IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

Description

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

High Risk Pregnancy, Pregnancy Complications, Antiphospholipid Syndrome in Pregnancy, Lupus Anticoagulant Disorder

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Certolizumab to Prevent Pregnancy Complications in High-Risk Patients With APS or SLE - (IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy)

IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

Condition
High Risk Pregnancy
Intervention / Treatment

-

Contacts and Locations

New York

Hospital for Special Surgery, New York, New York, United States, 10021

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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 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.
  • * 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;
  • * 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

Ages Eligible for Study

18 Years to 40 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

David Ware Branch,

D. Ware Branch, MD, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

2025-12