Improving pregnancy outcomes in women with antiphospholipid syndrome using certolizumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of certolizumab, an anti-tumor necrosis factor-alpha drug, in improving pregnancy outcomes for women with antiphospholipid syndrome (APS) and positive lupus anticoagulant tests. Participants will receive certolizumab in addition to standard treatment with heparin and low-dose aspirin. The study aims to determine if this combination therapy can reduce adverse pregnancy outcomes, such as fetal loss and preterm birth, by addressing inflammation and improving placental vascularization. Outcomes will be compared to data from a previous observational study involving similar patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital for Special Surgery
  New York, New York, United States Recruiting
• University of Utah
  Salt Lake City, Utah, United States Recruiting
• TRIO Advancing Reproductive Care
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: D. Ware Branch, MD — University of Utah
• Study coordinator: Rose Peckham
• Email: Rose.Peckham@hsc.utah.edu
• Phone: 801-585-7617

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.