An observational study in Rheumatoid Arthritis, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by Assiut University · Observational
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.
2,963 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's planned enrollment of 80 is below the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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this study will include 30 RA patients receiving cDMARDs, 30 RA patients receiving baricitinib and 20 healthy participants.
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Exclusion Criteria:
Other: blood sample
Other: blood sample
Other: 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.
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.
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.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Mar 2025, 6 months later.
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This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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