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New treatment option for High Risk Pregnancy
Official title IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
ClinicalTrials.gov ID: NCT03152058
What this study is testing
What is Certolizumab Pegol?
Certolizumab Pegol is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for high risk pregnancy.
Also referred to as Cimzia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
See the full eligibility 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...
- 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.
- 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...
- 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:
- Active infection, e.g., chronic hepatitis B
- History of recurrent infection, e.g., recurrent cellulitis, or opportunistic infection
- History of prior active/treated endemic mycoses in the last two years (including coccidioidomycosis, blastomycosis, or histoplasmosis)
- History of heart failure
- History of peripheral demyelinating disease or Guillian-Barre syndrome
- History of hematologic malignancy
- Prior adverse reaction to certolizumab or o ther anti-TNF-α agent
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Salt Lake City, Utah, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Salt Lake City, Utah, United States; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.