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;
Single group
Certolizumab Pegol
DrugCertolizumab \[400 mg (given as two subcutaneous injections of 200mg) initially and 2 and 4 weeks later, followed by 200 mg every other week thereafter\] The 1st dose of certolizumab will be administered by 8 weeks and 6 days gestation and discontinued at 27 weeks 6 days. The regimen of heparin and low dose aspirin is a standard of care treatment for this patient population and is not considered part of the research intervention.
Fetal death and/or preterm delivery (<34 weeks) due to PE or PI in women with APS and LAC
Either of the following will constitute a primary outcome: 1. Fetal death (\>10 wks gestation) 2. Severe preeclampsia or placental insufficiency requiring delivery prior to 34 weeks gestation.
Additional adverse outcomes or pertinent concerns, possibly related to study intervention
Any one of the following is considered a secondary outcome: 1. Neonatal death due to complications of prematurity because of preterm delivery for PE or PI 2. Preterm labor or preterm rupture of membranes resulting in delivery prior to 36 weeks gestation 3. PE or PI not requiring delivery prior to 34 weeks gestation 4. Gestational age at delivery 5. Maternal thrombosis 6. Small-for-gestational age birthweight (\<10th percentile) 7. Known adverse reactions to certolizumab.
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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
