A Multicentric, Retrospective, Real-Word Study to Evaluate the Efficacy and Safety of Inebilizumab Compare With Rituximab in Neuromyelitis Optica Spectrum Disorders

IRNMO-001

To compare the safety and efficacy of Inebilizumab and Rituximab in neuromyelitis optica spectrum disorders (NMOSD) patients.

2023-10-20

2024-06-30

2025-06-30

Not yet recruiting

80

Inclusion Criteria: * 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 Criteria: * 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.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples are collected before the treatment and at the last follow-up.'}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2023-10-05