NCT03152058 IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
| NCT ID | NCT03152058 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | David Ware Branch |
| Condition | High Risk Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2017-05-17 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 55 participants in total. It began in 2017-05-17 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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. 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
Contact & Investigator
D. Ware Branch, MD
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT03152058 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying High Risk Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03152058 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03152058 currently recruiting?
Yes, NCT03152058 is actively recruiting participants. Contact the research team at Rose.Peckham@hsc.utah.edu for enrollment information.
Where is the NCT03152058 trial being conducted?
This trial is being conducted at New York, United States, Salt Lake City, United States, Toronto, Canada.
Who is sponsoring the NCT03152058 clinical trial?
NCT03152058 is sponsored by David Ware Branch. The principal investigator is D. Ware Branch, MD at University of Utah. The trial plans to enroll 55 participants.