Ignite Creation Date:
2024-05-06 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03350633
Status:
COMPLETED
Last Update Posted:
2019-10-24
First Post:
2017-11-10
Brief Title:
Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders
Sponsor:
Tianjin Medical University General Hospital
Organization:
Tianjin Medical University General Hospital
Study Overview
Official Title:
Safety and Efficacy of Tocilizumab Versus Azathioprine in Neuromyelitis Optica Spectrum Disorders a Randomized Controlled Open-label Phase 2 Trial
Status:
COMPLETED
Status Verified Date:
2019-10
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:
TANGO
Brief Summary:
In neuromyelitis optica spectrum disorder NMOSDinterleukin-6 IL-6 may play an important role in facilitating plasma cells to produce pathological aquaporin 4 AQP4 autoantibody Inhibition of IL-6 signaling pathway by Tocilizumab ACTEMRA a humanized monoclonal antibody may have shown beneficial clinical effects in a few patients with NMOSD
Larger scale clincial trials may be needed to observe its efficacy and safety Here by choosing azathioprine one of the most frequently used medication in case of relapses the investigators compare the safety and efficacy of tocilizumab in preventing NMOSD attacks
Larger scale clincial trials may be needed to observe its efficacy and safety Here by choosing azathioprine one of the most frequently used medication in case of relapses the investigators compare the safety and efficacy of tocilizumab in preventing NMOSD attacks
Detailed Description:
The investigators primarily aim to observe the time to first relapse from initiation of tocilizumab or azathioprine treatment The proportion of participants who experience relapse-free in one year follow-up will be compared
The secondary outcomes are to determine The safety profile of tocilizumab and azathioprine in participants with NMO and whether tocilizumab improves visual function Expanded Disability Status Scale EDSS et al
The secondary outcomes are to determine The safety profile of tocilizumab and azathioprine in participants with NMO and whether tocilizumab improves visual function Expanded Disability Status Scale EDSS et al
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