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Exploring the Efficacy and Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis (RMS) and Its Impact on Serum Neurofilament Light Chain (sNfL) Levels

Recruitingn/aAges 18 Years - anyAllThird Affiliated Hospital, Sun Yat-Sen University
NCT07353216 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Multiple sclerosis (MS) is an immune-mediated disease characterized primarily by inflammatory demyelinating lesions in the central nervous system (CNS), with the white matter being predominantly affected. Its etiology remains unclear and may be associated with various factors such as genetics, environment, and viral infections . Pathologically, MS presents as multiple demyelinating lesions in the CNS, which may be accompanied by damage to nerve cells and their axons. Lesions on MRI show characteristic distributions, morphologies, and signal intensities . MS typically onset in young adults and is more common in women. Frequent symptoms include visual decline, diplopia, limb sensory disturbances, limb motor impairment, ataxia, and bladder or rectal dysfunction . As MS can lead to varying degrees of neurological deficits, and repeated relapses result in disability progression, it impacts pa

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📋 Eligibility rules (as published)
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). \- 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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What it tests

  • Ofatumumab
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Where

1 site
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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