Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE
NCT ID: NCT05644210
Last Updated: 2022-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2022-10-01
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Telitacicept
160mg once a week for 24 weeks
Rituximab
Patients received 200mg of rituximab intravenously at week 0 and week 2.
Aspirin
50-100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response
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
Hydroxychloroquine
200mg, po, twice per day (Bid) prescribed，if tolerated by the patient， the dose should remain constant during the observation period
Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
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
Rituximab
Patients received 200mg of rituximab intravenously at week 0 and week 2.
Aspirin
50-100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response
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
Hydroxychloroquine
200mg, po, twice per day (Bid) prescribed，if tolerated by the patient， the dose should remain constant during the observation period
Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Interventions
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Telitacicept
160mg once a week for 24 weeks
Rituximab
Patients received 200mg of rituximab intravenously at week 0 and week 2.
Aspirin
50-100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response
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
Hydroxychloroquine
200mg, po, twice per day (Bid) prescribed，if tolerated by the patient， the dose should remain constant during the observation period
Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2.Patients who meet 1997 or 2019 SLE classification criteria ;
3.Positive LA /ACL/ aβ2GPI ,on two or more occasions, at least 12 weeks apart;
4.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;
5.Maintain a stable base treatment regimen for at least 4 weeks before screening; Basic treatment includes anticoagulants/antiplatelet agents, glucocorticoids, and hydroxychloroquine;
6.No response, intolerance or dependence on glucocorticoids and immunosuppressants;
7.Patients who had previously used beliumab or Telitacicept could be enrolled in the study after 12 weeks of discontinuation;
8.Age ≥18 years;
9.Signed Informed consent.
Exclusion Criteria
2.Severe cardiovascular diseases, kidney, liver and other important organ injuries, serious blood and endocrine system lesions (aplastic anemia, hyperthyroidism crisis, etc.) were excluded; A history of active malignancy (within 5 years) was excluded and chemoradiotherapy was performed; Patients with organ or bone marrow transplantation in the past year were excluded. Exclusion of mentally ill persons;
3.A history of allergy to the relevant test drug;
4.Patients had recently received a live vaccine or planned to use any live vaccine during the study;
5.Ongoing pregnancy;
6.Patients who were participants in clinical trials of other immunosuppressive agents/biologics within 24 weeks;
7.Other conditions that the investigator considers would make the candidate unsuitable for the study;
18 Years
65 Years
ALL
No
Sponsors
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Qilu Hospital of Shandong University
OTHER
Responsible Party
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Qiang Shu
Principal Investigator
Principal Investigators
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Yang Xiaoyun, Dr.
Role: STUDY_DIRECTOR
Qilu Hospital of Shandong University
Locations
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Qilu Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoyun Yang
Role: primary
Other Identifiers
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Bioagents in APS QiluH
Identifier Type: -
Identifier Source: org_study_id