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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Oral baricitinib administered in combination with methotrexate according to standard clinical practice
Tanta University Hospitals
Tanta, Egypt
Change in Monocyte-Derived Human Tissue Factor Level
Change in tissue factor level from baseline to 3 months after initiation of baricitinib therapy.
Time frame: Baseline and 3 months
Change in Disease Activity Score (DAS28)
Change in DAS28 from baseline to 3 months.
Time frame: Baseline and 3 months
Change in Total Cholesterol Level
Change in total cholesterol level from baseline to 3 months.
Time frame: Baseline and 3 months
Change in Triglyceride Level
Change in triglyceride level from baseline to 3 months.
Time frame: Baseline and 3 months
Change in HDL-Cholesterol Level
Change in HDL-C level from baseline to 3 months.
Time frame: Baseline and 3 months
Change in LDL-Cholesterol Level
Change in LDL-C level from baseline to 3 months
Time frame: Baseline and 3 months
Change in Atherogenic Index (TC/HDL-C)
Change in atherogenic index from baseline to 3 months.
Time frame: Baseline and 3 months
Change in D-dimer Level
Change in D-dimer level from baseline to 3 months.
Time frame: Baseline and 3 months
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