Trials / Unknown
UnknownNCT05414487
Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases
Exploring the Effects of B Cell Depletion With Ofatumumab on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases - a Prospective Observational Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 34 (estimated)
- Sponsor
- Tianjin Medical University General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
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 administrated 20mg by subcutaneous injection on Days 1, 7 and 14 for initial loading, followed by monthly infusion up to 12 months. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) will be performed to assess meningeal lymphatic flow in participants before and after ofatumumab treatment.The change of immune cell landscape in RMS or NMOSD patients after receiving ofatumumab treatment will be monitored by mass cytometry (CyTOF). Assessments also include clinical assessments( clinical relapse rate and EDSS score) and MRI assessments (T2 lesion load, T1 gadolinium enhancing lesion number).
Conditions
- Multiple Sclerosis
- Neuromyelitis Optica Spectrum Disorder
- Demyelinating Diseases of the Central Nervous System
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-10-15
- Primary completion
- 2023-12-01
- Completion
- 2024-06-01
- First posted
- 2022-06-10
- Last updated
- 2022-10-20
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05414487. Inclusion in this directory is not an endorsement.