Telitacicept in Primary APS Patients

Phase 2TerminatedNCT05078710

Peking Union Medical College Hospital20 enrolled

Overview

This is a single-arm pilot study in Peking Union Medical College Hospital. Telitacicept will be added on traditional antithrombotic and immunosuppressive treatment in primary antiphospholipid syndrome (APS) patients with three positive antiphospholipid antibodies (aPL) and at least one extra-criteria manifestations, including thrombocytopenia, autoimmune hemolytic anemia, aPL associated nephropathy, heart valvular disease, non-stroke neurological manifestations. This study aims to evaluate the efficacy of Telitacicept in preventing thrombosis and improving extra-criteria manifestations on high-risk APS patients.

The study started on July 2021 and will last 1.5 years. Primary APS patients with three positive aPL and extra-criteria manifestations with be enrolled. This is a single-arm pilot study. Telitacicept 160mg once a week for 24 weeks will be added on traditional antithrombotic and immunosuppressive treatment. Patients will be followed on week 12 and week 24. The primary endpoint is new thrombotic event. The secondary endpoints are improvement of extra-criteria manifestations, and titer change of aPL.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anti Phospholipid Syndrome

Interventions

TelitaciceptDRUG

160mg once a week for 24 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * meet 2006 Sapporo classification criteria of APS; * diagnosis of primary APS, exclude other etiologies of thrombosis; * with three aPL medium-to-high titer positivity, namely lupus anticoagulant, anti cardiolipin antibody, and anti-β2 glycoprotein antibody; * with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valve heart disease and neurological manifestations. Exclusion Criteria: * overlap with other connective tissue diseases, such as systemic lupus erythematosus; * during pregnancy; * can not follow-up.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

new thrombotic event

any new thrombotic event during Telitacicept treatment

Time frame: 24 weeks

Secondary Outcomes

improvement of thrombocytopenia during Telitacicept treatment

elevated platelet counts

Time frame: 24 weeks

improvement of hemolytic anemia during Telitacicept treatment

elevated hemoglobin

Time frame: 24 weeks

improvement of aPL nephropathy during Telitacicept treatment

decrease of proteinuria or creatinine

Time frame: 24 weeks

improvement of valve heart disease during Telitacicept treatment

decrease of valve thickness or vegetation by echocardiogram

Time frame: 24 weeks

improvement of neurological manifestations during Telitacicept treatment

MRI improvement

Time frame: 24 weeks

decrease of aPL titer during Telitacicept treatment

titer change of lupus anticoagulant, anticardiolipin antibody and anti-β2 glycoprotein-I antibody

Time frame: 24 weeks

Data from ClinicalTrials.gov

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