IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
Key facts
- Who runs it
- David Ware Branch
- Where
- New York and Salt Lake City, United StatesSee the 2 sitesAlso in 1 other country, 1 site
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 55 people, planned
- Started
- 17 May 2017
- Expected to end
- Dec 2027
- Type of study
- Interventional
- Treatments tested
- Certolizumab Pegol
- Record updated
- 1 April 2026
Who can take part
- Age
- 18 years to 40 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Women currently taking prednisone greater than 10 mg daily for an autoimmune disorder, other than immune thrombocytopenia; More than 60 mg once daily in a tapering regimen or 20 mg once daily in a maintenance regimen for immune thrombocytopenia
- 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
- Hypertension (BP >140/90) present at screening
- Type 1 or Type 2 diabetes antedating pregnancy
- History of tuberculosis or untreated positive PPD
- Women with HIV, Hepatitis B or Hepatitis C positive status
- Platelet count <100,000 per microliter
- 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
- Multifetal gestation
- SLE patients requiring prednisone >10 mg/day
- Women with a tuberculin skin test induration of 5 mm or greater; or positive quantiFERON-gold test
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 40 years old?
Where in United States
Also in 1 other country, 1 site
- Hospital for Special SurgeryNew York, United StatesContact: Marta Guerra, MSTaking people
- University of UtahSalt Lake City, United StatesContact: Elizabeth TurnerTaking people
About the trial
What the trial wants 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 outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.
The group in the trial
- Certolizumab PegolTreatment being tested
All participants are administered certolizumab \[400 mg (given as two subcutaneous injections of 200mg) initially and 2 and 4 weeks later, followed by 200 mg every other week thereafter. 1st dose of certolizumab will be administered by 8 weeks and 6 days gestation and discontinued at 27 weeks 6 days. The regimen of heparin and low dose aspirin is a standard of care treatment for this patient population and is not considered part of the research intervention.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Certolizumab to Prevent Pregnancy Complications in High-Risk Patients With APS or SLE - (IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy)
- Fit questions
- Built from NCT03152058, who can take part
- Record updated
- 1 April 2026