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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.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dimethyl Fumarate Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimethyl Fumarate Enteric-coated Capsules | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate at Week 48 | 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 | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junwei Hao, doctor | Contact | 010-83198082 | haojunwei@vip.163.com |
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