Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases
NCT05414487 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 34
Last updated 2022-10-20
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) or Neuromyelitis optica spectrum disorder (NMOSD) after receiving ofatumumab treatment over an observational period of 12 months.
Conditions
- Multiple Sclerosis
- Neuromyelitis Optica Spectrum Disorder
- Demyelinating Diseases of the Central Nervous System
Interventions
- DRUG
-
Ofatumumab
There is no treatment allocation. Patients with MS or NMOSD administered Ofatumumab by prescription will be enrolled. Participants will receive 20mg ofatumumab (20 mg/0.4 ml) by subcutaneous injection. Ofatumumab is administrated at baseline, Day 7, Day 14 and monthly thereafter until the end of the study.
Sponsors & Collaborators
-
Tianjin Medical University General Hospital
lead OTHER
Principal Investigators
-
Chao Zhang, M.D., Ph.D. · Department of Neurology, Tianjin Medical University General Hospital
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-15
- Primary Completion
- 2023-12-01
- Completion
- 2024-06-01
- FDA Drug
- Yes
Countries
- China
Study Locations
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