IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 40 Years

Healthy Volunteers

Not accepted

Interventions

• Certolizumab Pegol — DRUG
  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.

Study Details

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.

Key Dates

Start date

May 17, 2017

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

55 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Certolizumab Pegol
  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.

Primary Outcome Measure

Fetal death and/or preterm delivery (<34 weeks) due to PE or PI in women with APS and LAC [ Time Frame: 8 weeks gestation through 6-weeks postpartum ]

Central Contacts

• Rose Peckham
  801-585-7617
  [email protected]
• Elizabeth Turner
  801-585-0591
  [email protected]

Locations (2)

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