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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的主要目的是确定在被研究的非胸腺瘤性MG患者群体中，ETTX联合泼尼松治疗是否应该比单独使用强的松治疗更好。 次要目标： 次要目标是(I)通过记录它们对肌无力虚弱的影响来确定这些疗法的有效性，以及(Ii)通过记录总的强的松暴露情况以及通过记录试验的特定不良事件(TSAE)和不良症状(TSASS)来确定它们的安全性。重要的是，我们还将通过以下计划的分组分析来调查不同分组之间的结果是否有所不同： 1)在进入研究之前使用皮质类固醇与不使用皮质类固醇 2)男性与女性 (三)发病年龄在40岁以下和40岁以上的， (由于这些组在人类白细胞抗原分类和胸腺病理方面有记录的差异) 研究设计： 这项研究是一项多中心、单盲、随机、双臂治疗试验。受试者参与这项研究的时间最短为36个月，最长为51个月。

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.