RecruitingPhase 2

IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

United States, Canada55 participantsStarted 2017-05-17

Plain-language summary

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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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Exclusion criteria

✕. Active infection, e.g., chronic hepatitis B
✕. History of recurrent infection, e.g., recurrent cellulitis, or opportunistic infection
✕. History of prior active/treated endemic mycoses in the last two years (including coccidioidomycosis, blastomycosis, or histoplasmosis)
✕. History of heart failure
✕. History of peripheral demyelinating disease or Guillian-Barre syndrome
✕. History of hematologic malignancy
✕. Prior adverse reaction to certolizumab or o ther anti-TNF-α agent

What they're measuring

Fetal death and/or preterm delivery (<34 weeks) due to PE or PI in women with APS and LAC

Timeframe: 8 weeks gestation through 6-weeks postpartum

Trial details

NCT IDNCT03152058

SponsorDavid Ware Branch

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Rose Peckham

801-585-7617 Rose.Peckham@hsc.utah.edu

View on ClinicalTrials.gov More High Risk Pregnancy trials