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

NCT ID: NCT06558305

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-04-30

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients on cDMARDS

blood sample

Intervention Type OTHER

Total RNA will be extracted from the whole blood using a commercial extraction kit (RNA Extraction Kit, applied biotechnology Co.Ltd, Egypt) according to the manufacturer's instructions. RNA will be stored at -80°C.The extracted RNA will be used for cDNA synthesis using commercial kits (cDNA Synthesis Kit, applied biotechnology Co.Ltd, Egypt), according to the manufacturer's instruction.

Patients on janus kinase (JAK) inhibitors

blood sample

Intervention Type OTHER

Total RNA will be extracted from the whole blood using a commercial extraction kit (RNA Extraction Kit, applied biotechnology Co.Ltd, Egypt) according to the manufacturer's instructions. RNA will be stored at -80°C.The extracted RNA will be used for cDNA synthesis using commercial kits (cDNA Synthesis Kit, applied biotechnology Co.Ltd, Egypt), according to the manufacturer's instruction.

Control

blood sample

Intervention Type OTHER

Total RNA will be extracted from the whole blood using a commercial extraction kit (RNA Extraction Kit, applied biotechnology Co.Ltd, Egypt) according to the manufacturer's instructions. RNA will be stored at -80°C.The extracted RNA will be used for cDNA synthesis using commercial kits (cDNA Synthesis Kit, applied biotechnology Co.Ltd, Egypt), according to the manufacturer's instruction.

Interventions

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blood sample

Total RNA will be extracted from the whole blood using a commercial extraction kit (RNA Extraction Kit, applied biotechnology Co.Ltd, Egypt) according to the manufacturer's instructions. RNA will be stored at -80°C.The extracted RNA will be used for cDNA synthesis using commercial kits (cDNA Synthesis Kit, applied biotechnology Co.Ltd, Egypt), according to the manufacturer's instruction.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Maha Sayed Ibrahim Abdelrahman

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Interleukins in RA patients

Identifier Type: -

Identifier Source: org_study_id

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