CLINICAL TRIAL: THYMECTOMY IN NON-THYMOMATOUS MG PTS RECEIVING PREDINISONE

临床试验：接受泼尼松治疗的非胸腺瘤 MG PTS 中的胸腺切除术

• 批准号: 8166969
• 负责人: RUP TANDAN
• 金额: $ 0.17万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-01 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166969
• 关键词: Adrenal Cortex Hormones; Adverse event; Age; Age-Years; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Exposure to; Female; Funding; Grant; Institution; Onset of illness; Outcome; Pathology; Population Study; Prednisone; Randomized; Research; Research Design; Research Personnel; Resources; Safety; Source; Subgroup; Symptoms; Thymectomy; Treatment Efficacy; United States National Institutes of Health; arm; blind; male; patient population; 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: 1) Use of corticosteroids vs. none prior to entering the study 2) Male versus female 3) Age less than 40 years and age greater than40 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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项研究的主要目的是确定研究的非心心理MG患者群体研究的ETTX是否与泼尼松治疗相结合，仅应仅比单独的泼尼松治疗。 次要目标： 次要目标是（i）通过记录其对肌关系无力的影响，并通过记录其对泼尼松的全部暴露并记录试验特定的不良事件（TSAES）和不良症状（TSASS）来确定其对疗法的疗效。重要的是，我们还应研究通过以下计划的亚组分析在不同亚组之间的结果是否有所不同： 1）使用皮质类固醇在进行研究之前与无 2）男性与女性 3）年龄小于40岁，年龄大于40岁，疾病发病， （由于这些群体中HLA类别和胸腺病理学的差异） 研究设计： 这项研究是一项以上为中心的单一盲，随机，两臂治疗试验。受试者参与这项研究的持续时间至少为36个月，最多51个月。