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Design of a non-interventional post-marketing study to assess the long-term safety and effectiveness of ocrelizumab in German real world multiple sclerosis cohorts - the CONFIDENCE study protocol.

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第一作者： Petra,Dirks

第一单位： Roche Pharma AG, Emil-Barell-Straße 1, 79639, Grenzach-Wyhlen, Germany.

作者： Petra,Dirks ^[1] ; Vera,Zingler ^[2] ; Jost,Leemhuis ^[1] ; Heike,Berthold ^[1] ; Stefanie,Hieke-Schulz ^[1] ; David,Wormser ^[2] ; Tjalf,Ziemssen ^[3]

作者单位： Roche Pharma AG, Emil-Barell-Straße 1, 79639, Grenzach-Wyhlen, Germany. ^[1] F. Hoffmann-La Roche Ltd, Grenzacherstraße 124, 4070, Basel, Switzerland. ^[2] Universitätsklinikum Carl Gustav Carus, Zentrum für klinische Neurowissenschaften, Fetscherstr. 74, 01307, Dresden, Germany. tjalf.ziemssen@uniklinikum-dresden.de. ^[3]

关键词 Disease modifying therapy Long-term safety and effectiveness MSDS3 Non-interventional study Ocrelizumab Primary progressive multiple sclerosis Real world data Relapsing multiple sclerosis

医学主题词德国(Germany);人类(Humans);多发性硬化, 慢性进行性(Multiple Sclerosis, Chronic Progressive);多发性硬化, 复发缓解性(Multiple Sclerosis, Relapsing-Remitting);产品监测, 售后(Product Surveillance, Postmarketing);前瞻性研究(Prospective Studies);研究设计(Research Design)

DOI 10.1186/s12883-020-01667-7

PMID 32171264

发布时间 2020-08-03

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