Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Nov 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a new treatment for patients with Antiphospholipid Syndrome (APS) related to Systemic Lupus Erythematosus (SLE). The treatment combines two medications: telitacicept and rituximab. The goal is to find out if this combination can help people who have APS, which can cause problems like blood clots and other serious health issues.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of APS and SLE, along with specific blood test results. They should also have experienced at least one additional health problem related to APS, such as low platelet counts or kidney issues. Participants will need to maintain a stable medication routine for at least a month before joining the study. It's important to note that some individuals, such as those with severe organ damage or certain allergies, will not be eligible. If you choose to participate, you can expect regular check-ups and monitoring to ensure your safety throughout the trial.

Gender

ALL

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;

Trial Officials