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Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE

China80 participantsStarted 2022-10-01

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓.Patients who meet 1997 or 2019 SLE classification criteria ;
✓.Positive LA /ACL/ aβ2GPI ,on two or more occasions, at least 12 weeks apart;
✓.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;
✓.Maintain a stable base treatment regimen for at least 4 weeks before screening; Basic treatment includes anticoagulants/antiplatelet agents, glucocorticoids, and hydroxychloroquine;
✓.No response, intolerance or dependence on glucocorticoids and immunosuppressants;
✓.Patients who had previously used beliumab or Telitacicept could be enrolled in the study after 12 weeks of discontinuation;
✓.Age ≥18 years;
✓.Signed Informed consent.

Exclusion criteria

✕.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;
✕.A history of allergy to the relevant test drug;
✕.Patients had recently received a live vaccine or planned to use any live vaccine during the study;
✕.Ongoing pregnancy;
✕.Patients who were participants in clinical trials of other immunosuppressive agents/biologics within 24 weeks;
✕.Other conditions that the investigator considers would make the candidate unsuitable for the study;

What they're measuring

The proportion of patients who achieved response(complete response and partial response) in aPL profiles

Timeframe: Week 12

Trial details

NCT IDNCT05644210

SponsorQilu Hospital of Shandong University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-30

Contact for this trial

Shu Qiang, Dr.

0086-0531-82169654 shuqiang@sdu.edu.cn

View on ClinicalTrials.gov More Antiphospholipid Syndrome trials