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Clinical Trial 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).


Clinical Trial Description

In this multicenter, prospective, observational study, 80 patients with SLE Secondary APS patients were enrolled. RTX alone or its continuation with TA was observed for 24weeks,and extended for another 24 weeks. At week 12, the RTX group could be converted to the combination group. The primary end point was the response rate of total antiphospholipid antibody (aPL) at week 12. The secondary end points included the decline rate and value of aPL antibody, aGAPSS score, remission degree of specific clinical indicators, changes in SLE disease activity in SAPS group, and drug safety at week 12 and week 24. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05644210
Study type Observational
Source Qilu Hospital of Shandong University
Contact Shu Qiang, Dr.
Phone 0086-0531-82169654
Email shuqiang@sdu.edu.cn
Status Recruiting
Phase
Start date October 1, 2022
Completion date December 30, 2025

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