A Randomized Controlled Trial Aimed at Exploring the Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus Patients With Refractory Thrombocytopenia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 主要终点
- The remission rate of SLE response index at month 12 of treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus and refractory thrombocytopenia
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Positive Antinuclear antibody or anti ds DNA antibody;
- •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.
排除标准
- 未提供
研究组 & 干预措施
Treatment group
conventional treatment plus Telitacicept 160 mg sc per week
干预措施: Telitacicept (Drug)
Treatment group
conventional treatment plus Telitacicept 160 mg sc per week
干预措施: conventional therapy (Drug)
Control group
Placebo plus conventional treatment
干预措施: conventional therapy (Drug)
Control group
Placebo plus conventional treatment
干预措施: Placebo (Drug)
结局指标
主要结局
The remission rate of SLE response index at month 12 of treatment
时间窗: months 12
Use SRI-4 to represent the response index, with a higher response rate indicating better drug efficacy
Improvement in platelet count
时间窗: months 12
Platelet count at month of treatment，Increased platelet count indicates improvement in disease
次要结局
- Percentage of patients with a decrease of ≥ 4 points in the SELENA-SLEDAI score from baseline at months 6 and 12(months 6 and 12)
- Hormone reduction(month 12)
- B lymphocyte count(month 12)
研究者
Guanmin Gao
chief physician
The First Affiliated Hospital of Zhengzhou University