NCT05644210

Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Antiphospholipid Syndrome

Interventions

Type	Name	Description
DRUG	Telitacicept	160mg once a week for 24 weeks
DRUG	Rituximab	Patients received 200mg of rituximab intravenously at week 0 and week 2.
DRUG	Aspirin	50-100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response
DRUG	Warfarin	Warfarin should be used in patients with arterial thrombosis, and rivaroxaban should be replaced if the patient cannot reach the standard or cannot tolerate it
DRUG	Hydroxychloroquine	200mg, po, twice per day (Bid) prescribed，if tolerated by the patient， the dose should remain constant during the observation period
DRUG	Prednisone	5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2022-12-09
• Last updated: 2022-12-09

Locations

1 site across 1 country: China