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

NCT05552105 | Completed

• 1 other identifier: RBHP 2022 TOURNADRE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Anti TNF; Oxylipin; Cytokine; Polyunsatured fatty acid

Outcome Measures

Primary Outcomes (1)

• Quantification of total oxylipins

  Quantitative profiling procedure for oxylipins

  Baseline

Secondary Outcomes (6)

• Quantification of polyunsatured fatty acids in blood cells

  Baseline

• Quantification of cytokines

  Baseline

• EULAR Response

  6 month

• Quantification of total oxylipins

  6 month

• Quantification of cytokines

  6 month

Study Arms (1)

Cohort

OTHER

Other: Blood test

Interventions

Blood test OTHER

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)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rheumatoid patient according to ACR-EULAR (American college of rheumatology-European League 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator
• University of Southampton: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 23, 2022
• Study Start: September 27, 2022
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2025
• Last Updated: March 6, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)