A Phase 2 interventional study of Telitacicept and conventional therapy in Systemic Lupus Erythematosus, sponsored by Guanmin Gao. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Guanmin Gao · Phase 2, Interventional, and Treatment
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.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's planned enrollment of 64 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →This is the only study on the registry with Guanmin Gao as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria:
conventional treatment plus Telitacicept 160 mg sc per week
Drug: Telitacicept · Drug: conventional therapy
Placebo plus conventional treatment
Drug: conventional therapy · Drug: Placebo
160mg once a week for 48 weeks
Also known as: RC18
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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