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Dataset from Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis

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NIAID Data Ecosystem2026-05-02 收录
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https://doi.org/10.25934/PR00011077
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Primary Objective:To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing forms of multiple sclerosis as compared with baseline values and those of a reference population of untreated healthy subjects.Secondary Objectives:To assess if Teriflunomide treatment results in biased T cell clonal diversity. To assess the effect of Teriflunomide on the function of peripheral blood mononuclear cells (proliferation and cytokine production in situ).To assess the circulating cytokines profile in the serum of Relapsing Multiple Sclerosis (RMS) patients during a 24-week treatment versus baseline and healthy controls.To assess the reversibility of all parameter changes in patients who discontinue treatment after accelerated elimination procedure with cholestyramine or activated charcoal.

主要研究目的:对比基线指标与未接受治疗的健康受试者参照人群的对应数值,评估特立氟胺(Teriflunomide)对复发型多发性硬化患者淋巴细胞亚群的影响。次要研究目的:1. 评估特立氟胺治疗是否会引发T细胞克隆多样性偏态改变;2. 评估特立氟胺对外周血单个核细胞(peripheral blood mononuclear cells)原位增殖与细胞因子产生功能的影响;3. 对比基线水平与健康对照组,评估复发型多发性硬化(RMS)患者接受24周治疗期间血清中的循环细胞因子谱特征;4. 评估经考来烯胺或活性炭实施加速清除程序后停药的患者,其所有检测参数变化的可逆性。
创建时间:
2025-06-25
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