Ofatumumab treatment and blood neurofilament levels in relapsing multiple sclerosis

Exploring the Efficacy and Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis (RMS) and Its Impact on Serum Neurofilament Light Chain (sNfL) Levels：A Multicenter, Open-Label, Observational Real-World Study

This observational study will try ofatumumab in adults with relapsing MS to see if it is safe and whether blood neurofilament light chain (sNfL) levels change.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Drugs / interventions: ofatumumab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07353216 on ClinicalTrials.gov

What this trial studies

This is an observational cohort of adults with relapsing multiple sclerosis who are receiving ofatumumab as part of clinical care, with prospective monitoring of safety and serum neurofilament light chain (sNfL). Eligible participants meet the 2017 Revised McDonald Criteria and have an EDSS between 0 and 7, and they agree to regular MRI monitoring and serial blood draws. Participants will undergo scheduled clinical assessments, MRI scans, and blood sampling for sNfL, with adverse events and laboratory abnormalities recorded. The study is run by the Third Affiliated Hospital of Sun Yat-sen University with collaborating hospitals in Shenzhen and visits are conducted at the Guangzhou site.

Who should consider this trial

Good fit: Adults (≥18 years) with relapsing MS by the 2017 McDonald Criteria, EDSS 0–7, willing to undergo regular MRI, blood draws, and clinical assessments, and able to provide informed consent are appropriate candidates.

Not a fit: Patients with progressive MS phenotypes, pregnancy, active severe infections (e.g., hepatitis B, HIV), known hypersensitivity to ofatumumab, PML, recent malignancy, or other major comorbidities are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could help confirm the safety profile of ofatumumab in routine care and show whether sNfL reliably reflects treatment-related neuronal injury or improvement.

How similar studies have performed: Previous randomized trials of ofatumumab in relapsing MS have shown reductions in relapse rates and brain lesions, and other studies have reported that anti-CD20 therapies can lower sNfL, so the approach has clinical and biomarker precedent.

Eligibility criteria

Inclusion Criteria:Signed and dated informed consent must be obtained before participation in the study.

Any gender, aged at least 18 years at the time of study enrollment (signing the informed consent form).

Patients with RMS meeting the 2017 Revised McDonald Criteria. EDSS score between 0 and 7. Regular follow-up with MRI monitoring. Willingness to provide blood samples. Willingness to undergo clinical assessments (including scales and physical examinations).

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Exclusion Criteria:Decision by the subject/legal guardian . Pregnancy. Diagnosis of Progressive Multifocal Leukoencephalopathy (PML). Hypersensitivity reaction to the investigational drug. Protocol violation that poses a significant safety risk to the subject. Occurrence of certain adverse events, such as malignancy, hepatic failure, or severe chronic infections (e.g., active hepatitis B, HIV).

Any laboratory abnormality that, considering the subject's overall condition, is deemed to prevent the subject's continued participation in the study.

Any condition that may pose a safety risk due to participation in the study. Non-compliance with the administration of the investigational drug or study procedures

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Where this trial is running

Guangzhou, Guangdong

• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Wei Qiu Ph.D

Conditions Multiple Sclerosis; NfL, Multiple sclerosis, treatment