Baricitinib Effects on Procoagulant State in Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Baricitinib.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Evaluation of Baricitinib's Effects on Procoagulant State and Atherogenic Index in Rheumatoid Arthritis Patients
Overview
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
- Drug Baricitinib
Oral baricitinib administered in combination with methotrexate according to standard clinical practice
Primary outcome measures
- Change in Monocyte-Derived Human Tissue Factor Level [Time frame: Baseline and 3 months]
Secondary outcome measures (7)
- Change in Disease Activity Score (DAS28) [Time frame: Baseline and 3 months]
- Change in Total Cholesterol Level [Time frame: Baseline and 3 months]
- Change in Triglyceride Level [Time frame: Baseline and 3 months]
- Change in HDL-Cholesterol Level [Time frame: Baseline and 3 months]
- Change in LDL-Cholesterol Level [Time frame: Baseline and 3 months]
- Change in Atherogenic Index (TC/HDL-C) [Time frame: Baseline and 3 months]
- Change in D-dimer Level [Time frame: Baseline and 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University Hospitals — Tanta
Identifiers
NCT: NCT07357649 · BAR-RA-TANTA-2025