A Pilot Study of Telitacicept Treatment in Primary APS Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- new thrombotic event
研究概览
简要总结
This is a single-arm pilot study in Peking Union Medical College Hospital. Telitacicept will be added on traditional antithrombotic and immunosuppressive treatment in primary antiphospholipid syndrome (APS) patients with three positive antiphospholipid antibodies (aPL) and at least one extra-criteria manifestations, including thrombocytopenia, autoimmune hemolytic anemia, aPL associated nephropathy, heart valvular disease, non-stroke neurological manifestations. This study aims to evaluate the efficacy of Telitacicept in preventing thrombosis and improving extra-criteria manifestations on high-risk APS patients.
详细描述
The study started on July 2021 and will last 1.5 years. Primary APS patients with three positive aPL and extra-criteria manifestations with be enrolled. This is a single-arm pilot study. Telitacicept 160mg once a week for 24 weeks will be added on traditional antithrombotic and immunosuppressive treatment. Patients will be followed on week 12 and week 24. The primary endpoint is new thrombotic event. The secondary endpoints are improvement of extra-criteria manifestations, and titer change of aPL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •meet 2006 Sapporo classification criteria of APS;
- •diagnosis of primary APS, exclude other etiologies of thrombosis;
- •with three aPL medium-to-high titer positivity, namely lupus anticoagulant, anti cardiolipin antibody, and anti-β2 glycoprotein antibody;
- •with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valve heart disease and neurological manifestations.
排除标准
- •overlap with other connective tissue diseases, such as systemic lupus erythematosus;
- •during pregnancy;
- •can not follow-up.
研究组 & 干预措施
Telitacicept arm
Telitacicept 160mg once a week for 24 week as an add-on treatment regimen.
干预措施: Telitacicept (Drug)
结局指标
主要结局
new thrombotic event
时间窗: 24 weeks
any new thrombotic event during Telitacicept treatment
次要结局
- improvement of neurological manifestations during Telitacicept treatment(24 weeks)
- improvement of thrombocytopenia during Telitacicept treatment(24 weeks)
- improvement of valve heart disease during Telitacicept treatment(24 weeks)
- improvement of hemolytic anemia during Telitacicept treatment(24 weeks)
- decrease of aPL titer during Telitacicept treatment(24 weeks)
- improvement of aPL nephropathy during Telitacicept treatment(24 weeks)