Protein A Immunoadsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder：A Multicenter, Open-label, Superiority, Randomised Trial
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• The inclusion criteria for the study are as follows:
‣ 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.
Locations
Other Locations
China
The Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Wei Qiu, Ph.D
qiuwei120@vip.163.com
+8615899968330
Time Frame
Start Date:2025-04-25
Estimated Completion Date:2026-12-31
Participants
Target number of participants:144
Treatments
Experimental: experimental group
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. Sequentially, the patients in this group were uniformly administered oral immunosuppressants, specifically azathioprine or mycophenolate mofetil (MMF).
Active_comparator: control group
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.Sequentially, the patients in this group were uniformly administered oral immunosuppressants, specifically azathioprine or mycophenolate mofetil (MMF).
Collaborators: Beijing Friendship Hospital, Guangdong 999 Brain Hospital, Second Xiangya Hospital of Central South University, Second Affiliated Hospital of Guangzhou Medical University
Leads: Third Affiliated Hospital, Sun Yat-Sen University