Treatment for acute episodes of neuromyelitis optica spectrum disorder using protein A immunoadsorption

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of protein A immunoadsorption therapy in treating acute exacerbations of neuromyelitis optica spectrum disorders (NMOSD). It is a multicenter, open-label, superiority randomized controlled trial that plans to enroll 144 patients. Participants will receive either protein A immunoadsorption combined with high-dose intravenous methylprednisolone or high-dose intravenous methylprednisolone alone. The study seeks to provide comprehensive clinical evidence to support treatment protocols for NMOSD during acute phases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The inclusion criteria for the study are as follows:

  1. clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD)
  2. Age and Gender: Participants must be between 18 and 65 years old, inclusive, with no gender restrictions.
  3. Serological Marker: Participants must test positive for AQP4-IgG using the cell-based assay (CBA) method.
  4. 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 Criteria:

1. Women who are pregnant or breastfeeding.
2. Participants who cannot establish peripheral or central venous access, or have a history of allergic reactions to plasmapheresis.
3. Participants with contraindications to intravenous methylprednisolone treatment.
4. Participants who have used monoclonal antibodies in the last 6 months, or FcRn antagonists in the last 3 months.
5. Participants who must use ACE inhibitors (ACEI) within 1 week before the start of treatment or during the study, and cannot discontinue their use.
6. Severe Bleeding or Bleeding Disorders
7. Severe Heart Failure
8. Severe Infections

Where it's running

• The Third Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Wei Qiu, Ph.D
• Email: qiuwei120@vip.163.com
• Phone: +8615899968330

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.