IL-6, IL-12, IL-15 and IL-23 Expression Levels in Rheumatoid Arthritis Patients

Not yet recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Other: blood sample

• Registration Number: NCT06558305
• Lead Sponsor: Assiut University

Brief Summary

Rheumatoid Arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation and articular damage.

Continuous medical research has dramatically improved the outcomes for patients with RA. Traditional therapeutic approaches have relied on glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs) and disease modifying antirheumatic drugs (DMARDs) such as methotrexate, sulfasalazine or leflunomide. Glucocorticoids and NSAIDs interfere with the inflammatory cascades while DMARDs impede both the inflammatory and the destructive processes of RA.

These drugs, although efficient, are not specifically directed against inflammatory cells or cytokines and are associated with significant toxicity. The development of biologic DMARDs (bDMARDs), has been an important step forward. Their ability to neutralize specific cytokines or target distinct immune cells filled a gap in existing treatment options for RA. \[3\]. However, some patients still have only partial or no response to bDMARDs. More recently, a group of drugs has been developed that inhibit the janus kinase (JAK) family of intracellular tyrosine kinases, which transmit cytokine- mediated signals via the JAK-signal transducer and activator of transcription (STAT) pathway \[4\]. Baricitinib, with a selectivity to inhibit JAK1 and 2, has been FDA approved for RA in 2018 \[5\].

Many cytokines such IL-6, IL-12, IL-15, IL-23, (GM-CSF) and (IFNs) are associated with the pathogenesis of RA. These cytokines transduce signals via the JAK-STAT pathway.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Study Start: 2024-09
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age is at leasr18 years old,
• established RA diagnosis according to 2010 the American College of Rheumatology/European League against Rheumatism classification criteria

Exclusion Criteria

• Associated autoimmune diseases,
• connective tissue diseases,
• chronic liver or kidney diseases or
• genetic diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients on cDMARDS	blood sample	-
Control	blood sample	-
Patients on janus kinase (JAK) inhibitors	blood sample	-

Primary Outcome Measures

Name	Time	Method
assess the effect of cDMARD and Baricitinib (JAKi) therapy on gene expressions of IL-6, IL-12, IL-15 and, IL-23 in patients with RA relative to the healthy controls.	6 months	assess the effect of cDMARD and Baricitinib (JAKi) therapy on gene expressions of IL-6, IL-12, IL-15 and, IL-23 in patients with RA relative to the healthy controls.