[Translation] A multicenter, post-marketing study of dimethyl fumarate enteric-coated capsules (Tecfidera; BG00012) in Chinese subjects with relapsing forms of multiple sclerosis (RMS)
主要目的:评估第48周时富马酸二甲酯肠溶胶囊(DMF)在中国复发型多发性硬化(RMS)受试者中的有效性。
次要目的:评估富马酸二甲酯肠溶胶囊(DMF)在中国复发型多发性硬化(RMS)受试者中的有效性。评估富马酸二甲酯肠溶胶囊(DMF)在中国复发型多发性硬化(RMS)受试者中的安全性。
探索性目的:评估富马酸二甲酯肠溶胶囊(DMF)对中国复发型多发性硬化(RMS)受试者健康相关生活质量的影响。
[Translation] Primary objective: To evaluate the efficacy of dimethyl fumarate enteric-coated capsules (DMF) in Chinese subjects with relapsing multiple sclerosis (RMS) at week 48.
Secondary objective: To evaluate the efficacy of dimethyl fumarate enteric-coated capsules (DMF) in Chinese subjects with relapsing multiple sclerosis (RMS). To evaluate the safety of dimethyl fumarate enteric-coated capsules (DMF) in Chinese subjects with relapsing multiple sclerosis (RMS).
Exploratory objective: To evaluate the effect of dimethyl fumarate enteric-coated capsules (DMF) on health-related quality of life in Chinese subjects with relapsing multiple sclerosis (RMS).