Could a new drug save pregnancies in women with a rare blood disorder?

NCT ID NCT03152058

Recruiting now Disease control Sponsor: David Ware Branch Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding certolizumab (Cimzia) to standard care (heparin and aspirin) can prevent fetal death or early delivery in pregnant women with antiphospholipid syndrome (APS) and lupus anticoagulant. About 55 women will receive the drug early in pregnancy and be compared to a previous group. The goal is to see if this combination improves pregnancy outcomes.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Certolizumab pegol (Cimzia)
What this could lead to: If it works, this could reduce the risk of fetal death or early delivery in pregnant women with antiphospholipid syndrome.
What could go wrong: This is a small Phase 2 trial with no placebo group, so results may not be definitive. The drug may not improve outcomes and could have unknown risks in pregnancy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

antiphospholipid syndrome pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ANTIPHOSPHOLIPID SYNDROME IN PREGNANCY HIGH-RISK PREGNANCY LUPUS ANTICOAGULANT DISORDER PREGNANCY COMPLICATIONS

Contacts and locations

Locations

Hospital for Special Surgery
RECRUITING

New York, New York, 10021, United States
TRIO Advancing Reproductive Care
RECRUITING

Toronto, Ontario, M5G 2K4, Canada
University of Utah
RECRUITING

Salt Lake City, Utah, 84132, United States

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