Rescue immunoadsorption treatment for neuromyelitis optica spectrum disorder attacks unresponsive to intravenous methylprednisolone.
Rui Li, Jingqi Wang, Cong Li...
https://pubmed.ncbi.nlm.nih.gov/33992860Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06763848
Protein A Immunoadsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder: A Multicenter, Open-label, Superiority, Randomized Trial
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2025-04-30
144
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Third Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor
S
Second Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsor
AI-Summary
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 therapy's effects on NMOSD.
CONDITIONS
Brief Title
Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD)
- Age between 18 and 65 years old
- Positive test for AQP4-IgG antibodies using the cell-based assay method
- Ability to understand the study purpose and comply with study protocols
- Signed informed consent form by participant or legal representative
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Unable to establish peripheral or central venous access
- History of allergic reactions to plasmapheresis
- Contraindications to intravenous methylprednisolone treatment
- Use of monoclonal antibodies in the last 6 months
- Use of FcRn antagonists in the last 3 months
- Need to use ACE inhibitors within 1 week before treatment or during the study and cannot stop
- Severe bleeding or bleeding disorders
- Severe heart failure
- Severe infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 11 days
Participants receive either protein A immunoadsorption combined with intravenous methylprednisolone or intravenous methylprednisolone alone to treat acute episodes of Neuromyelitis Optica Spectrum Disorder. Protein A immunoadsorption is administered every other day for a total of 5 treatments, while methylprednisolone follows a decreasing dose regimen over 11 days.
5 treatment sessions for immunoadsorption every other day and daily methylprednisolone infusions for 11 days
Follow-up
Duration - 1 month after treatment start
Participants are monitored one month after the start of treatment to evaluate changes in disability status compared to baseline.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 518000
Actively Recruiting
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Research Team
W
Wei Qiu, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Neuromyelitis optica: Evaluation of 871 attacks and 1,153 treatment courses.
Ingo Kleiter, Anna Gahlen, Nadja Borisow...
https://pubmed.ncbi.nlm.nih.gov/26537743Apheresis therapies for NMOSD attacks: A retrospective study of 207 therapeutic interventions.
Ingo Kleiter, Anna Gahlen, Nadja Borisow...
https://pubmed.ncbi.nlm.nih.gov/30345331Update on the diagnosis and treatment of neuromyelitis optica: recommendations of the Neuromyelitis Optica Study Group (NEMOS).
Corinna Trebst, Sven Jarius, Achim Berthele...
https://pubmed.ncbi.nlm.nih.gov/24272588A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis.
Vanda A Lennon, Dean M Wingerchuk, Thomas J Kryzer...
https://pubmed.ncbi.nlm.nih.gov/15589308International consensus diagnostic criteria for neuromyelitis optica spectrum disorders.
Dean M Wingerchuk, Brenda Banwell, Jeffrey L Bennett...
https://pubmed.ncbi.nlm.nih.gov/26092914