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一项在患有活动性亚急性皮肤型红斑狼疮和/或慢性皮肤型红斑狼疮(有或无全身表现)且抗疟药治疗反应不佳和/或不耐受的成人受试者中评价 BIIB059 (Litifilimab) 持续安全性和疗效的多中心、开放性、单组、III 期长期扩展临床研究 (AMETHYST LTE)

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研究单位: [1]中国医学科学院皮肤病医院(中国医学科学院皮肤病研究所) [2]Rheumatology Research, PLLC [3]Osteoporosis Clinic [4]Dental Hospital [5]Research SA de CV [6]Research Center [7]吉林大学第一医院 [8]中南大学湘雅二医院 [9]南方医科大学南方医院 [10]首都医科大学附属北京朝阳医院 [11]复旦大学附属中山医院 [12]中国医学科学院北京协和医院 [13]山东大学齐鲁医院 [14]上海交通大学医学院附属瑞金医院 [15]杭州市第一人民医院 [16]昆明医科大学第二附属医院 [17]中山大学孙逸仙纪念医院 [18]河南省人民医院 [19]上海市皮肤病医院 [20]浙江大学医学院附属第一医院 [21]深圳市第二人民医院 [22]福建医科大学附属第一医院 [23]重庆医科大学附属第一医院 [24]内蒙古科技大学包头医学院第一附属医院 [25]南阳市第一人民医院 [26]首都医科大学附属北京同仁医院 [27]东莞市人民医院 [28]江苏大学附属医院 [29]温州医科大学附属第一医院 [30]CINME - Centro De Investigaciones Metabolicas [31]Instituto CAICI [32]Hospital Italiano de La Plata [33]APRILLUS Asistencia e Investigacion [34]Centro Privado de Medicina Familiar - Mind Out Research [35]Centro de Investigaciones Medicas Mar del Plata [36]Centro de Investigaciones Medicas Tucuman [37]Fundacion Respirar [38]Investigaciones Clinicas Tucuman [39]San Miguel de Tucuman [40]Instituto de Reumatologia [41]Instituto de Investigaciones Clinicas Quilmes [42]Clinica Mayo de Urgencias Medicas Cruz Blanca SRL [43]Clinica Adventista Belgrano [44]CHU de Liege [45]UZ Leuven [46]Cliniques Universitaires Saint-Luc [47]Universitair Ziekenhuis Gent [48]HUWC - UFC - Hospital Universitário Walter Cantidio - Universidade Federal do Ceara [49]LMK Servios Medicos S/S Ltda [50]Hospital Bruno Born [51]CMiP - Centro Mineiro de Pesquisa [52]Clinica SER da Bahia [53]Santa Casa de Misericórdia de Belo Horizonte [54]Nucleo de Pesquisa Clinica do Rio Grande do Sul [55]CEPIC - Centro Paulista de Investigacao Clinica e Servieos Medicos [56]CEDOES - Diagnostico e Pesquisa [57]IPC MT Instituto de Pesquisas Clinicas do Mato Grosso [58]L2IP – Instituto de Pesquisas Clínicas Ltda. [59]CEMEC – Centro Multidisciplinar de Estudos Clínicos [60]Hospital de Clinicas de Porto Alegre [61]Instituto Brasil de Pesquisa Clinica-IBPCLIN S/A [62]IDERJ - Instituto de Dermatologia e Estetica do Brasil Ltda [63]DCC Focus 5 - MEOH OOD [64]UMHAT Dr. Georgi Stranski, EAD [65]DCC 1 - Ruse, EOOD [66]DCC Alexandrovska, EOOD [67]Medical Center Medconsult Pleven OOD [68]Military Medical Academy - MHAT - Sofia [69]DCC Focus 5 - MEOH OOD [70]Dermatology Ottawa Research Centre [71]DIEX Recherche Sherbrooke Inc. [72]Medicor Research Inc [73]Laster Rejuvenation Clinics Edmonton D.T. Inc. [74]Laser Rejuvenation Clinics, Inc. [75]CIEC - Centro Internacional de Estudios Clinicos [76]Clinical Research Chile SpA. [77]Oncocentro APYS [78]Dermacross [79]CeCim Biocinetic [80]Centro Medico SkinMed [81]BioMedica Research Group [82]Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM [83]SERVIMED S.A.S. [84]Healthy Medical Center [85]Centro de Investigacion Medico Asistencial S.A.S [86]Hopital Saint-Louis [87]Hopital Tenon [88]Hopital Edouard Herriot - CHU Lyon [89]CHU Nice - Hopital de l Archet [90]Hopital Larrey [91]Hopital Saint Eloi [92]Hopital Prive dAntony [93]CHU Besancon - Hopital Jean Minjoz [94]Hopital de la Timone [95]Whipps Cross University Hospital [96]Manchester Royal Infirmary [97]Chapel Allerton Hospital [98]Queen Elizabeth Hospital [99]Omega Research Debary, LLC [100]David Fivenson, MD, Dermatology, PLLC [101]Clinical Science Institute [102]Inland Rheumatology Clinical Trials, Inc. [103]Centre for Rheumatology, Immunology and Arthritis [104]Revival Research Institute, LLC [105]Dermatology Research Associates [106]NYU Langone Brooklyn [107]University of Pennsylvania [108]Ohio State University [109]Arizona Arthritis &amp [110]Northwell Health, Inc. PRIME [111]Dawes Fretzin Dermatology Group, LLC [112]UT Southwestern Medical Center [113]Arthritis &amp [114]University of North Carolina at Chapel Hill [115]Penn State University Milton S. Hershey Medical Center [116]UAB Center for Women's Reproductive Health [117]AA MRC LLC Ahmed Arif Medical Research Center [118]Universal Dermatology, PLLC [119]Duke Dermatology South Durham [120]Albuquerque Center For Rheumatology [121]Saint Louis University [122]University Hospitals Cleveland Medical Center [123]UTMB Department of Dermatology [124]University of Cincinnati Department of Dermatology [125]University of Massachusetts, Worcester [126]University of Nebraska Medical Center [127]University of Utah Health Sciences Center [128]Columbia University Medical center [129]Vanderbilt University Medical Center [130]Denver Arthritis Clinic [131]Metroplex Clinical Research Center, LLC [132]The Regents of the University of California [133]West End Dermatology Associates [134]Precision Comprehensive Clinical Research Solutions [135]OrthoIllinois [136]Medical Research Center of Miami [137]Brigham And Women's Hospital [138]Charisma Medical and Research Center [139]University of New Mexico School of Medicine [140]Essential Dermatology [141]Beacon Clinical Research, LLC [142]Oakland Hills Dermatology [143]North Texas Center for Clinical Research [144]University of Texas Health Science Center at Houston [145]Tufts Medical Center [146]University of Miami Miller School of Medicine [147]University of Florida [148]Rush University Medical Center [149]Kaohsiung Chang Gung Memorial Hospital [150]Changhua Christian Medical Foundation Changhua Christian Hospital [151]Taipei Veterans General Hospital [152]Taichung Veterans General Hospital [153]Charite - Campus Charite Mitte [154]Universitaetsklinikum Erlangen [155]Universitaetsklinikum Muenster [156]Universitaetsklinikum Carl Gustav Carus TU Dresden [157]Universitaetsklinikum Bonn AoeR [158]Universitaetsklinikum Schleswig-Holstein - Campus Kiel [159]Klinikum Oldenburg AoeR [160]Universitaetsklinikum Heidelberg [161]Fachklinik Bad Bentheim Dermatologie [162]Elbekliniken Buxtehude GmbH [163]Universitaetsklinikum Halle (Saale) [164]Universitaetsklinikum Aachen AoeR [165]Pecsi Tudomanyegyetem [166]Fondazione Policlinico Universitario Agostino Gemelli IRCCS [167]Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS [168]Azienda Ospedaliera Universitaria Policlinico Federico II [169]Ospedale San Raffaele [170]Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico [171]Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) [172]Universita degli studi di Firenze [173]IRCCS Ospedale Policlinico San Martino [174]Hokkaido University Hospital [175]St. Marianna University Hospital [176]NHO Nagoya Medical Center [177]NHO Osaka Minami Medical Center [178]Kanazawa University Hospital [179]Osaka University Hospital [180]Japanese Red Cross Okayama Hospital [181]Tohoku University Hospital [182]Teikyo University Hospital [183]Niigata University Medical &amp [184]University of Fukui Hospital [185]Yokohama City University Hospital [186]Takatsuki Red Cross Hospital [187]JCHO Chukyo Hospital [188]Wakayama Medical University Hospital [189]Kumamoto University Hospital [190]Kindai University Hospital [191]Kita Harima Medical Center [192]Shiga University of Medical Science Hospital [193]Showa University East Hospital [194]Juntendo University Urayasu Hospital [195]Shimane University Hospital [196]Hospital of the University of Occupational and Environmental Health [197]NHO Yokohama Medical Center [198]Nagasaki University Hospital [199]Kakogawa Central City Hospital [200]Severance Hospital, Yonsei University Health System [201]Hanyang University Seoul Hospital [202]Chonnam National University Hospital [203]The Catholic University of Korea, Seoul St. Marys Hospital [204]Korea University Ansan Hospital [205]Centro de Investigacion Clínica GRAMEL S.C [206]Consultorio Privado Dr. Miguel Cortes Hernandez [207]Derma Norte del Bajio S.C. [208]Medical Care &amp [209]Investigacion y Biomedicina de Chihuahua, S.C. [210]Centro Regiomontano de Estudios Clínicos Roma S.C. [211]Centro de investigacion medica y reumatologia [212]Clinstile, S.A. de C.V. [213]Invest Clinicas Sac Inst de Ginecologia y Reproduccion [214]Clinica San Felipe - Centro de Investigacion Clinica Inmunoreumatologia [215]Far Eastern University - Dr. Nicanor Reyes Medical Foundation [216]Mary Mediatrix Medical Center [217]Philippine General Hospital [218]Medical Center Manila [219]Cebu Doctors University Hospital [220]St. Lukes Medical Center [221]Jose R. Reyes Memorial Medical Center [222]The Medical City Clark [223]Ilocos Training and Regional Medical Center [224]Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski [225]Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A Lesiak [226]Ajou University Hospital [227]Keio University Hospital [228]Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spoika Partnerska [229]Royalderm [230]SPZOZ Szpital Uniwersytecki w Krakowie [231]Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina [232]Szpital Kliniczny Dzieciatka Jezus [233]Hospital CUF Descobertas [234]Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC) [235]Centro Hospitalar Universitártio do Porto, E.P.E. [236]Hospital de Egas Moniz [237]Unidade Local de Saude do Alto Minho, E.P.E. [238]Dr. Samuel Sanchez PSC [239]GCM Medical Group PSC - Hato Rey [240]King Saud University [241]King Faisal Specialist Hospital &amp [242]Institute of Rheumatology [243]Clinical Center of Vojvodina [244]University Clinical Center of Serbia [245]Narodny ustav reumatickych chorob [246]Artromac n.o. [247]Hospital Universitario Rio Hortega [248]Hospital Universitari Germans Trias i Pujol [249]Hospital de la Santa Creu i Sant Pau [250]Complejo Hospitalario Universitario A Coruna [251]Hospital Universitario Puerta de Hierro Majadahonda [252]Hospital Universitario Reina Sofia [253]Hospital Universitario Fundacion Alcorcon [254]Hospital Universitario Virgen del Rocio [255]Hospital del Mar [256]Karolinska Universitetssjukhuset - Solna [257]Centre Hospitalier Universitaire Vaudois (CHUV) [258]Kantonsspital St. Gallen [259]Universitaetsspital Zuerich

研究目的:
评估 BIIB059(Litifilimab)在有或无全身表现且抗疟治疗反应不佳和/或不耐受的活动性亚急性 CLE 和/或慢性 CLE 受试者中的长期安全性和耐受性。

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