Protein A Immunoadsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder：A Multicenter, Open-label, Superiority, Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Protein A immunoadsorption (Device)
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).
干预措施: intravenous methylprednisolone (Drug)
结局指标
主要结局
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
时间窗: 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).
次要结局
未报告次要终点
研究者
Wei Qiu
Chief Physician
Third Affiliated Hospital, Sun Yat-Sen University