A Multicentric, Retrospective, Real-Word Study to Evaluate the Efficacy and Safety of Inebilizumab Compare With Rituximab in Neuromyelitis Optica Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Change in Expanded Disability Status Scale Score (EDSS) from baseline.
研究概览
简要总结
To compare the safety and efficacy of Inebilizumab and Rituximab in neuromyelitis optica spectrum disorders (NMOSD) patients.
详细描述
Inebilizumab is a humanized anti-CD19 monoclonal antibody. CD19 is broadly expressed on B-lineage cells, particularly late-stage memory B-lymphocytes and plasma blasts. Inebilizumab depletes antibody-secreting plasmablasts and some plasma cells.
Rituximab (RTX) is a chimeric anti-CD20 monoclonal antibody that promotes B-lymphocyte depletion through antibody-dependent cellular cytotoxicity (ADCC)/complement-dependent cytotoxicity (CDC), promotes an immunoregulatory T-lymphocyte phenotype, and activates neutrophil/macrophage phagocytosis.
This is a retrospective, multicentre, real-world study which aims to compare Inebilizumab with RTX in neuromyelitis optica spectrum disorders patients. Eighty patients from 8 centres in China will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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).
- •Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the acute phase.
- •Patients have given their written informed consent.
排除标准
- •Lactating and pregnant females.
- •Participate in other interventional studies within 30 days or within 5 half-lives of the investigational agent before received inebilizumab and rituximab (RTX).
- •Receipt of any experimental B-cell depleting agent within 6 months prior inebilizumab and RTX, and B-cells below the lower limit of normal
- •Known history of a severe allergy or reaction to any component of the investigational product formulation.
- •Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization (including viral hepatitis, active tuberculosis or positive tuberculosis screening).
- •History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to treatment.
- •History of malignancies.
- •Combined with severe mental disorders and other conditions and unable to cooperate with follow-up.
研究组 & 干预措施
Exposed group 1
Intravenous methylprednisolone (IVMP) plus Inebilizumab
干预措施: Inebilizumab (Drug)
Exposed group 2
IVMP plus Rituximab (RTX)
干预措施: Rituximab(RTX) (Drug)
结局指标
主要结局
Change in Expanded Disability Status Scale Score (EDSS) from baseline.
时间窗: 12 months
Change in Expanded Disability Status Scale (EDSS) score from baseline to 12 months after treatment (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Time to first relapse
时间窗: 12 months
Relapse: A monophasic clinical episode with patient-reported symptoms and objective findings reflecting a focal or multifocal inflammatory demyelinating event in the central nervous system (CNS), developing acutely or subacutely, with a duration of at least 24h, without fever or infection.
Number of new, and/or enlarging T2- hyperintense lesions detected by Magnetic Resonance Imaging (MRI)
时间窗: 12 months
Number of new, and/or enlarging T2-hyperintense lesions detected by Magnetic Resonance Imaging (MRI) at the last visit.
次要结局
- Change in Expanded Disability Status Scale (EDSS) score from baseline(6 months)
- Change in modified Rankin score (mRS) from baseline(12 months)
- Change in serum glial fibrillary acidic protein antibody (GFAP-Ab) levels from baseline.(12 months)
- Change in serum Neurofilament light chain protein (NfL) levels from baseline.(12 months)
- Change in Visual Acuity (VA) from baseline(12 months)
- Percentage of Participants with Disability Improvement(12 months)
- Change in Timed 25 Foot Walk Test from baseline(12 months)
- Adverse reactions during treatment and follow-up(12 months)
- Percentage of Participants with Disability Worsening(12 months)
- Annual relapse rate (ARR) before and after Inebilizumab/Rituximab(12 months)
- Change in aquaporin 4 antibody (AQP4-Ab) titers from baseline.(12 months)
- Changes in The Five Level of EuroQol Five Dimensions Questionnaire (EQ-5D-5L) scores from baseline(12 months)
- Number of NMOSD attacked related rescue treatment.(12 months)
- Change in retinal nerve fiber layer (RNFL) loss from baseline(12 months)
研究者
Feng Jinzhou
Ph.D
First Affiliated Hospital of Chongqing Medical University