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.
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