Rheumatoid ArthritisPhase 4BAR-RANCT07357649
Baricitinib Effects on Procoagulant State in Rheumatoid Arthritis
A Phase 4 study testing Baricitinib in people with Rheumatoid Arthritis, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2026to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Tanta University Hospitals
Tanta
Tanta University Hospitals, +020403337544, mailto:vp_research@unv.tanta.edu.eg
About this study
Official title: 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.
Read the 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
- Rheumatoid Arthritis
- Being tested
- Baricitinib
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Oral baricitinib administered in combination with methotrexate according to standard clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib | Experimental | Not described Receives: Drug: Baricitinib |
| Conventional DMARD therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Monocyte-Derived Human Tissue Factor Level
Change in tissue factor level from baseline to 3 months after initiation of baricitinib therapy.
Measured: Baseline and 3 months
Secondary outcomes (7)
Change in Disease Activity Score (DAS28)
Change in DAS28 from baseline to 3 months.
Measured: Baseline and 3 months
Change in Total Cholesterol Level
Change in total cholesterol level from baseline to 3 months.
Measured: Baseline and 3 months
Change in Triglyceride Level
Change in triglyceride level from baseline to 3 months.
Measured: Baseline and 3 months
Change in HDL-Cholesterol Level
Change in HDL-C level from baseline to 3 months.
Measured: Baseline and 3 months
Change in LDL-Cholesterol Level
Change in LDL-C level from baseline to 3 months
Measured: Baseline and 3 months
Change in Atherogenic Index (TC/HDL-C)
Change in atherogenic index from baseline to 3 months.
Measured: Baseline and 3 months
Change in D-dimer Level
Change in D-dimer level from baseline to 3 months.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Elsaeed Abdelmabod Elhaish, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357649
- Sponsor's protocol ID
- BAR-RA-TANTA-2025
- Acronym
- BAR-RA
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Baricitinib's Effects on Procoagulant State and Atherogenic Index in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT07357649
- Acronym / sponsor ID
- BAR-RA / BAR-RA-TANTA-2025
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baricitinib | Experimental | Drug: Baricitinib |
| Conventional DMARD therapy | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibOral baricitinib administered in combination with methotrexate according to standard clinical practice | Drug | Baricitinib |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baricitinib in people with Rheumatoid Arthritis, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Monocyte-Derived Human Tissue Factor Level (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.