Certolizumab to Prevent Pregnancy Complications in High-Risk Patients With APS or SLE - (IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy)

NCT03152058 Phase 2 RECRUITING

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.

Details

Lead sponsor	David Ware Branch
Phase	Phase 2
Status	RECRUITING
Enrolment	55
Start date	2017-05-17
Completion	2027-12

Conditions

• High Risk Pregnancy
• Pregnancy Complications
• Antiphospholipid Syndrome in Pregnancy
• Lupus Anticoagulant Disorder

Interventions

• Certolizumab Pegol

Primary outcomes

• Fetal death and/or preterm delivery (<34 weeks) due to PE or PI in women with APS and LAC — 8 weeks gestation through 6-weeks postpartum
  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.

Countries

United States, Canada