Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06068829
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-05
First Post:
2023-09-29
Brief Title:
Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders
Sponsor:
Feng Jinzhou
Organization:
First Affiliated Hospital of Chongqing Medical University
Study Overview
Official Title:
A Multicentric Retrospective Real-Word Study to Evaluate the Efficacy and Safety of Inebilizumab Compare With Rituximab in Neuromyelitis Optica Spectrum Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ADCCcomplement-dependent cytotoxicity CDC promotes an immunoregulatory T-lymphocyte phenotype and activates neutrophilmacrophage 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
Rituximab RTX is a chimeric anti-CD20 monoclonal antibody that promotes B-lymphocyte depletion through antibody-dependent cellular cytotoxicity ADCCcomplement-dependent cytotoxicity CDC promotes an immunoregulatory T-lymphocyte phenotype and activates neutrophilmacrophage 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None