RECRUITING

IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Certolizumab to Prevent Pregnancy Complications in High-Risk Patients With APS or SLE - (IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy)

Quick Facts

Study Start:2017-05-17

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03152058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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; * 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

Inclusion Criteria

Exclusion 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.

* 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;
* 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

Contacts and Locations

Study Contact

Joseph Worden

CONTACT

801-585-7617

joseph.worden@hsc.utah.edu

Elizabeth Turner

CONTACT

801-585-0591

elizabeth.e.turner@hsc.utah.edu

Principal Investigator

D. Ware Branch, MD

PRINCIPAL_INVESTIGATOR

University of Utah

Study Locations (Sites)

Hospital for Special Surgery

New York, New York, 10021

United States

University of Utah

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: David Ware Branch

D. Ware Branch, MD, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-05-17

Study Completion Date2025-12

Study Record Updates

Study Start Date2017-05-17

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

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