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

Last updated: March 4, 2025
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Completed

Phase

N/A

Condition

Rheumatoid Arthritis

Musculoskeletal Diseases

Dermatomyositis (Connective Tissue Disease)

Treatment

Blood test

Clinical Study ID

NCT05552105
RBHP 2022 TOURNADRE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Rheumatoid patient according to ACR-EULAR (American college of rheumatology-EuropeanLeague Against Rheumatism) 2010 criteria,

  • Active disease defined by a DAS28-CRP>3.2,

  • Biological and targeted synthetic DMARDs naïve,

  • Indication for treatment with anti-TNF

  • Stable corticosteroid therapy ≤ 10 mg/day

Exclusion

Exclusion Criteria:

  • Contra-indications to a biological DMARDS (current or recent cancer, activeinfection),

  • Non-steroidal anti-inflammatory drugs (NSAIDs) treatment during the last 2 weeksbefore inclusion

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Blood test
Phase:
Study Start date:
September 27, 2022
Estimated Completion Date:
January 28, 2025

Study 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.

Connect with a study center

  • CHU Clermont-Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

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