Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Interventions
- Drug: Rituximab(RTX)
- Registration Number
- NCT06068829
- Lead Sponsor
- Feng Jinzhou
- Brief Summary
To compare the safety and efficacy of Inebilizumab and Rituximab in neuromyelitis optica spectrum disorders (NMOSD) patients.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
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- Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
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- Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the acute phase.
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- Patients have given their written informed consent.
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- Lactating and pregnant females.
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- Participate in other interventional studies within 30 days or within 5 half-lives of the investigational agent before received inebilizumab and rituximab (RTX).
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- Receipt of any experimental B-cell depleting agent within 6 months prior inebilizumab and RTX, and B-cells below the lower limit of normal
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- Known history of a severe allergy or reaction to any component of the investigational product formulation.
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- 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).
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- History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to treatment.
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- History of malignancies.
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- Combined with severe mental disorders and other conditions and unable to cooperate with follow-up.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Exposed group 1 Inebilizumab Intravenous methylprednisolone (IVMP) plus Inebilizumab Exposed group 2 Rituximab(RTX) IVMP plus Rituximab (RTX)
- Primary Outcome Measures
Name Time Method Change in Expanded Disability Status Scale Score (EDSS) from baseline. 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 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) 12 months Number of new, and/or enlarging T2-hyperintense lesions detected by Magnetic Resonance Imaging (MRI) at the last visit.
- Secondary Outcome Measures
Name Time Method Change in Expanded Disability Status Scale (EDSS) score from baseline 6 months Change in Expanded Disability Status Scale (EDSS) score from baseline at month 6 (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Change in modified Rankin score (mRS) from baseline 12 months Change in modified Rankin score (mRS) from baseline at month 12(mRS: Minimum Score 0, Maximum score 6, higher scores mean a worse outcome).
Change in serum glial fibrillary acidic protein antibody (GFAP-Ab) levels from baseline. 12 months Change in serum GFAP-Ab levels from baseline at the last visit
Change in serum Neurofilament light chain protein (NfL) levels from baseline. 12 months Change in serum NfL levels from baseline at the last visit.
Change in Visual Acuity (VA) from baseline 12 months Change in Visual Acuity (VA) at month 12.
Percentage of Participants with Disability Improvement 12 months Disability improvement is defined as a reduction in EDSS score of: A) \>=1.0 from the baseline EDSS score when the baseline score was \<=5.5 B) \>= 0.5 when the baseline EDSS score \> 5.5(EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
Change in Timed 25 Foot Walk Test from baseline 12 months Change in time taken to complete the timed 25foot walk test from baseline
Adverse reactions during treatment and follow-up 12 months Percentage of Participants with Disability Worsening 12 months A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.
Annual relapse rate (ARR) before and after Inebilizumab/Rituximab 12 months ARR will be measured in the baseline (according to patients' history before inebilizumab/rituximab) and after 12 months of intervention.
Change in aquaporin 4 antibody (AQP4-Ab) titers from baseline. 12 months Change in AQP4-ab titers from baseline at the last visit.
Changes in The Five Level of EuroQol Five Dimensions Questionnaire (EQ-5D-5L) scores from baseline 12 months Changes in EQ-5D scores from baseline at month 12(EQ-5D-5L: Minimum Score 5, Maximum score 25, lower scores mean a better quality of life).
Number of NMOSD attacked related rescue treatment. 12 months Change in retinal nerve fiber layer (RNFL) loss from baseline 12 months Change in retinal nerve fiber layer (RNFL) loss measured by optical coherence tomography (OCT) from baseline at month 12.