This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and 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;
Antiphospholipid syndrome (APS);
Positive for LAC on two or more occasions greater than 12 weeks apart within the previous 18 months. If a candidate for the study is newly diagnosed (<12 weeks) with APS, meets clinical criteria for APS and has one positive LAC confirmed by review of the medical record, she may be consented and screened. At baseline, LAC will be measured at the study core lab and she will be enrolled if it is found to be positive. The LAC measurement will be repeated 12 weeks after the initial determination and, if positive, she will remain in the study.
Age 18-40 (+364 days) years of age and able to give informed consent
Hypertension (BP >140/90) present at screening;
Multifetal gestation;
Type 1 or Type 2 diabetes antedating pregnancy;
SLE patients requiring prednisone >10 mg/day;
David Ware Branch
Lead sponsor
University of Utah
Sponsor institution
Hospital for Special Surgery, New York
Collaborator
University of Toronto
Collaborator
NYU Langone Health
Collaborator