Prospective Evaluation of Baricitinib's Effects on Procoagulant State and Atherogenic Index in Rheumatoid Arthritis Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
研究概览
简要总结
This prospective interventional study aims to evaluate the effects of baricitinib on disease activity, lipid profile, atherogenic index, and procoagulant biomarkers including monocyte-derived human tissue factor and D-dimer in patients with rheumatoid arthritis, compared with conventional therapy.
详细描述
Rheumatoid arthritis is a chronic systemic inflammatory disease associated with increased cardiovascular and thrombotic risk. Baricitinib, a Janus kinase 1 and 2 inhibitor, is approved for the treatment of moderate to severe rheumatoid arthritis; however, concerns remain regarding its potential prothrombotic effects.
In this prospective study, patients with rheumatoid arthritis will be recruited from Tanta University Hospitals and allocated into two parallel groups. The intervention group will receive baricitinib in combination with methotrexate after failure of conventional therapy, while the control group will continue conventional treatment.
Clinical assessment, disease activity score (DAS28), functional status (MHAQ), lipid profile, atherogenic index, monocyte-derived human tissue factor, and D-dimer levels will be evaluated at baseline and after three months to assess thrombotic risk and cardiovascular safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged ≥ 18 years.
- •Diagnosis of rheumatoid arthritis according to the ACR/EULAR 2010 criteria.
- •Patients with active rheumatoid arthritis despite conventional treatment.
- •Ability to provide written informed consent.
排除标准
- •Presence of other autoimmune diseases.
- •Diabetes mellitus.
- •Dyslipidemia or use of lipid-lowering therapy within the last 6 months.
- •Chronic kidney disease.
- •Chronic liver disease.
- •Chronic respiratory disease.
- •History of malignancy.
- •Pregnancy or breastfeeding.
- •Alcohol or drug abuse.
- •Acute or chronic infection.
- •Current prednisone dose > 7.5 mg/day.
- •History of arterial or venous thrombosis.
- •Use of anticoagulant or antithrombotic drugs within the last 3 months.
研究者
Nourhan Elsaeed Abdelmabod Elhaish
Principal Investigator
Tanta University