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一项在中度至重度活动性系统性红斑狼疮研究受试者中评价dapirolizumab pegol的有效性和安全性的研究

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研究单位: [1]中国医学科学院北京协和医院 [2]中山大学附属第三医院 [3]南京医科大学第一附属医院(江苏省人民医院) [4]西安交通大学第一附属医院 [5]山东大学齐鲁医院 [6]苏州大学附属第一医院 [7]天津医科大学总医院 [8]北京大学第一医院 [9]复旦大学附属华山医院 [10]桂林医学院附属医院 [11]新疆维吾尔自治区人民医院 [12]温州医科大学附属第一医院 [13]吉林大学第一医院 [14]郑州大学第一附属医院 [15]华中科技大学同济医学院附属同济医院 [16]华中科技大学同济医学院附属协和医院 [17]蚌埠医学院第一附属医院 [18]复旦大学附属中山医院 [19]上海交通大学医学院附属仁济医院 [20]常州市第一人民医院 [21]内蒙古科技大学包头医学院第一附属医院 [22]中山大学孙逸仙纪念医院 [23]北京大学第三医院 [24]南昌大学第二附属医院 [25]苏北人民医院 [26]中南大学湘雅医院 [27]海南省人民医院 [28]浙江省人民医院 [29]江西省萍乡市人民医院 [30]Aprillus Asistencia e Investigacion Clinica [31]Instituto Medico CER [32]Hospital Jose Maria Ramos Mejia [33]Centro de Investigaciones Medicas Tucuman [34]Instituto de Investigaciones Clinicas Quilmes [35]Hospital Cordoba - Reumatology [36]Instituto de Reumatologia - Borgia Alfredo Luis [37]Ordensklinikum Linz GmbH - Dermatology [38]AKH Wien [39]LKH-Univ. Klinikum Graz [40]CHU de Liege - Domaine Universitaire du Sart Tilman [41]Hopital Erasme [42]CHU Brugmann - Victor Horta [43]Toronto Western Hospital [44]Centre integre de sante et de services sociaux du Bas-Saint-Laurent (CISSSBSL) Hopital regional de Rimouski - Research [45]Mcgill Univ Health Center [46]University Of Alberta Hospital [47]University of Calgary [48]Clinica Dermacross,S.A [49]Centro Medico Prosalud [50]INTERIN [51]Biomedica Research Group [52]Rigshospitalet Copenhagen University Hospital [53]CHU Hopital de Hautepierre [54]AP-HP [55]Hopital Lapeyronie - Departement de Rhumatologie po [56]Centre Hospitalier Universitaire De Bordeaux - Hopital Saint - Medecine Interne Et Des Maladi [57]Hopital Pellegrin [58]St. Elisabeth Gruppe GmbH - Katholische Kliniken Rhein- Ruhr,Rheumazentrum Ruhrgebiet [59]Universitatsklinikum Freiburg [60]Universitatsklinikum Leipzig AoR [61]Universitatsmedizin der Johannes-Gutenberg-Universitat Mainz [62]Stadtisches Klinikum Dessau [63]Universitatsklinikum Carl Gustav Carus [64]Universitatsklinikum Koln [65]CIRI GmbH [66]Schlosspark-Klinik - Zentrum fur Rheumaforschung [67]Ippokrateio Hospital of Thessaloniki [68]Laikon [69]University Hospital of Crete PAGNI [70]Hippokration Hospital Athens [71]University of Patras - Rio Regional University Hospital [72]General Hospital of Athens [73]University Hospital Of Larissa [74]Queen Mary Hospital - Medicine [75]PO S.Marco,AOU Policlinico-Vittorio Emanuele Catania [76]Polo Universita degli Studi di Milano - Ospedale Luigi Sacco [77]Policlinico Universitario Gemelli [78]AOU Pisana [79]Policlinico di Milano [80]Ospedale San Raffaele,IRCCS [81]AO G.Pini,Istituto Ortopedico [82]Arcispedale S.Anna,AOU di Ferrara [83]Policlinico G. B. Rossi [84]AOU di Padova [85]DiMI,Dipartimento di Medicina interna e Specialita mediche, [86]Ajou University Hospital - Rheumatology [87]Seoul National University Hospital - Rheumatology [88]Dong-A University Hospital [89]Unidad de Investigacion de Reumatologia e Inmunologia CSJB [90]Instituto de Ginecología y Reproduccion [91]Hospital Nacional Cayetano Heredia [92]Instituto Peruano del Hueso y la Articulación [93]Hogar Clínica San Juan de Dios. Unidad de Investigacion en M [94]Medycyna Kliniczna [95]Reumatika-Centrum Reumatologii,NZOZ [96]Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie [97]Narodowy Instytut Geriatrii,Reumatologii i Rehabilitacji [98]Centrum Medyczne Pratia Katowice [99]Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego [100]Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. W. Degi UM w Poznaniu [101]Pratia MCM Krakow [102]Centrum Medyczne Plejady [103]C.H. de Vila Nova de Gaia/Espinho [104]H. Conde de Bertiandos. Centro Hospitalar do Alto Minho [105]Centro Hospitalar de Leiria [106]Hospitais Da Universidade de Coimbra [107]H. Santa Maria. Centro Hospitalar Lisboa Norte [108]Clinical Center Of Vojvodina [109]Institute for Rheumatology [110]Military Medical Academy [111]Clinical Center Kragujevac [112]C.H.U. A Coruna [113]Hospital Universitario Vall d'Hebron [114]H. Civil de Malaga [115]H.U.V.Arrixaca [116]Hospital Quironsalud Sagrado Corazo [117]Hospital Universitario de Canarias [118]Hospital de Merida [119]Taipei Veterans General Hospital - Allergy,Immunology and Rheuma [120]Tri-Service General Hospital - Neihu Branch - Rheumatology [121]Taichung Veterans General Hospital [122]The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit [123]Guy's and St Thomas NHS Trust [124]University College London Hospitals [125]West Tennessee Research Institute [126]NYU Langone Ambulatory Care Brooklyn Heights [127]Klein & Associates,M.D.,P.A. [128]Altoona Center for Clinical Research - Research [129]Southwest Rheumatology Research LLC [130]Arizona Arthritis & Rheumatology Research,PLLC - Rheumatology [131]Metroplex Clinical Research Center [132]Arthritis Northwest,PLLC [133]Hospital for Special Surgery [134]University of Alabama at Birmingham [135]Penn State Milton S Hershey Medical Center Pediatrics [136]Wake Forest School of Medicine - Department of Rheumatology [137]Wayne State University / Detroit Receiving Hospital [138]DJL Clinical Research,PLLC [139]Bay Area Arthritis And Osteoporosis [140]Institute of Arthritis Research [141]SUNY Upstate Medical University [142]Bronx-Lebanon Hospital Center [143]University of California San Diego School of Medicine [144]Academic Medical Research Institute (AMRI) [145]Oklahoma Medical Research Foundation [146]Amarillo Center for Clinical Research,Ltd. [147]The Feinstein Institute for Medical Research [148]Northwell Health/ Division of Rheumatology [149]University Of Washington Medical Ctr [150]Innovative Health Research [151]Arthritis & Osteoporosis Medical Center,Inc. - La Palma [152]Childrens Hospital Los Angeles [153]Graves-Gilbert Clinic - Bowling Green [154]Accurate Clinical Research,Inc. [155]Klein and Associates,M.D.,P.A. [156]UT Southwestern Medical Center [157]Rush University Medical Center [158]Duke Medical Center [159]East Bay Rheumatology Medical Group,Inc. [160]University of California San Diego [161]West Virginia University Hospitals [162]Arthritis and Rheumatology Center of Oklahoma,PLLC [163]Intergral Rheumatology & Immunology Specialist [164]Center for Arthritis and Rheumatic Diseases [165]AA Medical Research Center LLC [166]Columbia University Medical Center [167]Mt. Olympus Medical Research [168]Denver Arthritis Clinic [169]University of California,Irvine [170]Howard University Hospital [171]Clinic of Robert Hozman [172]Kaiser Permanente [173]UF Health Rheumatology [174]The Children's Hospital of Philadelphia (CHOP) [175]Thomas Jefferson University [176]UPMC [177]St. Lawrence Health System Medical Campus [178]Yale Center for Clinical Investigation - Delivery [179]EMORY UNIVERSITY [180]TriWest Research Associates,LLC. [181]Loma Linda University - Rheumatology [182]Piedmont Healthcare [183]Wallace Rheumatic Studies Center [184]Precision Comprehensive Clinical Research Solutions [185]Rheumatology Associates of Central Florida [186]Arthritis and Rheumatic Disease Specialties - Rheumatology [187]Western KY Rheumatology,PLLC [188]University of Miami Miller School of Medicine - Department o [189]University of Fukui Hospital [190]Osaka University Hospital [191]Manabu Fujimoto [192]Mie University Hospital - Rheumatology [193]Nippon Medical School Hospital - Dermatology [194]National Hospital Organization Nagoya Medical Center - Hematology [195]Nagasaki University Hospital - Rheumatology [196]Eiraku Clinic - Rheumatology [197]Toho University Medical Center Ohashi Hospital - Rheumatology [198]Hospital of the University of Occupational and Environmental Health [199]Saitama Medical University Saitama Medical Center - Rheumatology/Collagen disease [200]Hamanomachi Hospital - Rheumatology [201]Kyushu Medical Center - Rheumatology [202]Kitasato University Hospital Rheumatology and Infectious Diseases [203]Kagawa University Hospital - Internal Medicine [204]Saga University Hospital - Rheumatology [205]Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital - Rheumatology [206]The University of Tokyo Hospital - Allergy and Rheumatology [207]Tokyo Women's Medical University Hospital [208]St. Luke's International Hospital - Dermatology [209]Juntendo University Hospital [210]Kurashiki Medical Center - Rheumatology [211]JCHO Chukyo Hospital - Dermatology [212]Keio University Hospital - Rheumatology [213]Sasebo Chuo Hospital - Internal Medicine [214]National Center for Global Health and Medicine - Rheumatology [215]Osaka University Hospital -Rheumatology [216]Hokkaido University Hospital

研究目的:
评价使用DZP作为标准治疗药物的辅助治疗是否能够长期改善中重度疾病活动度的临床相关症状 评价使用DZP作为标准治疗药物的辅助治疗是否能够快速改善中重度疾病活动度的临床相关症状 评价使用DZP作为标准治疗药物的辅助治疗是否能够长期控制疾病活动度 评价使用DZP作为标准治疗药物的辅助治疗是否能够实现和维持治疗达标目的:使用低/可接受剂量的皮质类固醇即可长期保持低疾病活动度 评价使用DZP作为标准治疗药物的辅助治疗是否能够改善疾病活动度(通过临床实践中常用的疾病状态数值评分量表进行判定) 评价使用DZP作为标准治疗药物的辅助治疗是否能够达到复合主要终点各组成部分的评分改善 评价使用DZP作为标准治疗药物的辅助治疗是否能够达到替代终点应答 评价使用DZP作为标准治疗药物的辅助治疗是否能够达到对其他关键次要终点提供支持的终点 评价使用DZP作为标准治疗药物的辅助治疗的安全性和耐受性

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