NCT05552105

The Oxylipin Response as a New PrEdictive Biomarker of Patient Responsiveness to Biotherapy in Rheumatoid Arthritis (OPERA)

The Oxylipin Response as a New PrEdictive Biomarker of Patient Responsiveness to Biotherapy in Rheumatoid Arthritis.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

OPERA aims to better understand and predict the responsiveness of rheumatoid arthrits (RA) patients to biological disease modifying anti-rheumatic drugs (bDMARDs). Our objectives will be (i) to determine, at baseline, the differences of oxylipin response between responders vs non-responders to Anti-Tumor necrosis factor (Anti TNF) and (ii) to investigate the relationships between the oxylipin response, the polyunsatured fatty acid (PUFA) content of immune cells and the cytokine response.

Detailed description

30 RA patients starting an anti-TNF will be recruited. Before and after 6-months of anti-TNF treatment, blood will be collected using the TruCulture system (2x 1ml in non-stimulated and Lipopolysaccharide (LPS)-stimulated TruCulture tubes) to measure Whole Blood Oxylipin Response (WBOR), cytokine response, PUFA cell content and gene expression under homeostatic and stimulated conditions (i.e. LPS). At baseline and after 6 months of treatment, the rheumatologist will perform a clinical evaluation of their RA patients using Disease Activity Score using 28 joint-count (DAS28-CRP). Non-responders will be defined as RA patients failing to achieve good or moderate EULAR response after 6 month of anti-TNF treatment, discontinued the drug, initiated a new bDMARD, or increased dosage of oral corticosteroids greater than 10 mg/d at the second visit.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
OTHER	Blood test	Before and after 6-months of anti TNF treatment, blood will be collected using the TruCulture system (2x 1ml in non-stimulated and LPS-stimulated TruCulture tubes) to measure Whole Blood Oxylipin Response, cytokine response, PUFA cell content and gene expression under homeostatic and stimulated conditions (i.e. LPS)

Timeline

• Start date: 2022-09-27
• Primary completion: 2025-01-28
• Completion: 2025-01-28
• First posted: 2022-09-23
• Last updated: 2025-03-06

Locations

1 site across 1 country: France