Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03062579
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2017-02-13
Brief Title:
A Longitudinal Study of ACTEMRA Tocilizumab as Monotherapy in Highly Active NMOSD
Sponsor:
Fu-Dong Shi
Organization:
Tianjin Medical University General Hospital
Study Overview
Official Title:
Single-center Open Label Trial of ACTEMRA Tocilizumab as Monotherapy in Highly Active Neuromyelitis Optica Spectrum Disorders NMOSD
Status:
COMPLETED
Status Verified Date:
2024-04
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:
Neuromyelitis Optica Spectrum Disorder NMOSD is a severe inflammatory disease of the central nervous system characterized by relapsing optic neuritis and longitudinal extensive transverse myelitis The specific autoantibody against aquaporin 4 AQP4-ab has been suggested to contribute to the pathogenesis of the disease Peripheral blood plasma cells are a major source of AQP4-ab Previous studies have observed increased IL-6 levels in serum and cerebrospinal fluid of patients with NMOSD particularly during relapses Exogenous interleukin IL-6 promotes the survival of plasma cells and their production of AQP4-ab in vitro And blockade of IL-6 receptor signaling by an anti-IL-6 receptor antibody reduces the survival of plasma cells in vitro Tocilizumab ACTEMRA a humanized monoclonal antibody against the IL-6 receptor has shown beneficial clinical effects in some patients with NMOSD when concomitant immunosuppressive medications were administered However the long-lasting biological effects of preceding immunotherapies such as rituximab might overlap with the subsequent tocilizumab therapy To reduce the side effects of concomitant treatments to large extent and verify the beneficial effects of tocilizumab we evaluate the safety and efficacy of tocilizumab as monotherapy in patients with NMOSD
Detailed Description:
The purpose of this study is to determine if the drug tocilizumab as monotherapy contributes to reduce the average relapsing rate ARR and improve neurological disability in NMOSD patients who still have experienced relapses when common immunosuppressive medications including rituximab had been used
The primary most important objectives of this study are to determine Whether bortezomib reduces relapse frequency in patients with relapsing NMO The number of attacks during the one year treatment period will be compared to the number of attacks that occurred prior to initiation of tocilizumab treatment
The secondary objectives are to determine
The safety profile of tocilizumab in patients with NMO and whether tocilizumab improves walking visual function and quality of life as measured by a variety of established disability scales
The primary most important objectives of this study are to determine Whether bortezomib reduces relapse frequency in patients with relapsing NMO The number of attacks during the one year treatment period will be compared to the number of attacks that occurred prior to initiation of tocilizumab treatment
The secondary objectives are to determine
The safety profile of tocilizumab in patients with NMO and whether tocilizumab improves walking visual function and quality of life as measured by a variety of established disability scales
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?:
False
Is an FDA AA801 Violation?:
None