Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder
Protein A Immunoadsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder：A Multicenter, Open-label, Superiority, Randomised Trial
Third Affiliated Hospital, Sun Yat-Sen University
144 participants
Apr 25, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria8
- 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.
- Participants who must use ACE inhibitors (ACEI) within 1 week before the start of treatment or during the study, and cannot discontinue their use.
- Severe Bleeding or Bleeding Disorders
- Severe Heart Failure
- Severe Infections
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The experimental group was treated with a combination of protein A immunoadsorption and intravenous methylprednisolone. The methylprednisolone was administered following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day. Protein A immunoadsorption was conducted every other day, unless a physician determined that the patient's condition was unsuitable for treatment, in which case treatment was administered according to medical advice. A total of 5 treatments were given, with each session involving the regeneration of plasma at 1 to 3 times the plasma volume.
The control group was treated with intravenous methylprednisolone, following a regimen of 1g for 5 days, 0.5g for 3 days, 0.25g for 2 days, and 0.12g for 1 day.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06763848