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Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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研究单位: [1]Janssen Research & Development, LLC [2]Keck School of Medicine of USC,Los Angeles,California,United States,90033 [3]Forbes Norris MDA/ALS Research and Treatment Center,San Francisco,California,United States,94115 [4]University of Colorado,Aurora,Colorado,United States,80045 [5]IMMUNOe Health and Research Centers,Centennial,Colorado,United States,80112 [6]Neurology Associates PA,Maitland,Florida,United States,32751 [7]Augusta University,Augusta,Georgia,United States,30912 [8]University of Kansas Medical Center,Kansas City,Kansas,United States,66160 [9]Johns Hopkins Hospital,Baltimore,Maryland,United States,21287 [10]Beaumont Hospital - Royal Oak,Royal Oak,Michigan,United States,48073 [11]The Neurological Institute of New York,New York,New York,United States,10032 [12]South Shore Neurologic Associates - Patchogue,Patchogue,New York,United States,11772 [13]The Neurological Institute, PA,Charlotte,North Carolina,United States,28204 [14]Atrium Health,Charlotte,North Carolina,United States,28207 [15]Duke University School of Medicine,Durham,North Carolina,United States,27710 [16]Cleveland Clinic Main Campus,Cleveland,Ohio,United States,44195 [17]Hospital of the University of Pennsylvania,Philadelphia,Pennsylvania,United States,19104 [18]Austin Neuromuscular Center,Austin,Texas,United States,78756 [19]Advocate Health - Aurora St. Luke&#39 [20]s Medical Center,Milwaukee,Wisconsin,United States,53215 [21]Hospital Gral Agudos Ignacio Pirovano,Buenos Aires,Argentina,C1428 [22]Hospital Italiano de Buenos Aires,Ciudad Autonoma de Buenos Aires,Argentina,C1199ABB [23]The Alfred Hospital,Melbourne,Australia,3004 [24]Gold Coast University Hospital,Parkwood,Australia,4215 [25]LKH - Universitätsklinikum Graz,Graz,Austria,8036 [26]Medizinische Universität Wien,Vienna,Austria,A-1090 [27]Hopital Erasme,Brussels,Belgium [28]Universitair Ziekenhuis Leuven,Leuven,Belgium,3000 [29]Centre Hospitalier Régional de la Citadelle,Liège,Belgium,4000 [30]Instituto de Neurologia de Curitiba,Curitiba,Brazil,81210-310 [31]Hospital Universitario Antonio Pedro - Universidades Federal Fluminense,Rio de Janeiro,Brazil,24033-900 [32]Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base,Sao Paulo,Brazil,04024-002 [33]DCC Convex EOOD,Sofia,Bulgaria,1680 [34]University of Alberta Hospital,Edmonton,Alberta,Canada,T6G 2X8 [35]London Health Sciences Centre,London,Ontario,Canada,N6A 5A5 [36]Toronto General Hospital,Toronto,Ontario,Canada,M5G 2C4 [37]Peking University First Hospital,Beijing,China,100034 [38]Xuanwu Hospital, Capital Medical University,Beijing,China,100053 [39]Beijing Tiantan Hospital, Capital Medical University,Beijing,China,100070 [40]Peking University Third Hospital,Beijing,China,100191 [41]The First Hospital of Jilin University,Changchun,China,130021 [42]The Third Xiangya Hospital of Central Sourth University,Changsha,China,410008 [43]Xiangya Hospital Central South University,Changsha,China,410008 [44]Chifeng Municipal Hospital,Chifeng,China,024000 [45]Fujian Medical University Union Hospital,Fuzhou,China,350001 [46]The First Affiliated Hospital, Sun Yat-sen University,Guang Zhou,China,510080 [47]Qianfoshan hospital of Shandong Province,Jinan,China,250014 [48]The First Affiliated Hospital of NanChang University,Nanchang,China,330006 [49]Shanghai Sixth People's Hospital,Shanghai,China,200233 [50]Tong Ren Hospital Shanghai Jiao Tong University school of medicine,Shanghai,China,200336 [51]Xi &#39 [52]an GaoXin Hospital,Xi'an,China,710075 [53]Henan province people's hospital,Zhengzhou,China,450003 [54]Hospital Universitario San Ignacio,Bogotá,Colombia,110231 [55]Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca,Floridablanca,Colombia,681004 [56]Instituto Neurológico de Colombia,Medellin,Colombia,50021 [57]Fakultni nemocnice Hradec Kralove,Hradec Králové,Czechia,500 05 [58]Fakultni nemocnice Ostrava,Ostrava,Czechia,708 52

研究目的:
The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.

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