NCT05891379尚未招募不适用
Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Expanded Disability Status Scale (EDSS) score from baseline
研究概览
简要总结
This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.
详细描述
This is a a multicentric, prospective, real word study of inebilizumab in NMOSD acute attack compared with oral immunosuppressant. A total of 50 patients will be enrolled at approximately 10 centers around China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis);
- •In the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before screening, lasting at least 24 hours without with fever);
- •Patients who plan to receive or are receiving intravenous methylprednisolone therapy;
- •Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the screening period;
- •Able and willing to give written informed consent;
- •Women of childbearing potential who agree to use adequate contraception during the study.
排除标准
- •Lactating and pregnant females;
- •Participate in other interventional studies within 30 days before screening or within 5 half-lives of the investigational agent before enrollment;
- •Combined with severe mental disorders and other conditions and unable to cooperate with follow-up;
- •History of malignancies;
- •Received plasma exchange, immunoadsorption or intravenous immunoglobulin therapy within 1 month before screening;
- •Patients with negative hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, or patients with active tuberculosis or positive tuberculosis screening without appropriate treatment history;
- •Other situations that researchers think are not suitable to participate in this study.
研究组 & 干预措施
Exposed group
intravenous Intravenous methylprednisolone (IVMP) plus intravenous inebilizumab
干预措施: Inebilizumab (Drug)
Non-exposed group
IVMP plus oral immunosuppressant (Mycophenolate Mofetil or Azathioprine)
干预措施: oral immunosuppressant (Drug)
结局指标
主要结局
Change in Expanded Disability Status Scale (EDSS) score from baseline
时间窗: 6 months
Change in Expanded Disability Status Scale (EDSS) score from baseline at the last visit(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
次要结局
- Percentage of Participants With Disability Improvement(6 months)
- Change in modified Rankin score (mRS) from baseline(1 months, 3 months, 6 months)
- Change in serum GFAP levels from baseline(6 months)
- Change in Timed 25 Foot Walk Test from baseline(1 months, 3 months , 6 months)
- Number of NMOSD attacked related rescue treatment(6 months)
- Change in AQP4-ab titers from baseline(6 months)
- Change in Low-contrast Visual Acuity (LCVA) from baseline(3 months, 6 months)
- Changes in EQ-5D-5L scores from baseline(1 month, 3 months ,6 months)
- Change in Expanded Disability Status Scale (EDSS) score from baseline(1 months, 3 months)
- Time to first relapse(6 months)
- Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI)(6 months)
- Change in retinal nerve fiber layer (RNFL) loss from baseline(3 months ,6 months)
研究者
研究点 (1)
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