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NCT05644210
Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE
Conditions: Antiphospholipid Syndrome
Sex: All
Ages: 18 Years – 65 Years
Enrollment: 80
Sponsor: Qilu Hospital of Shandong University
Location: China
Summary
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).
Eligibility Criteria
Inclusion Criteria: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.Exclusion Criteria: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;
Source: ClinicalTrials.gov (NCT05644210). StuddyBuddy aggregates publicly available trial information.