Study of Protein A Immunoadsorption Combined with Intravenous Methylprednisolone Compared to Methylprednisolone Alone for Acute Neuromyelitis Optica Spectrum Disorder in Adults

What this Trial Is About

Researchers are evaluating the effectiveness and safety of protein A immunoadsorption therapy combined with high-dose intravenous methylprednisolone in treating acute exacerbations of neuromyelitis optica spectrum disorders NMOSD. This multicenter, open-label, randomized trial plans to enroll 144 patients to compare this combination treatment with high-dose intravenous methylprednisolone alone. The aim is to provide more comprehensive clinical evidence to improve treatment protocols for the acute phase of NMOSD. Participants in the experimental group will receive protein A immunoadsorption treatments every other day for a total of five sessions, each involving plasma regeneration of 1 to 3 times the plasma volume, alongside a methylprednisolone regimen starting with 1g daily for 5 days and tapering down over 11 days. Patients in the control group will receive only the methylprednisolone regimen. After these treatments, all participants will be given oral immunosuppressants, either azathioprine or mycophenolate mofetil. During the study, participants will be closely monitored, with their disability status assessed using the Kurtzke Expanded Disability Status Scale EDSS one month after treatment begins compared to baseline. Researchers will also observe safety and treatment impact throughout the trial. The total participation period includes treatment and follow-up assessments to evaluate the therapys effects on NMOSD.

Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder