Rheumatoid Arthritis
Conditions
Keywords
Anti TNF, Oxylipin, Cytokine, Polyunsatured fatty acid
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.
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.
Interventions
OTHERBlood 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)
Sponsors
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
University of Southampton
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Contra-indications to a biological DMARDS (current or recent cancer, active infection), * Non-steroidal anti-inflammatory drugs (NSAIDs) treatment during the last 2 weeks before inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of total oxylipins | Baseline | Quantitative profiling procedure for oxylipins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of polyunsatured fatty acids in blood cells | Baseline | Quantitative profiling procedure for polyunsatured fatty acids in blood cells (leukocytes, red blood cells and platelets) |
| Quantification of cytokines | Baseline | Large panel of 21 cytokines characteristic of the inflammatory response and lymphocyte polarization. (IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33, IL-5, IL-13, IL-2, IL-9, IL-10, IL-17F, IL-4, IL-22) |
| EULAR Response | 6 month | Non-responders will be defined as rheumatoid arthritis patients failing to achieve good or moderate EULAR response after 6 month of biological disease modifying anti rheumatic drug (bDMARD), discontinued the drug, initiated a new bDMARD, or increased dosage of oral corticosteroids greater than 10 mg/d at the second visit. EULAR response is determined by the decrease in Disease activity score (DAS) between Baseline and 6 months |
| Quantification of total oxylipins | 6 month | Quantitative profiling procedure for oxylipins |
Countries
France
Outcome results
None listed