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

Condition(s) studied

Investigational drug(s) / intervention(s)

Protein A immunoadsorption: 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.

intravenous methylprednisolone: 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.

Study 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

Primary outcome measure(s)

• To assess the effectiveness of the treatment, the change in the Kurtzke Expanded Disability Status Scale (EDSS) score is evaluated one month after the start of treatment compared to the baseline. The baseline is defined as the patient's condition before — Evaluation timing includes from the screening period to the baseline and the EDSS score assessment one month after starting treatment.
  To assess the effectiveness of the treatment, the change in the Kurtzke Expanded Disability Status Scale (EDSS) score is evaluated one month after the start of treatment compared to the baseline. The baseline is defined as the patient's condition before treatment began, or if the patient had not yet reached a plateau during the initial treatment phase and continued to worsen during hospitalization, the most severe stage during the current hospitalization is used as the baseline.The EDSS is a scale used for the objective and repeatable quantification of disability in patients, with scores ranging from 0 to 10. A score of 0 indicates normal function, while a score of 10 indicates death. An increase in the EDSS score reflects worsening symptoms.The method of evaluation involves calculating the EDSS score difference as follows: EDSS Score Difference = EDSS Score (Baseline) - EDSS Score (1 Month After Treatment Start).

Trial sites (1)

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