To clarify the efficacy and safety of protein A immunoadsorption therapy for acute exacerbations of neuromyelitis optica spectrum disorders(NMOSD), we designed a multicenter, open-label, superiority randomized controlled clinical trial, planning to enroll 144 patients with NMOSD. We plan to treat patients with acute NMOSD using protein A immunoadsorption combined with high-dose intravenous methylprednisolone, and compare this with treatment using high-dose intravenous methylprednisolone alone. The aim is to observe the impact and safety of protein A immunoadsorption on the treatment efficacy for these patients experiencing acute exacerbations of NMOSD, ultimately providing more comprehensive clinical evidence to support treatment protocols for the acute phase of NMOSD.
clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD)
Age and Gender: Participants must be between 18 and 65 years old, inclusive, with no gender restrictions.
Serological Marker: Participants must test positive for AQP4-IgG using the cell-based assay (CBA) method.
Understanding and Consent: Participants or their legal representatives must be able to understand the study's purpose, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.
Women who are pregnant or breastfeeding.
Participants who cannot establish peripheral or central venous access, or have a history of allergic reactions to plasmapheresis.
Participants with contraindications to intravenous methylprednisolone treatment.
Participants who have used monoclonal antibodies in the last 6 months, or FcRn antagonists in the last 3 months.
Third Affiliated Hospital, Sun Yat-Sen University
Lead sponsor
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
Guangdong 999 Brain Hospital
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
Beijing Friendship Hospital
Collaborator