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Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE

NCT05644210 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2022-12-09

No results posted yet for this study

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).

Conditions

  • Antiphospholipid Syndrome

Interventions

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

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Yang Xiaoyun, Dr. · Qilu Hospital of Shandong University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05644210 on ClinicalTrials.gov