Institutional Review Board, Hospital for Special Surgery
December 03, 2020
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Avi Mikhaylov
Margaret Minett
Hayley Slosberg
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.
Inclusion Criteria:
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.
Exclusion Criteria:
Known contraindications or relative contraindications to certolizumab:
Project Coordinator
Marta M. Guerra, M.S.
212.774.7361
guerram@hss.edu