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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 1.Patients who meet 2006 Sapporo classification criteria of APS or 2020 nonstandard APS performance;

⁃ 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.

Locations
Other Locations
China
Qilu Hospital
RECRUITING
Jinan
Contact Information
Primary
Shu Qiang, Dr.
shuqiang@sdu.edu.cn
0086-0531-82169654
Backup
Zhang Xiaoyu
1146978430@qq.com
0086-0531-82169654
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 80
Treatments
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
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
Sponsors
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov