Adult Relapsing-Remitting Multiple Sclerosis
Conditions
Interventions
Adult Relapsing-Remitting Multiple Sclerosis:Patients currently receiving or planned to receive dimethyl fumarate enteric-coated capsules in clinical practice.
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, gender not specified; 2.Diagnosed with multiple sclerosis according to the 2017 McDonald diagnostic criteria, including clinical isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or highly active secondary progressive multiple sclerosis (SPMS); 3.Currently using or planning to use dimethyl fumarate enteric capsules within the past month; 4.The participant or their legal representative is able to sign the informed consent form and comply with the study requirements, including medication administration and follow-up
Exclusion criteria
Exclusion criteria: 1.Diagnosed with primary progressive multiple sclerosis (PPMS) or radiologically isolated syndrome (RIS); 2.Presence of significant cardiovascular disease (including severe arrhythmias), liver, kidney, respiratory, endocrine, or hematological diseases, or malignancies, or other medical conditions that the investigator deems may impede participation in the study; 3.Positive for any of the following: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), hepatitis B core antibody (HBcAb), or hepatitis B DNA positive; positive for hepatitis C virus antibody (HCVAb); positive for syphilis serology; or positive for HIV antibody; 4.Inability to accurately recall the disease course or medication history; 5.Currently participating in other clinical drug trials; 6.Concomitant use of other immunomodulators or immunosuppressants; 7.Pregnant, lactating, or planning to become pregnant within the next 3 months; 8.Contraindication to magnetic resonance imaging (MRI) or inability to complete the MRI examination; 9.The investigator deems the participant unsuitable for participation in the study (e.g., severe psychiatric disorders)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The annual relapse rate at Week 96 +/- 2 weeks.;The change in the number of new T1 hypointense lesions from baseline at Weeks 48 +/- 1 and 96 +/- 2; | — |
Secondary
| Measure | Time frame |
|---|---|
| The annual relapse rate at Week 48 +/- 1 week;The proportion of participants achieving NEDA-3 at Weeks 48 +/- 1 and 96 +/- 2;The proportion of participants with disability progression confirmed at Weeks 12 +/- 1 and 24 +/- 1;The incidence of adverse events during the treatment period;The change in the number of new or enlarged T2 hyperintense lesions from baseline at Weeks 48 +/- 1 and 96 +/- 2;The proportion of participants experiencing a relapse at Weeks 48 +/- 1 and 96 +/- 2;The change in Expanded Disability Status Scale (EDSS) score from baseline at Weeks 48 +/- 1 and 96 +/- 2;The change in the number of gadolinium-enhancing lesions from baseline at Weeks 48 +/- 1 and 96 +/- 2; | — |
Countries
China
Contacts
Public ContactHao Junwei
Xuanwu Hospital Capital Medical University
Outcome results
None listed