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## Study Description

Antiphospholipid syndrome (APS) is an autoimmune disorder that occurs most commonly in women of reproductive age and is associated with thrombosis and adverse pregnancy outcomes (APOs), such as fetal loss and preterm birth due to severe preeclampsia (PE) or placental insufficiency (PI). Traditional therapy for APS during pregnancy has been a heparin agent and low dose aspirin. However, in PROMISSE, a prospective observational study of 724 patients, 44% of pregnancies in women with APS and LAC resulted in APOs despite treatment with heparin and low dose aspirin.

Based on the observations in PROMISSE, this study hypothesizes that tumor necrosis factor-alpha blockade will significantly decrease the rate of fetal death and preterm delivery due to PE and PI in women with APS and LAC. The study aims to determine whether tumor necrosis factor-alpha blockade during pregnancy, added to a regimen of heparin and low dose aspirin, (1) reduces the rate of APOs in women with clinical APS and LAC, and (2) alters angiogenic markers of poor placental vascularization. 

**ELIGIBILITY CRITERIA:**

Ages Eligible for Study:           18 Years to 38 Years   (Adult)

Sexes Eligible for Study:          Female

Gender Based Eligibility:         Yes

Gender Eligibility Description:            Eligibility includes only pregnant women

Accepts Healthy Volunteers:  No

**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;
                      - APS and positive for LAC on two or more occasions greater than 12 weeks apart within the previous 18 months and confirmed by review of medical records and core laboratory testing (the diagnosis of APS and LAC will be confirmed by one of the Co-PIs for each case by a review of the medical records)
                      - Age 18-38 (+364 days) years of age and able to give informed consent
                      - Laboratory hematocrit >26% at time of screening.

**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;
                      - 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:

Active infection, e.g., chronic hepatitis B
                      - History of recurrent infection, e.g., recurrent cellulitis, or opportunistic infection
                      - History of prior active/treated endemic mycoses in the last two years (including coccidioidomycosis, blastomycosis, or histoplasmosis)
                      - History of heart failure
                      - History of peripheral demyelinating disease or Guillian-Barre syndrome
                      - History of hematologic malignancy
                      - Prior adverse reaction to certolizumab or o ther anti-TNF-α agent

**Study Design:**

Intervention Model: Single Group Assignment 

Masking: None (Open Label)

Primary Purpose: Prevention

**Study Location(s):**

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

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

TRIO Advancing Reproductive Care, Toronto, Ontario, Canada

**Study Website:**

https://clinicaltrials.gov/ct2/show/NCT03152058?term=NCT03152058&rank=1

August 2019

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