RECRUITINGPhase 2INTERVENTIONAL
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
Certolizumab to Prevent Pregnancy Complications in High-Risk Patients With APS or SLE - (IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
- Laboratory hematocrit \>26% at time of screening.
the diagnosis of APS and LAC will be confirmed by one of the Co-PI's for each case by a review of the medical records.
Who Should NOT Join This Trial:
- 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;
a. More than 60 mg once daily in a tapering regimen or 20 mg once daily in a maintenance regimen for 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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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;
* 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.
the diagnosis of APS and LAC will be confirmed by one of the Co-PI's for each case by a review of the medical records.
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 for an autoimmune disorder, other than immune thrombocytopenia;
a. More than 60 mg once daily in a tapering regimen or 20 mg once daily in a maintenance regimen for 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
Treatments Being Tested
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.
Locations (3)
Hospital for Special Surgery
New York, New York, United States
University of Utah
Salt Lake City, Utah, United States
TRIO Advancing Reproductive Care
Toronto, Ontario, Canada