Certolizumab for Pregnancy Complications Due to APS
Trial Summary
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does require you to continue with usual treatment, which includes a heparin agent and low-dose aspirin.
Is Certolizumab Pegol safe for use during pregnancy?
How does the drug Certolizumab differ from other treatments for pregnancy complications due to APS?
Certolizumab is unique because it is a biologic drug that targets specific proteins in the immune system, potentially offering a different mechanism of action compared to traditional treatments like aspirin, heparin, or intravenous immunoglobulin (IVIg), which are more commonly used for managing pregnancy complications in APS.678910
What is the purpose of this trial?
This trial tests if adding certolizumab to usual treatment can improve pregnancy outcomes in women with APS and LAC. Certolizumab reduces inflammation, which may help improve blood flow to the placenta and lead to better pregnancy results. Certolizumab pegol has been identified as a promising treatment during pregnancy because it has no late active placental transfer and no clear signs of fetal harm.
Research Team
D. Ware Branch, MD
Principal Investigator
University of Utah
Eligibility Criteria
This trial is for pregnant women aged 18-40 with antiphospholipid syndrome (APS) and lupus anticoagulant (LAC), who are less than 8 weeks into their pregnancy. They must have a hematocrit >26% and no history of diabetes, multifetal gestation, certain infections like HIV or tuberculosis, high blood pressure at screening, or be on high doses of prednisone.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive certolizumab starting by 8 weeks and 6 days gestation, with doses at 2 and 4 weeks later, followed by every other week until 27 weeks and 6 days gestation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of pregnancy outcomes and adverse events
Postpartum Monitoring
Participants are monitored for any adverse outcomes or pertinent concerns related to the study intervention
Treatment Details
Interventions
- Certolizumab Pegol
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ware Branch
Lead Sponsor
David Ware Branch
Lead Sponsor
Hospital for Special Surgery, New York
Collaborator
University of Toronto
Collaborator
NYU Langone Health
Collaborator