NCT05552105Completed
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.
Source: ClinicalTrials.gov · Last updated 6 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 16 Sept 2022
- Start date
- Sept 2022
- Primary completion date
- Jan 2025
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05552105
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From Sept 2022 to the primary completion date, Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Non-steroidal anti-inflammatory drugs (NSAIDs) treatment during the last 2 weeks before inclusion
Other illness
- Contra-indications to a biological DMARDS (current or recent cancer, active infection),
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.