Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with Antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE)

Phase 1

• Conditions: Pregnant women with Antiphospholipid Syndrom (APS) and Lupus Antocoagulant (LAC); MedDRA version: 20.0Level: PTClassification code 10002817Term: Antiphospholipid syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.1Level: LLTClassification code 10058347Term: Lupus anticoagulant positiveSystem Organ Class: 100000004848; MedDRA version: 20.0Level: LLTClassification code 10058355Term: Lupus anticoagulantSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-001177-78-FR
• Lead Sponsor: niversity of Utah

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-09
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Pregnant as defined by positive test for elevated ß-HCG and having a live, appropriate-size embryo by ultrasound, but < 8 weeks gestation;
2. Antiphospholipid syndrome (APS)
3. Positive LAC, on two or more occasions greater than 12 weeks apart, one of which must be 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.
4. Age 18-40 (+364 days) years of age and able to give informed consent;
5. Laboratory hematocrit > 26% at time of screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Hypertension (BP >140/90) present at screening;
2. Multifetal gestation;
3. Type 1 or type 2 diabetes antedating pregnancy;
4. SLE patients requiring prednisone >10 mg/day;
5. Platelet count <100,000 per microliter;
6. Women currently taking prednisone greater than 10 mg daily for an autoimmune disorder, other than immune thrombocytopenia; More than 60 mg once daily in a tapering regimen or 20 mg once daily in a maintenance regimen for immune thrombocytopenia
7. Women with urinary excretion with greater than 500 mg (0.5 g) per day (spot urine protein/creatinine ratio 0.5);
8. Serum creatinine >1.2 mg/dL;
9. History of tuberculosis or untreated positive PPD;
10. Women with a tuberculin skin test induration of 5 mm or greater; or positive quantiFERON-gold test
11. Women with HIV, Hepatitis B or Hepatitis C positive status;
12. Concomitant participation in another interventional research study;
13. Known contraindications or relative contraindications to certolizumab :
a. Active infection, e.g., chronic hepatitis B.
b. History of recurrent infection, e.g., recurrent cellulitis, or opportunistic infection.
c. History of prior active/treated endemic mycoses in the last two years (including coccidioidomycosis, blastomycosis, or histoplasmosis).
d. History of heart failure.
e. History of peripheral demyelinating disease or Guillian-Barré syndrome.
f. History of hematologic malignancy.
g. Prior adverse reaction to certolizumab or other anti-TNF-a agent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified