The purpose of this study is to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus and refractory thrombocytopenia
This study is a single center, randomized, controlled trial to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus complicated with refractory thrombocytopenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
160mg once a week for 48 weeks
Steroid(≤1mg/kg/d) with or without proper immunosuppressants:CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
Used once a week in combination with standard treatment
The remission rate of SLE response index at month 12 of treatment
Use SRI-4 to represent the response index, with a higher response rate indicating better drug efficacy
Time frame: months 12
Improvement in platelet count
Platelet count at month of treatment,Increased platelet count indicates improvement in disease
Time frame: months 12
Percentage of patients with a decrease of ≥ 4 points in the SELENA-SLEDAI score from baseline at months 6 and 12
A decrease of ≥ 4 points from baseline in the SELENA-SLEDAI score indicates a good drug response effect
Time frame: months 6 and 12
Hormone reduction
Changes in patient hormone dose from baseline at month 12,reduced hormone dosage indicates improvement in disease
Time frame: month 12
B lymphocyte count
Changes in patient B lymphocyte count from baseline at month 12
Time frame: month 12
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