Comparison Between JAK Inhibitors and Traditional Treatment of Rheumatoid Arthritis

Comparison Between Haematological Parameters and Musculoskeletal Ultrasound Findings of Rheumatoid Arthritis Patients Recieving JAK Inhibitors Versus Traditional Treatment

Rheumatoid arthritis (RA) is a chronic autoimmune disease that affects about 1% of the world's population [1]. The disease is characterized by synovial membrane inflammation. The impact of RA on quality of life is significant, as it can lead to considerable disability, reduced mobility, and an increased risk of additional health complications [2].

CsDMARDs are the first-line drugs for RA treatment, of which methotrexate (MTX) is the cornerstone drug and monotherapy is recommended as the first choice (3).

However, previous studies had shown that 50% of RA patients had poor treatment effect on methotrexate or inadequate response to re-medication after relapse, resulting in drug resistance (4), resulting in no significant relief of symptoms and still high disease activity. EULAR had indicated that interleukin-6 (IL-6) receptor inhibitors and JAK inhibitors may have advantages over other biological disease-modifying anti-rheumatic drugs (bDMARDs) in patients who were not suitable for csDMARDs (5) Therefore, JAK inhibitors is used as monotherapy or combination therapy, which would provide a new strategy for clinical treatment. A few researches evaluated the relationship between PLT, RBC, Hb, red blood cells-platelet ratio (RPR), and the hemoglobin-platelet ratio (HPR) and RA disease activity. There is growing evidence that metrics like RDW and MPV, as well as the platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and others have been considered to be accurate, reliable inflammatory biomarkers in autoimmune illnesses[6,7] US has proven itself to be a useful imaging method for assessing articular and periarticular inflammation in small and large joints throughout the last years High resolution musculoskeletal ultrasound (MSUS), incorporating power Doppler ultrasound (PDUS), has demonstrated to be significantly more accurate than clinical evaluation in visualizing the inflammatory process. Furthermore, relatively few studies have examined ankle joint involvement in individuals with RA who lack symptoms [8].

Study Overview

• Status: Not yet recruiting
• Conditions: Arthritis; Rheumatoid Arthritis
• Intervention / Treatment: Drug: JAK inhibitors and traditional treatment of rheumatoid arthritis

• Study Type: Observational
• Enrollment (Estimated): 72

Contacts and Locations

• Study Contact: Name: Asmaa Gamal mohamed, Master of Clinical Hematology; Phone Number: +2 01091076754; Email: asmaagamak2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Two groups (1)rheumatoid arthritis receiving JAK inhibitors . (2) rheumatoid arthritis receiving traditional treatement

Description

Inclusion Criteria:

• • RA patients based on the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classifcation criteria for RA.

  • Age; 18-60

Exclusion Criteria:

• • the presence of other autoimmune diseases (e.g., systemic lupus erythematosus or psoriatic arthritis),

  • history of active infections, malignancy, or chronic diseases affecting hematological
  • parameters (e.g., anemia unrelated to RA, chronic kidney disease)
  • RA patients in remission
  • pregnant and lactating female patients

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Two groups (1)rheumatoid arthritis receiving JAK inhibitors . (2) rheumatoid arthritis receiving tra

Drug: JAK inhibitors and traditional treatment of rheumatoid arthritis; Type of the study: cross sectional study; two groups (1)rheumatoid arthritis receiving JAK inhibitors . (2) rheumatoid arthritis receiving traditional treatement 2.4. 2- Study Setting: Internal medicine department ,out patient rheumatology clinics of assuit university hospitals 2.4.3- study duration : October 2025 to October 2026 2.4. 4- Study subjects: Inclusion criteria:RA patients based on the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classifcation criteria for RA.Age; 18-60; Exclusion criteria:the presence of other autoimmune diseases (e.g., systemic lupus erythematosus or psoriatic arthritis),history of active infections, malignancy, or chronic diseases affecting hematologicalparameters (e.g., anemia unrelated to RA, chronic kidney disease)RA patients in remissionpregnant and lactating female patients; Sample Size Calculation Based on determining the main outcome variable, the estimated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in hematological parameters as MLR	MLR were determined by dividing the abso- lute neutrophil count by the absolute lymphocyte count, the absolute platelet count by the absolute lymphocyte count, and the absolute monocyte count by the absolute lymphocyte count, respec- tively	1 year
improvement in musculoskeletal ultrasound scores.		1 year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): October 20, 2026

Study Registration Dates

• First Submitted: October 2, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Pharmacologic Actions; Chemical Actions and Uses; Janus Kinase Inhibitors
• Other Study ID Numbers: JAK inhibitors in RA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No