Exploring the Therapeutic Effect of Telitacicept on Lupus Erythematosus Complicated With Thrombocytopenia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial Aimed at Exploring the Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus Patients With Refractory Thrombocytopenia

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Telitacicept
* Drug: conventional therapy
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets the 2012 ACR revised standards and meets four or more diagnostic criteria for systemic lupus erythematosus; Refractory thrombocytopenia (defined as receiving at least one course of methylprednisolone pulse therapy or intravenous injection of high-dose immunoglobulin or high-dose glucocorticoid combined with two or more Immunosuppressive drug failed and did not respond to any single drug); SLEENA-SLEDAI score is greater than or equal to 8 points. If anti ds-DNA antibody is positive and/or low complement, SLEENA-SLEDAI score is greater than or equal to 6 points, or PLT count is<10 * 10 ^ 9/L or<30 * 10 ^ 9/L with bleeding tendency; Age greater than or equal to 18 years old and less than or equal to 65 years old; Have a stable SLE treatment plan, and participants should receive standard treatment for at least 30 days before randomization; 6. Positive Antinuclear antibody or anti ds DNA antibody; 7. Sign informed documents. Exclusion criteria: Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria: Patients who are allergic to tamoxifen; Patients with severe active infection, history of tuberculosis, malignant tumor, HIV, hepatitis B, hepatitis C, important organs or hematopoietic stem cells/cells/bone marrow transplantation or kidney transplantation; Patients with severe active central nervous system lupus and severe active lupus nephritis Patients with diseases of liver, kidney, heart and other important organs, blood and Endocrine system; Pregnant and lactating women; Have a pregnancy preparation plan in the past year; Those who have merged with other autoimmune diseases; Incomplete case data and missing persons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>conventional treatment plus Telitacicept 160 mg sc per week | Drug: Telitacicept<br>* 160mg once a week for 48 weeks<br>* Other names: RC18;Drug: conventional therapy<br>* Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.<br>|
| Placebo Comparator: Control group<br>Placebo plus conventional treatment | Drug: conventional therapy<br>* Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.<br>Drug: Placebo<br>* Used once a week in combination with standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lupus erythematosus, Telitacicept, thrombocytopenia