Ofatumumab treatment and blood neurofilament levels in relapsing multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Wei Qiu Ph.D
• Email: qiuwei120@vip.163.com
• Phone: +8615899968330

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.