NCT07357649

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
7mo left

Started Jan 2026

Shorter than P25 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 12, 2026

Last Update Submit

January 20, 2026

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change in Monocyte-Derived Human Tissue Factor Level

    Change in tissue factor level from baseline to 3 months after initiation of baricitinib therapy.

    Baseline and 3 months

Secondary Outcomes (7)

  • Change in Disease Activity Score (DAS28)

    Baseline and 3 months

  • Change in Total Cholesterol Level

    Baseline and 3 months

  • Change in Triglyceride Level

    Baseline and 3 months

  • Change in HDL-Cholesterol Level

    Baseline and 3 months

  • Change in LDL-Cholesterol Level

    Baseline and 3 months

  • +2 more secondary outcomes

Study Arms (2)

Baricitinib

EXPERIMENTAL
Drug: Baricitinib

Conventional DMARD therapy

NO INTERVENTION

Interventions

BaricitinibDRUG

Oral baricitinib administered in combination with methotrexate according to standard clinical practice

Baricitinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

baricitinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 22, 2026

Study Start

January 1, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)