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

NCT ID NCT03152058

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 55 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2017

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. If a candidate for the study is newly diagnosed (\<12 weeks) with APS, meets clinical criteria for APS and has one positive LAC confirmed by review of the medical record, she may be consented and screened. At baseline, LAC will be measured at the study core lab and she will be enrolled if it is found to be positive. The LAC measurement will be repeated 12 weeks after the initial determination and, if positive, she will remain in the study. * Age 18-40 (+364 days) years of age and able to give informed consent * Laboratory hematocrit \>26% at time of screening. the diagnosis of APS and LAC will be confirmed by one of the Co-PI's for each case by a review of the medical records. Exclusion Criteria: * Hypertension (BP \>140/90) present at screening; * Multifetal gestation; * Type 1 or Type 2 diabetes antedating pregnancy; * SLE patients requiring prednisone \>10 mg/day; * Platelet count \<100,000 per microliter; * Women currently taking prednisone greater than 10 mg daily for an autoimmune disorder, other than immune thrombocytopenia; a. More than 60 mg once daily in a tapering regimen or 20 mg once daily in a maintenance regimen for immune thrombocytopenia * Women with urinary excretion with greater than 500 mg (0.5 g) per day (spot urine protein/creatinine ration 0.5); * Serum creatinine \>1.2 mg/dL * History of tuberculosis or untreated positive PPD; * Women with a tuberculin skin test induration of 5 mm or greater; or positive quantiFERON-gold test * Women with HIV, Hepatitis B or Hepatitis C positive status; * Known contraindications or relative contraindications to certolizumab: 1. Active infection, e.g., chronic hepatitis B 2. History of recurrent infection, e.g., recurrent cellulitis, or opportunistic infection 3. History of prior active/treated endemic mycoses in the last two years (including coccidioidomycosis, blastomycosis, or histoplasmosis) 4. History of heart failure 5. History of peripheral demyelinating disease or Guillian-Barre syndrome 6. History of hematologic malignancy 7. Prior adverse reaction to certolizumab or o ther anti-TNF-α agent

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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