Clinical trial NCT05552105: The Oxylipin Response as a New PrEdictive Biomarker of Patient Responsiveness to Biotherapy in Rheumatoid Arthritis (OPERA)
Official title: The Oxylipin Response as a New PrEdictive Biomarker of Patient Responsiveness to Biotherapy in Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Anti TNF
Oxylipin
Cytokine
Polyunsatured fatty acid
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: University of Southampton
First posted: 2022-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantification of total oxylipins
timeFrame: Baseline
Secondary outcomes:
measure: Quantification of polyunsatured fatty acids in blood cells
timeFrame: Baseline
measure: Quantification of cytokines
timeFrame: Baseline
measure: EULAR Response
timeFrame: 6 month
measure: Quantification of total oxylipins
timeFrame: 6 month
measure: Quantification of cytokines
timeFrame: 6 month
measure: Quantification of polyunsatured fatty acids in blood cells
timeFrame: 6 month
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: