Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965284
Status:
RECRUITING
Last Update Posted:
2023-07-28
First Post:
2023-07-20
Brief Title:
Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis TTCAZAREM
Sponsor:
Chinese SLE Treatment And Research Group
Organization:
Chinese SLE Treatment And Research Group
Study Overview
Official Title:
A Prospective Open-label Controlled Single Center Clinical Study of the Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis
Status:
RECRUITING
Status Verified Date:
2023-07
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:
This study is a prospective open-labelled randomized controlled single-center clinical trial The aim of this study is to compare the remission rate of patients treated with Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance treatment of AAV
Detailed Description:
Background The basic theme of AAV is relapse and remission The maintenance therapy of AAV aimed to reduce or prevent relapse is very challenge Although many medications have been used for the maintenance of AAV Telitacicept a BAFFAPRIL dual-target-inhibitor which has been proved to be effect in treatment of SLE has not been studied yet One study tested the efficacy of Belimumab in the maintenance therapy for AAV When taken Rituximab as remission-induction treatment no relapse was observed However the sample size of this study is small and the Belimumab as a BAFF inhibitor was not been proved to have effect on APRIL
Many experiences have been accumulated about the efficacy and safety of Telitacicept in Chinese patients with rheumatic diseases But there is no study to show its effectiveness in the reduction of the relapse of AAV in China In this study we add Telitacicept to azathioprine in maintain treatment in AAV patients who receive Rituximab as remission-induction treatment to compare the relapse rates of Telitacicept combining azathioprine and azathioprine alone in maintenance therapy of AAV
Objectives To compare the relapse rates of Telitacicept combining azathioprine and azathioprine alone in maintenance treatment of AAV
Study Design This is a prospective randomized open-label control pilot study
Many experiences have been accumulated about the efficacy and safety of Telitacicept in Chinese patients with rheumatic diseases But there is no study to show its effectiveness in the reduction of the relapse of AAV in China In this study we add Telitacicept to azathioprine in maintain treatment in AAV patients who receive Rituximab as remission-induction treatment to compare the relapse rates of Telitacicept combining azathioprine and azathioprine alone in maintenance therapy of AAV
Objectives To compare the relapse rates of Telitacicept combining azathioprine and azathioprine alone in maintenance treatment of AAV
Study Design This is a prospective randomized open-label control pilot study
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