Status:
UNKNOWN
Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases
Lead Sponsor:
Tianjin Medical University General Hospital
Conditions:
Multiple Sclerosis
Neuromyelitis Optica Spectrum Disorder
Eligibility:
All Genders
18-80 years
Brief Summary
This is an uncontrolled, prospective, observational cohort study to assess the function of meningeal lymphatic drainage and dynamics of immune cells in patients with relapsing multiple sclerosis (RMS)...
Detailed Description
This is an uncontrolled, prospective, observational cohort study in patients with RMS or NMOSD who will receive ofatumumab treatment over an observational period of 12 month. Ofatumumab was administra...
Eligibility Criteria
Inclusion
- Signed informed consent
- RRMS subtype according to 2017 McDonald diagnostic criteria
- Diagnosis of NMOSD according to the 2015 International Panel diagnostic criteria for NMOSD with AQP4-IgG
- Newly diagnosed with MS/NMOSD and initiating ofatumumab treatment within the next 3 months
Exclusion
- Hypersensitivity to trial medications
- History of life-threatening reaction to Ofatumumab
- Acute or uncontrolled chronic medical condition
- Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide, claridbine, etc.)
- Impaired hearing
- Claustrophobia
- 300 lbs of greater (weight limit of MRI table)
- Pregnancy or breastfeeding
- Sensitivity to imaging agents
- Contraindications to MRI
- Use of benzodiazepines, topiramate, doxycycline, mynocicline
Key Trial Info
Start Date :
October 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05414487
Start Date
October 15 2022
End Date
June 1 2024
Last Update
October 20 2022
Active Locations (1)
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1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052