Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE

Sponsor
Qilu Hospital of Shandong University
Study ID
NCT05644210
Status
Unknown

Conditions

  • Antiphospholipid Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept — DRUG
    160mg once a week for 24 weeks
  • Rituximab — DRUG
    Patients received 200mg of rituximab intravenously at week 0 and week 2.
  • Aspirin — DRUG
    50-100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response
  • Warfarin — DRUG
    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
  • Hydroxychloroquine — DRUG
    200mg, po, twice per day (Bid) prescribed，if tolerated by the patient， the dose should remain constant during the observation period
  • Prednisone — DRUG
    5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response

Study Details

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).

Key Dates

Start date
Oct 1, 2022
Status verified
Nov 2022
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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

Primary Outcome Measure

The proportion of patients who achieved response(complete response and partial response) in aPL profiles [ Time Frame: Week 12 ]

Central Contacts

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