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| Name | Class |
|---|---|
| Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes | UNKNOWN |
| Immunology department, CHU Clermont-Ferrand | UNKNOWN |
| University of Southampton | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Other | Intervention : blood sample added to the standard blood test at visit Inclusion and Month 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Whole Blood Oxylipin Response (WBOR) | 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. | Month 0 |
| EULAR clinical response | 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. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the predictive response model | The predictive performance of the model in the validation study is evaluated and compared using a ROC curve (Receiver Operating Characteristic Curve). | Month 0 |
| Polyunsaturated fat (PUFA) content of blood cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | +33473754963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne TOURNADRE | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Cohort study
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|
PUFA content of blood cells (leukocytes, red blood cells and platelets) present in the cell pellet in the Truculture tube. |
| Month 0 |
| Polyunsaturated fat (PUFA) content of blood cells | PUFA content of blood cells (leukocytes, red blood cells and platelets) present in the cell pellet in the Truculture tube. | Month 6 |
| Cytokine response | 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). | Month 0 |
| Cytokine response | 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). | Month 6 |
| Whole Blood Oxylipin Response (WBOR) | a wide range of several dozen pro- and anti-inflammatory oxylipins secreted by stimulated blood cells | Month 6 |
| Hopital Cochin, APHP | Paris | 75014 | France |
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| CHU Saint Etienne | Saint-Etienne | 42055 | France |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |