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NCT Number: NCT06880146

Cross-validation of a Predictive Model of Response to Anti-TNF Alpha Based on Oxylipin Response in Rheumatoid Arthritis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood sample Truculture

Other

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 outcomes

  1. Whole Blood Oxylipin Response (WBOR)

    Time frame: Month 0

    i.e. the ability of the host's blood cells to produce oxylipins in response to an immune stimulus. A wide range of several dozen pro- and anti-inflammatory oxylipins secreted by stimulated blood cells.

  2. EULAR clinical response

    Time frame: Month 6

    EULAR clinical response (based on change in DAS28 score) assessed after 6 months of anti-TNFα treatment. EULAR non-responders are defined as RA patients who did not achieve a good or moderate EULAR response after 6 months of treatment, discontinued the drug, started a new bDMARD or increased the oral corticosteroid dose to more than 10 mg/d at the second visit.

Secondary outcomes

  1. Performance of the predictive response model

    Time frame: Month 0

    The predictive performance of the model in the validation study is evaluated and compared using a ROC curve (Receiver Operating Characteristic Curve).

  2. Polyunsaturated fat (PUFA) content of blood cells

    Time frame: Month 0

    PUFA content of blood cells (leukocytes, red blood cells and platelets) present in the cell pellet in the Truculture tube.

  3. Polyunsaturated fat (PUFA) content of blood cells

    Time frame: Month 6

    PUFA content of blood cells (leukocytes, red blood cells and platelets) present in the cell pellet in the Truculture tube.

  4. Cytokine response

    Time frame: Month 0

    Large panel of 21 cytokines characteristic of the inflammatory response and lymphocyte polarisation (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).

  5. Cytokine response

    Time frame: Month 6

    Large panel of 21 cytokines characteristic of the inflammatory response and lymphocyte polarisation (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).

  6. Whole Blood Oxylipin Response (WBOR)

    Time frame: Month 6

    a wide range of several dozen pro- and anti-inflammatory oxylipins secreted by stimulated blood cells

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

+33473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Immunology department, CHU Clermont-Ferrand
  • Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes
  • University of Southampton

Registry information

Acronym: OPERAVAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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