Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394063
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-28
Brief Title:
Efficacy and Safety of Telitacicept for Prevention of Flares in SLE Patients
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Trial of Efficacy and Safety of Low-dose Telitacicept for Prevention of Flares in SLE Patients With Low Disease Activity
Status:
RECRUITING
Status Verified Date:
2024-07
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 randomized double-blind placebo-controlled single-center clinical trial The aim of this study is to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity
Detailed Description:
Background There are still two major problems in the treatment of SLE flare and long-term organ damage BLISS-52 showed there was some reduction of flare 80 vs 71 in belimumab but the difference was not significant Another study tested the efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe SLE in which analysis of atacicept 150 mg suggested benefit
Telitacicept a BAFFAPRIL dual-target-inhibitor which has been proved to be effective in treatment of SLE But there is no study to show its effectiveness for prevention of flares in SLE patients with low disease activity In this study we take telitacicept as maintain treatment in stable SLE patients to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity
Telitacicept a BAFFAPRIL dual-target-inhibitor which has been proved to be effective in treatment of SLE But there is no study to show its effectiveness for prevention of flares in SLE patients with low disease activity In this study we take telitacicept as maintain treatment in stable SLE patients to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity
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