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

January 20, 2026 updated by: Nourhan Elsaeed Abdelmabod Elhaish, Tanta University

Prospective Evaluation of Baricitinib's Effects on Procoagulant State and Atherogenic Index in Rheumatoid Arthritis Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baricitinib
Drug: Baricitinib
Oral baricitinib administered in combination with methotrexate according to standard clinical practice
No Intervention: Conventional DMARD therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Monocyte-Derived Human Tissue Factor Level
Time Frame: Baseline and 3 months
Change in tissue factor level from baseline to 3 months after initiation of baricitinib therapy.
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Disease Activity Score (DAS28)
Time Frame: Baseline and 3 months
Change in DAS28 from baseline to 3 months.
Baseline and 3 months
Change in Total Cholesterol Level
Time Frame: Baseline and 3 months
Change in total cholesterol level from baseline to 3 months.
Baseline and 3 months
Change in Triglyceride Level
Time Frame: Baseline and 3 months
Change in triglyceride level from baseline to 3 months.
Baseline and 3 months
Change in HDL-Cholesterol Level
Time Frame: Baseline and 3 months
Change in HDL-C level from baseline to 3 months.
Baseline and 3 months
Change in LDL-Cholesterol Level
Time Frame: Baseline and 3 months
Change in LDL-C level from baseline to 3 months
Baseline and 3 months
Change in Atherogenic Index (TC/HDL-C)
Time Frame: Baseline and 3 months
Change in atherogenic index from baseline to 3 months.
Baseline and 3 months
Change in D-dimer Level
Time Frame: Baseline and 3 months
Change in D-dimer level from baseline to 3 months.
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAR-RA-TANTA-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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