EUCTR2020-001177-78-FR进行中（未招募）1 期
Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with APS or SLE - IMPACT
niversity of Utah0 个研究点目标入组 50 人开始时间: 2020年4月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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.
研究者
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