The Clinical Efficacy and Safety of Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE ，a Multicentre Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The proportion of patients who achieved response(complete response and partial response) in aPL profiles
研究概览
简要总结
The aim of this study was to observe the clinical efficacy and safety of rituximab (RTX) combination with telitacicept (TA) in patients of systemic lupus erythematosus secondary antiphospholipid syndrome (APS).
详细描述
In this multicenter, prospective, observational study, 80 patients with SLE Secondary APS patients were enrolled. RTX alone or its continuation with TA was observed for 24weeks，and extended for another 24 weeks. At week 12, the RTX group could be converted to the combination group. The primary end point was the response rate of total antiphospholipid antibody (aPL) at week 12. The secondary end points included the decline rate and value of aPL antibody, aGAPSS score, remission degree of specific clinical indicators, changes in SLE disease activity in SAPS group, and drug safety at week 12 and week 24.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •1.Patients who meet 2006 Sapporo classification criteria of APS or 2020 nonstandard APS performance；
- •2.Patients who meet 1997 or 2019 SLE classification criteria ;
- •3.Positive LA /ACL/ aβ2GPI ,on two or more occasions, at least 12 weeks apart;
- •4.with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, nephropathy, valve heart disease ,skin ulcer and arterial or deep vein thrombosis;
- •5.Maintain a stable base treatment regimen for at least 4 weeks before screening; Basic treatment includes anticoagulants/antiplatelet agents, glucocorticoids, and hydroxychloroquine;
- •6.No response, intolerance or dependence on glucocorticoids and immunosuppressants;
- •7.Patients who had previously used beliumab or Telitacicept could be enrolled in the study after 12 weeks of discontinuation;
- •8.Age ≥18 years;
- •9.Signed Informed consent.
排除标准
- •1.Patients with other causes of thrombocytopenia, hemolytic anemia, valvular heart disease, kidney disease and skin ulcer symptoms were excluded, such as drugs, infections, blood system diseases, genetic metabolic diseases, etc;
- •2.Severe cardiovascular diseases, kidney, liver and other important organ injuries, serious blood and endocrine system lesions (aplastic anemia, hyperthyroidism crisis, etc.) were excluded; A history of active malignancy (within 5 years) was excluded and chemoradiotherapy was performed; Patients with organ or bone marrow transplantation in the past year were excluded. Exclusion of mentally ill persons;
- •3.A history of allergy to the relevant test drug;
- •4.Patients had recently received a live vaccine or planned to use any live vaccine during the study;
- •5.Ongoing pregnancy;
- •6.Patients who were participants in clinical trials of other immunosuppressive agents/biologics within 24 weeks;
- •7.Other conditions that the investigator considers would make the candidate unsuitable for the study;
研究组 & 干预措施
RTX+TA group
Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period：Telitacicept 160mg once a week for 24 weeks Basic treatment： Hydroxychloroquine、Prednisone、Warfarin、Aspirin
干预措施: Telitacicept (Drug)
RTX+TA group
Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period：Telitacicept 160mg once a week for 24 weeks Basic treatment： Hydroxychloroquine、Prednisone、Warfarin、Aspirin
干预措施: Rituximab (Drug)
RTX+TA group
Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period：Telitacicept 160mg once a week for 24 weeks Basic treatment： Hydroxychloroquine、Prednisone、Warfarin、Aspirin
干预措施: Aspirin (Drug)
RTX+TA group
Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period：Telitacicept 160mg once a week for 24 weeks Basic treatment： Hydroxychloroquine、Prednisone、Warfarin、Aspirin
干预措施: Warfarin (Drug)
RTX+TA group
Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period：Telitacicept 160mg once a week for 24 weeks Basic treatment： Hydroxychloroquine、Prednisone、Warfarin、Aspirin
干预措施: Hydroxychloroquine (Drug)
RTX+TA group
Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period：Telitacicept 160mg once a week for 24 weeks Basic treatment： Hydroxychloroquine、Prednisone、Warfarin、Aspirin
干预措施: Prednisone (Drug)
RTX group
Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period Basic treatment：Hydroxychloroquine、Prednisone、Warfarin、Aspirin
干预措施: Rituximab (Drug)
RTX group
Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period Basic treatment：Hydroxychloroquine、Prednisone、Warfarin、Aspirin
干预措施: Aspirin (Drug)
RTX group
Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period Basic treatment：Hydroxychloroquine、Prednisone、Warfarin、Aspirin
干预措施: Warfarin (Drug)
RTX group
Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period Basic treatment：Hydroxychloroquine、Prednisone、Warfarin、Aspirin
干预措施: Hydroxychloroquine (Drug)
RTX group
Screening stage：Patients received 200mg of rituximab intravenously at week 0 and week 2.
Follow-up period Basic treatment：Hydroxychloroquine、Prednisone、Warfarin、Aspirin
干预措施: Prednisone (Drug)
结局指标
主要结局
The proportion of patients who achieved response(complete response and partial response) in aPL profiles
时间窗: Week 12
For the lupus anticoagulant (LAC) test, we defined complete response (CR) as a negative test result and no response(NR) as a positive test result； For the anticardiolipin antibody (aCL)/anti-β2 glycoprotein I (anti-β2GPI)enzyme-linked immunosorbent assay,CR was defined as a titer of\<the 95th percentile, partial response (PR) was defined as a titer of 95th -99th , and NR was defined as a titer of \>the 99th percentile.
次要结局
- The change of aPL titer(week 12 , 24,48)
- The change of Damage Index for Antiphospholipid Syndrome (DIAPS)(Before the screening and week 12,24,48)
- The change of Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2k) Score(Before the screening,baseline and week 12,24,48)
- The change of clinical efficacy in subgroups with different symptoms(Before the screening,baseline and week 12,24,48)
- The change of aGAPSS score(Before the screening,baseline and week 12,24,48)
- The changes of the positive number of 7 aPL indicators(week 12, 24,48)
- Glucocorticoid (GC) dose and reduction rate(Before the screening,baseline and week 4,12,24,48)
- The proportion of patients who achieved response(complete response and partial response) in aPL profiles(Week 24,48)
- The change of Physician Global Assessment (PGA) score .(Before the screening,baseline and week 12,24,48)
- The percentage of patients with Lupus Low Disease Activity State (LLDAS)(Before the screening,baseline and week 12,24,48)
研究者
Qiang Shu
Principal Investigator
Qilu Hospital of Shandong University