Comparison Between JAK Inhibitors and Traditional Treatment of Rheumatoid Arthritis

NCT ID: NCT07272850

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2026-10-20

Brief Summary

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].

Conditions

Rheumatoid Arthritis; Arthritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

JAK inhibitors and traditional treatment of rheumatoid arthritis

Intervention Type: DRUG

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:

1. 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

2. 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

3. Sample Size Calculation Based on determining the main outcome variable, the estimated

Interventions

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:

1. 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

2. 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

3. Sample Size Calculation Based on determining the main outcome variable, the estimated

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Gamal Mohamed Abd Elaal

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Asmaa Gamal mohamed, Master of Clinical Hematology

Role: CONTACT

asmaagamak2@gmail.com

+2 01091076754

Related Links

https://www.rheumatologyadvisor.com/cch/rheumatoid-arthritis-jak-inhibitors-upadacitinib-tofacitinib-baricitinib/

Related Info

Other Identifiers

JAK inhibitors in RA

Identifier Type: -

Identifier Source: org_study_id