Multiple Sclerosis
Conditions
Interventions
Observation group:None
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-65 years, any gender; 2.Meet the diagnostic criteria for Relapsing Multiple Sclerosis (MS); 3.About to initiate or currently receiving standard regimen of ofatumumab; 4.Able to understand and voluntarily sign the written informed consent form;
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to ofatumumab or any of its excipients; 2.Presence of a concurrent severe infection, active hepatitis, tuberculosis, or other significant infectious diseases; 3.Pregnant or lactating women; 4.Use of any biologic agent other than ofatumumab (OFA) or rituximab (RTX) for the treatment of a disease relapse; 5.Patients with an active malignancy who are currently receiving chemotherapy; 6.Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study; 7.Any other situation for which, in the clinical judgment of the treating physician, participation would be inappropriate;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Expanded Disability Status Scale (EDSS) Score;Change from Baseline in Fatigue Severity Scale (FSS) Score;Change from Baseline in Multiple Sclerosis Quality of Life-54 (MSQOL-54) Score;Correlation between Biomarker Dynamics and Clinical Improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dynamic Change in Serum Neurofilament Light Chain (sNfL) Level;Changes in Brain and Spinal Cord Magnetic Resonance Imaging (MRI) Lesions;Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs);Activities of Daily Living (ADL) Score;Dynamic Change in Peripheral Blood CD19+ B-cell Count;Annualized Relapse Rate and Time to First Relapse; | — |
Countries
China
Contacts
Public ContactGuo Shougang
Shandong Provincial Hospital
Outcome results
None listed