EFFECT OF THYMECTOMY IN NON-THYMOMATOUS MG PATIENTS ON PREDNISONE

胸腺切除术对非胸腺瘤重症肌无力患者的影响

• 批准号: 7605820
• 负责人: RUP TANDAN
• 金额: $ 0.08万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605820
• 关键词: Adrenal Cortex Hormones; Adverse event; Age; Class; Computer Retrieval of Information on Scientific Projects Database; Exposure to; Female; Funding; Grant; Institution; Onset of illness; Outcome; Pathology; Patients; Population Study; Prednisone; Randomized; Research; Research Design; Research Personnel; Resources; Safety; Source; Subgroup; Symptoms; Thymectomy; Treatment Efficacy; United States National Institutes of Health; Upper arm; blind; male; treatment trial

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of this study is to determine in the non-thymomatous MG patient population studied whether ETTX combined with prednisone therapy should be preferred to prednisone therapy alone. Secondary Objectives: The secondary objectives are (i) to determine the efficacy of the therapies by documenting their effects on myasthenic weakness and (ii) to determine their safety by documenting total exposure to prednisone and by recording the Trial Specific Adverse Events (TSAEs) and Adverse Symptoms (TSASs). Importantly, we shall also investigate whether outcomes vary between different subgroups by the following planned sub-group analyses: ¿ Use of corticosteroids vs. none prior to entering the study ¿ Male versus female ¿ Age 40 years at disease onset, (because of documented differences in HLA class and thymic pathology in these groups Study design: The study is a multi-centered, Single Blind, Randomized, two-armed treatment trial. The duration of a subject's participation in this study will be a minimum of 36 months and a maximum of 51 months.

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