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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的主要目的是确定在所研究的非胸腺瘤MG患者人群中，ETTX联合泼尼松治疗是否应首选泼尼松单药治疗。 次要目的： 次要目的是（i）通过记录治疗对肌无力的影响来确定治疗的疗效，（ii）通过记录泼尼松的总暴露量和记录试验特定不良事件（TSAE）和不良症状（TSAS）来确定其安全性。重要的是，我们还将通过以下计划的亚组分析研究不同亚组之间的结局是否存在差异： 1)入组研究前是否使用皮质类固醇 2)男性与女性 3)发病时年龄小于40岁且大于40岁， （因为这些组中HLA类别和胸腺病理学的记录差异） 研究设计： 本研究是一项多中心、单盲、随机、双臂治疗试验。受试者参与本研究的持续时间最短为36个月，最长为51个月。