Actively Recruiting
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
Led by David Ware Branch · Updated on 2026-04-01
55
Participants Needed
3
Research Sites
550 weeks
Total Duration
On this page
Sponsors
D
David Ware Branch
Lead Sponsor
H
Hospital for Special Surgery, New York
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant with a positive test for elevated ß-HCG and a live, appropriately sized embryo by ultrasound, less than 8 weeks gestation
- Diagnosis of antiphospholipid syndrome (APS)
- Positive lupus anticoagulant (LAC) test on two or more occasions at least 12 weeks apart within the previous 18 months, or newly diagnosed with APS and one positive LAC confirmed by medical record
- Age between 18 and 40 years and able to give informed consent
- Hematocrit greater than 26% at time of screening
- Diagnosis of APS and LAC confirmed by study investigators through medical record review
You will not qualify if you...
- High blood pressure (greater than 140/90) at screening
- Pregnancy with multiple fetuses
- Type 1 or Type 2 diabetes diagnosed before pregnancy
- Systemic lupus erythematosus (SLE) patients requiring prednisone over 10 mg per day
- Platelet count less than 100,000 per microliter
- Current prednisone use over 10 mg daily for autoimmune disorders except immune thrombocytopenia within specified dosing limits
- Urine protein excretion over 500 mg per day or protein/creatinine ratio over 0.5
- Serum creatinine over 1.2 mg/dL
- History of tuberculosis or untreated positive tuberculosis skin test
- Tuberculin skin test induration of 5 mm or greater or positive quantiFERON-gold test
- Positive status for HIV, Hepatitis B, or Hepatitis C
- Known contraindications to certolizumab including active or recurrent infections, history of certain fungal infections, heart failure, peripheral demyelinating disease or Guillain-Barre syndrome, hematologic cancer, or previous adverse reaction to certolizumab or other anti-TNF-alpha agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
2
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
3
TRIO Advancing Reproductive Care
Toronto, Ontario, Canada, M5G 2K4
Actively Recruiting
Research Team
R
Rose Peckham
CONTACT
E
Elizabeth Turner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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