IRB Number: 2017-0317
Institutional Review Board, Hospital for Special Surgery
December 03, 2020
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Jane E. Salmon, MD
Patients with antiphospholipid syndrome are at increased risk for pregnancy complications, and inflammation contributes to injury of the placenta. Studies in animal models have shown that blockade to TNF, a cytokine of inflammation, prevents pregnancy complications.
The objective of this trial is to evaluate whether adding certolizumab to standard treatment will decrease the frequency of severe pregnancy complications, such as preeclampsia, in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC).
All patients will receive certolizumab, a TNF blocking medication that does not cross the placenta, in addition to the heparin and aspirin prescribed by their physician. The medication will be injected subcutaneously by the participant every other week from eight weeks through 28 weeks of pregnancy.
Pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.
- Pregnant as defined by positive test for elevated ß-HCG and having a live, appropriate sized embryo by ultrasound, but <8 weeks gestation;
APS and positive for LAC on two or more occasions greater than 12 weeks apart within the previous 18 months and confirmed by review of medical records and core laboratory testing;
a: The diagnosis of APS and LAC will be confirmed by one of the Co-PIs for each case by a review of the medical records.
- Age 18-38 (+364 days) years of age and able to give informed consent
- Laboratory hematocrit >26% at time of screening.
Marta M. Guerra, M.S.