Anti Phospholipid Syndrome
Conditions
Keywords
anti phospholipid syndrome
Brief summary
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.
Detailed description
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.
Interventions
DRUGTelitacicept
160mg once a week for 24 weeks
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| new thrombotic event | 24 weeks | any new thrombotic event during Telitacicept treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| improvement of hemolytic anemia during Telitacicept treatment | 24 weeks | elevated hemoglobin |
| improvement of aPL nephropathy during Telitacicept treatment | 24 weeks | decrease of proteinuria or creatinine |
| improvement of thrombocytopenia during Telitacicept treatment | 24 weeks | elevated platelet counts |
| improvement of neurological manifestations during Telitacicept treatment | 24 weeks | MRI improvement |
| decrease of aPL titer during Telitacicept treatment | 24 weeks | titer change of lupus anticoagulant, anticardiolipin antibody and anti-β2 glycoprotein-I antibody |
| improvement of valve heart disease during Telitacicept treatment | 24 weeks | decrease of valve thickness or vegetation by echocardiogram |
Countries
China
Outcome results
None listed