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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | conventional treatment plus Telitacicept 160 mg sc per week |
|
| Control group | Placebo Comparator | Placebo plus conventional treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telitacicept | Drug | 160mg once a week for 48 weeks |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | months 12 |
| Improvement in platelet count | Platelet count at month of treatment,Increased platelet count indicates improvement in disease | months 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | months 6 and 12 |
| Hormone reduction |
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Inclusion Criteria:
7. Sign informed documents.
Exclusion criteria:
Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gao Guanmin | Contact | 13613716851 | Guanmingao@zzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gao Guanmin | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000722462 | telitacicept |
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| conventional therapy | Drug | Steroid(≤1mg/kg/d) with or without proper immunosuppressants:CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc. |
|
| Placebo | Drug | Used once a week in combination with standard treatment |
|
Changes in patient hormone dose from baseline at month 12,reduced hormone dosage indicates improvement in disease |
| month 12 |
| B lymphocyte count | Changes in patient B lymphocyte count from baseline at month 12 | month 12 |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |