Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders

NCT ID: NCT06068829

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2025-06-30

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.

Conditions

Neuromyelitis Optica Spectrum Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Exposed group 1

Intravenous methylprednisolone (IVMP) plus Inebilizumab

Inebilizumab

Intervention Type: DRUG

Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inebilizumab was given after IVMP.

Exposed group 2

IVMP plus Rituximab (RTX)

Rituximab(RTX)

Intervention Type: DRUG

RTX: 500mg IV on Day 1 and Day15. The first dose of RTX was given after IVMP.

Interventions

Inebilizumab

Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inebilizumab was given after IVMP.

Intervention Type: DRUG

Rituximab(RTX)

RTX: 500mg IV on Day 1 and Day15. The first dose of RTX was given after IVMP.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Feng Jinzhou

OTHER

Sponsor Role: lead

Responsible Party

Feng Jinzhou

Ph.D

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jinzhou Feng, Ph.D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chongqing Medical University

Central Contacts

Jinzhou Feng, Ph.D

Role: CONTACT

203756@cqmu.edu.cn

023-89012487

Other Identifiers

IRNMO-001

Identifier Type: -

Identifier Source: org_study_id