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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05414487 on ClinicalTrials.gov