Rheumatoid Arthritis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGBaricitinib
Oral baricitinib administered in combination with methotrexate according to standard clinical practice
Sponsors
Tanta University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Monocyte-Derived Human Tissue Factor Level | Baseline and 3 months | Change in tissue factor level from baseline to 3 months after initiation of baricitinib therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Activity Score (DAS28) | Baseline and 3 months | Change in DAS28 from baseline to 3 months. |
| Change in Total Cholesterol Level | Baseline and 3 months | Change in total cholesterol level from baseline to 3 months. |
| Change in Triglyceride Level | Baseline and 3 months | Change in triglyceride level from baseline to 3 months. |
| Change in HDL-Cholesterol Level | Baseline and 3 months | Change in HDL-C level from baseline to 3 months. |
| Change in LDL-Cholesterol Level | Baseline and 3 months | Change in LDL-C level from baseline to 3 months |
| Change in Atherogenic Index (TC/HDL-C) | Baseline and 3 months | Change in atherogenic index from baseline to 3 months. |
| Change in D-dimer Level | Baseline and 3 months | Change in D-dimer level from baseline to 3 months. |
Countries
Egypt
Outcome results
None listed