A Multicenter, Open-label, Single Group, Phase 4 Study to Evaluate Dimethyl Fumarate Enteric-coated Capsules in Relapsing Multiple Sclerosis (RMS)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Annualized Relapse Rate at Week 48
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety] in [subjects diagnosed with RMS according to the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).
The main questions it aims to answer are:
[Question 1] The efficacy of dimethyl fumarate enteric-coated capsules in the treatment of RMS.
[Question 2] The safety of dimethyl fumarate enteric-coated capsules in the treatment of RMS.
Participants will:
Eligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks.
The annualized relapse rate (ARR) at Week 48 will be observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed RMS per the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS)
- •At least one documented relapse within 12 months prior to screening; plus evidence of MS-consistent lesions on prior brain MRI or gadolinium-enhancing (GdE) lesions on an MRI performed within 6 weeks before screening
- •Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0 (inclusive) at screening
排除标准
- •History or current diagnosis of malignancy (except fully resected basal cell carcinoma), or uncontrolled severe diseases of major organ systems (e.g., cardiac, renal, hepatic, neurological [excluding multiple sclerosis]) that, in the investigator's assessment, pose a significant risk to the subject or could confound study results.
- •Protocol-defined multiple sclerosis (MS) relapse within 30 days prior to screening, or failure to achieve clinical stability from a prior relapse.
- •History of suicidal behavior within 5 years prior to screening. Suicidal ideation (indicated by a "Yes" response to Item 4 or 5 on the C-SSRS) within 6 months prior to screening.Subjects with a history of suicidal behavior occurring >5 years prior to screening require investigator assessment of eligibility.
研究组 & 干预措施
Dimethyl Fumarate Group
干预措施: Dimethyl Fumarate Enteric-coated Capsules (Drug)
结局指标
主要结局
Annualized Relapse Rate at Week 48
时间窗: 48 weeks
The primary efficacy endpoint is the annualized relapse rate (ARR), calculated as total relapses divided by total patient-years of observation, measured at Week 48
次要结局
未报告次要终点