Status:
UNKNOWN
Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders
Lead Sponsor:
Feng Jinzhou
Conditions:
Neuromyelitis Optica Spectrum Disorders
Eligibility:
All Genders
18+ years
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-...
Eligibility Criteria
Inclusion
- 1\. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
- 2\. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the acute phase.
- 3\. Patients have given their written informed consent.
Exclusion
- 1\. Lactating and pregnant females.
- 2\. Participate in other interventional studies within 30 days or within 5 half-lives of the investigational agent before received inebilizumab and rituximab (RTX).
- 3\. Receipt of any experimental B-cell depleting agent within 6 months prior inebilizumab and RTX, and B-cells below the lower limit of normal
- 4\. Known history of a severe allergy or reaction to any component of the investigational product formulation.
- 5\. 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).
- 6\. History of alcohol, drug, or chemical abuse, or a recent history of such abuse \< 1 year prior to treatment.
- 7\. History of malignancies.
- 8\. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up.
Key Trial Info
Start Date :
October 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06068829
Start Date
October 20 2023
End Date
June 30 2025
Last Update
October 5 2023
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