IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

May 17, 2017

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
High Risk PregnancyPregnancy ComplicationsAntiphospholipid Syndrome in PregnancyLupus 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."

Trial Locations (3)

10021

RECRUITING

Hospital for Special Surgery, New York

84132

RECRUITING

University of Utah, Salt Lake City

M5G 2K4

RECRUITING

TRIO Advancing Reproductive Care, Toronto

All Listed Sponsors
collaborator

Hospital for Special Surgery, New York

OTHER

collaborator

University of Toronto

OTHER

collaborator

NYU Langone Health

OTHER

lead

David Ware Branch

OTHER