Baricitinib Effects on Procoagulant State in Rheumatoid Arthritis (BAR-RA)

Tanta University

Status and phase: Not yet enrolling; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Baricitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT07357649

BAR-RA-TANTA-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Baricitinib

Experimental group

Treatment:

Drug: Baricitinib

Conventional DMARD therapy

No Intervention group