Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases (OMNISCIENCE)

Tianjin Medical University

Status: Enrolling

Conditions: Multiple Sclerosis; Neuromyelitis Optica Spectrum Disorder; Demyelinating Diseases of the Central Nervous System

Treatments: Drug: Ofatumumab

Study type: Observational

Funder types: Other

Identifiers

NCT05414487

COMB157GCN02T

Details and patient eligibility

About

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.

Full 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).

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent
2. RRMS subtype according to 2017 McDonald diagnostic criteria
3. Diagnosis of NMOSD according to the 2015 International Panel diagnostic criteria for NMOSD with AQP4-IgG
4. Newly diagnosed with MS/NMOSD and initiating ofatumumab treatment within the next 3 months

Exclusion criteria

1. Hypersensitivity to trial medications
2. History of life-threatening reaction to Ofatumumab
3. Acute or uncontrolled chronic medical condition
4. Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide, claridbine, etc.)
5. Impaired hearing
6. Claustrophobia
7. 300 lbs of greater (weight limit of MRI table)
8. Pregnancy or breastfeeding
9. Sensitivity to imaging agents
10. Contraindications to MRI
11. Use of benzodiazepines, topiramate, doxycycline, mynocicline

Trial design

34 participants in 1 patient group

Ofatumumab

Description:

17 RMS patients and 17 NMOSD patients prescribed with Ofatumumab will be enrolled after informed consent.

Treatment:

Drug: Ofatumumab