IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

Recruiting Phase 2 Interventional Study
High Risk Pregnancy Pregnancy Complications Antiphospholipid Syndrome in Pregnancy Lupus Anticoagulant Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 40
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
55 (estimated)
Sponsor
David Ware Branch · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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.…
Contacts

Rose Peckham

801-585-7617

Rose.Peckham@hsc.utah.edu

CONTACT

Elizabeth Turner

801-585-0591

elizabeth.e.turner@hsc.utah.edu

CONTACT