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 takingHeparinLow-dose aspirin
Must not be takingPrednisone
Rules you outHypertensionMultifetal 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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Status
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.…
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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