]Raleigh Neurology Associates [174]University of South Florida [175]Columbus Neuroscience [176]Consultants In Neurology [177]University of Colorado [178]University of Alabama MS Center [179]Oklahoma Medical Research Foundation [180]Missouri Baptist Medical Center [181]Providence Multiple Sclerosis Center [182]The Memorial Hospital [183]Beth Israel Deaconess Medical Center [184]Tufts Medical Center [185]Pennsylvania State University [186]University of Texas Southwestern Medical Center [187]Wake Forest University Baptist Medical Center [188]Georgetown University Medical Center [189]Multiple Sclerosis Center,Swedish Neuroscience Institute [190]Optimed Research,LTD [191]中山大学附属第一医院 [192]中南大学湘雅医院

研究目的:
主要目的:评估SAR442168每日一次相对于特立氟胺(奥巴捷®)每日一次14 mg给药的疗效,采用复发性MS受试者中的年裁定复发率(ARR)评估;次要目的:评估SAR442168相对于特立氟胺(奥巴捷®)在残疾进展、磁共振成像(MRI)病变、认知表现和生活质量方面的疗效;评价SAR442168每日给药的安全性和耐受性;评价SAR442168和相关代谢产物的群体药代动力学及其与疗效和安全性的关系;评价SAR442168的药效动力学(PD)

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