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IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

NCT03152058 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Certolizumab Pegol

Certolizumab \[400 mg (given as two subcutaneous injections of 200mg) initially and 2 and 4 weeks later, followed by 200 mg every other week thereafter\] The 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.

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • NYU Langone Health

    collaborator OTHER

  • David Ware Branch

    lead OTHER

Principal Investigators

  • D. Ware Branch, MD · University of Utah

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-17
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03152058 on ClinicalTrials.gov