Cross-validation of a Predictive Model of Response to Anti-TNF Alpha Based on Oxylipin Response in Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample Truculture.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this clinical trial is to use a blood test to predict whether a participant diagnosed with rheumatoid arthritis will respond to anti-TNF alpha treatment . The main questions it aims to answer is: Is the predictive model created using oxylipins effective? Participants starting anti-TNF alpha treatment will have a blood sample taken before starting treatment and 6 months afterwards.
Interventions
- Other Blood sample Truculture
blood sample added to the standard blood test at visit Inclusion and Month 6. This project will use the TruCulture® Whole Blood Stimulation System to assess the Whole Blood Oxylipin Response (WBOR). WBOR is the ability of patients to produce oxylipins in response to an immune stimulus. One tube is conditioned with LPS stimulant and a control tube is conditioned with no stimulant (Null).
Primary outcome measures
- Whole Blood Oxylipin Response (WBOR) [Time frame: Month 0]
- EULAR clinical response [Time frame: Month 6]
Secondary outcome measures (6)
- Performance of the predictive response model [Time frame: Month 0]
- Polyunsaturated fat (PUFA) content of blood cells [Time frame: Month 0]
- Polyunsaturated fat (PUFA) content of blood cells [Time frame: Month 6]
- Cytokine response [Time frame: Month 0]
- Cytokine response [Time frame: Month 6]
- Whole Blood Oxylipin Response (WBOR) [Time frame: Month 6]
Eligibility criteria
Inclusion criteria
- Male or female patient aged 18 years or older with rheumatoid arthritis according to ACR EULAR 2010 criteria
- Active disease as defined by DAS-28-CRP>3.2
- Naive to targeted biologic or synthetic therapy
- Rheumatologist's decision to start anti-TNFα treatment
- Stable corticosteroid therapy ≤ 10 mg/day
- Patient enrolled in or benefiting from a social security scheme
- Patient who has given written informed consent to participate in the study
Exclusion criteria
- Contraindication to biological treatment (cancer or history of cancer)
- Treatment with non-steroidal anti-inflammatory drugs in the 2 weeks prior to enrolment
- Protected persons (pregnant and/or breastfeeding women, persons under guardianship or conservatorship)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 3 centers
- CHU Clermont-Ferrand — Clermont-Ferrand
- Hopital Cochin, APHP — Paris
- CHU Saint Etienne — Saint-Etienne
Identifiers
NCT: NCT06880146 · RBHP 2024 TOURNADRE