This study is an Investigator initiated, randomized, multicenter, double-blind, placebo-control study. The aim of this study is to evaluate the safety and efficiency of Sirolimus for primaty antiphospholipid syndrome patients at week 24 and week 48.
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Male or Female
aged 18-70 at the time of screening visit
Met 2006 Sapporo classification criteria of APS or 2023 ACR/EULAR classification criteria of APS
history of serious adverse events or contraindication to Sirolimus
Catastrophic APS within 90 days
Acute thrombosis within 30 days
≥4/11 American College of Rheumatology Classification Criteria for SLE or other systemic autoimmune diseases
Parallel
Sirolimus
DrugSubjects will receive Sirolimus 1.5mg/d for 48 weeks in addition to their ongoing APS treatment regimen
Placebo
DrugSubjects will receive Placebo 1.5mg/d for first 24 weeks and Sirolimus 1.5mg/d for next 24 weeks in addition to their ongoing APS treatment regimen
Complete response(CR) rate at week 24
CR will be defined as follows: 1.No thrombosis events; 2.PLT ≥100 and with nobleeding; 3. No persistent autoimmnune haemolytic anaemia; 4. No skin ulcer; 5.No renal thrombotic microangiopathy; 5.Normal cognitive function (MoCA score ≥26）.
Partial response (PR) rate at week 24
PR will be defined as one of follows: 1.superficial thrombotic events;2. PLT ≥30 or increased at least 2 times of baseline and with no bleeding;3.haemoglobulin concentration normal or increased 20g/L compared to baseline; 4.50% improvement; 5. a serum creatinine level 15% abov baseline, RBCs per high-power field 50% above baseline with no casts, 50% improvement in the urinary prt:cr; 6. milde cognitive diysfunction (MoCA 9\~25).
Complete response(CR) rate at week 48
CR will be defined as follows: 1.No thrombosis events; 2.PLT ≥100 and with nobleeding; 3. No persistent autoimmnune haemolytic anaemia; 4. No skin ulcer; 5.No renal thrombotic microangiopathy; 5.Normal cognitive function (MoCA score ≥26）.
Partial response (PR) rate at week 48
PR will be defined as one of follows: 1.superficial thrombotic events;2. PLT ≥30 or increased at least 2 times of baseline and with no bleeding;3.haemoglobulin concentration normal or increased 20g/L compared to baseline; 4.50% improvement; 5. a serum creatinine level 15% abov baseline, RBCs per high-power field 50% above baseline with no casts, 50% improvement in the urinary prt:cr; 6. milde cognitive diysfunction (MoCA 9\~25).
Rate of Participants with adverse effects and serious adverse effects during treatment
Adverse effects include fever, rash, abnormal liver function, rate of new-onset infections and any abnormal measures after recivede study drug.
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This trial is not recruiting at the moment. You can still explore other options:
