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.
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 BAFF/APRIL 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
176
Telitacicept 160 mg SC every other week
Placebo to Telitacicept
Ren Ji Hospital
Shanghai, China
RECRUITINGPercentage of patients with disease flares
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Time frame: 52 weeks
Percentage of patients with mild/moderate flares
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Time frame: 52 weeks
Percentage of patients with major flares
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Time frame: 52 weeks
Time to first disease flare
Time to first disease flare defined by modified SELENA-SLEDAI SLE flare index (SFI).
Time frame: 52 weeks
Prednisone dose at each visit
Compare the prednisone dose at each visit
Time frame: 52 weeks
PGA score at each visit
Compare the disease activity measured by PGA score at each visit
Time frame: 52 weeks
SELENA-SLEDAI score at each visit
Compare the disease activity measured by SELENA-SLEDAI score at each visit
Time frame: 52 weeks
Maintenance time of LLDAS/Remission
To record the maintenance time of LLDAS/Remission
Time frame: 52 weeks
Number of participants with adverse events as assessed by CTCAE v5.0
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The safety of telitacicept
Time frame: 52 weeks