Observing the effects of telitacicept and rituximab in patients with antiphospholipid syndrome related to lupus

The Clinical Efficacy and Safety of Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE ，a Multicentre Observational Study

This study is testing if combining two medications, telitacicept and rituximab, can help people with lupus related to antiphospholipid syndrome feel better and stay safe.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Drugs / interventions: beliumab, rituximab
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT05644210 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the clinical efficacy and safety of combining rituximab with telitacicept in patients suffering from systemic lupus erythematosus secondary to antiphospholipid syndrome. A total of 80 patients will be enrolled and monitored over a 24-week period, with the possibility of extending the observation for another 24 weeks. The primary endpoint focuses on the response rate of antiphospholipid antibodies at week 12, while secondary endpoints include various clinical indicators and safety assessments. The study will also allow for the conversion of patients from rituximab alone to the combination therapy at week 12 if necessary.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who meet specific classification criteria for antiphospholipid syndrome and systemic lupus erythematosus.

Not a fit: Patients with other causes of thrombocytopenia or hemolytic anemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with antiphospholipid syndrome secondary to systemic lupus erythematosus.

How similar studies have performed: While this approach is novel in its specific combination, similar studies have shown promise in treating related conditions with rituximab.

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;

Where this trial is running

Jinan, Shandong

• Qilu Hospital — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Shu Qiang, Dr.

Conditions Antiphospholipid Syndrome; Telitacicept; Rituximab