Trials / Not Yet Recruiting
Not Yet RecruitingNCT07357649
Baricitinib Effects on Procoagulant State in Rheumatoid Arthritis
Prospective Evaluation of Baricitinib's Effects on Procoagulant State and Atherogenic Index in Rheumatoid Arthritis Patients
- Status
- Not Yet Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Tanta University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Baricitinib | Oral baricitinib administered in combination with methotrexate according to standard clinical practice |
Timeline
- Start date
- 2026-01-01
- Primary completion
- 2026-04-01
- Completion
- 2026-12-01
- First posted
- 2026-01-22
- Last updated
- 2026-01-22
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT07357649. Inclusion in this directory is not an endorsement.