This study is to evaluate the efficacy and safety of a novel chemical synthetic agent iguratimod as treatment of refractory lupus nephritis. All subjects should have at least one failed immunosuppressive treatment and suffer active nephritis at the screening stage. The study period is 52 week. All the subject will receive therapy of iguratimod combined with steroids.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Iguratimod 25mg twice a day, oral administrated.
RenJi Hospital
Shanghai, Shanghai Municipality, China
Renal remission rate
Time frame: Week 52
Renal remission rate
Time frame: Week 24
Renal flare rate
Time frame: Week 52
Number of participants with treatment-related adverse events
Adverse events are assessed by CTCAE v4.0
Time frame: Week 52
Systemic Lupus Erythematosus Disease Activity Index inSafety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI)
Time frame: Week 52
British Isles Lupus Activity Group (BILAG) score
Time frame: Week 52
PGA
Patient general assessment
Time frame: Week 52
Quality of life
Measured by HAQ
Time frame: Week 52
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