Certolizumab for Antiphospholipid Syndrome in Pregnancy

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.
Ready to participate?

Review the details below, then apply to join this clinical 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
Who this trial is looking for

This trial is looking for pregnant women who have antiphospholipid syndrome and positive tests for lupus anticoagulant. Participants will receive certolizumab in addition to their usual treatments to see if it improves their pregnancy outcomes.

Are You a Good Fit for This Trial?
Must be taking HeparinLow-dose aspirin
Must not be taking Prednisone
Rules you out HypertensionMultifetal gestationType 1 diabetesType 2 diabetesHistory of heart failureHistory of peripheral demyelinating diseaseHistory of hematologic malignancy

You may be able to join if

  • I am pregnant and less than 8 weeks along.
  • I have been diagnosed with antiphospholipid syndrome (APS).
  • I have tested positive for lupus anticoagulant (LAC) multiple times in the last 18 months.
  • I am between 18 and 40 years old.
  • I can provide informed consent.
  • My hematocrit level is above 26%.

You may not be able to join if

  • I have high blood pressure.
  • I am pregnant with more than one baby.
  • I have diabetes that started before my pregnancy.
  • I am taking more than 10 mg of prednisone daily.
  • My platelet count is below 100,000.
  • I have a history of tuberculosis or untreated positive PPD.
  • I have HIV, Hepatitis B, or Hepatitis C.
  • I have had serious infections or adverse reactions to certolizumab before.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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