Rheumatoid ArthritisOPERAVALNCT06880146
Cross-validation of a Predictive Model of Response to Anti-TNF Alpha Based on Oxylipin Response in Rheumatoid Arthritis
A study testing Blood sample Truculture in people with Rheumatoid Arthritis, run by University Hospital, Clermont-Ferrand at 3 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Blood sample Truculture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Mar 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Anne TOURNADRE
Hopital Cochin, APHP
Paris, 75014
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Jérome Avouac
CHU Saint Etienne
Saint-Etienne, 42055
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Hubert Marotte
About this study
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Blood sample Truculture
- Keywords
- Rheumatoid, arthritis, Oxylipin, Cytokin, EULAR response, Polyunsaturated fat
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample TrucultureOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Other | Intervention : blood sample added to the standard blood test at visit Inclusion and Month 6. Receives: Other: Blood sample Truculture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 6
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Month 6
Whole Blood Oxylipin Response (WBOR)
a wide range of several dozen pro- and anti-inflammatory oxylipins secreted by stimulated blood cells
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes, Immunology department, CHU Clermont-Ferrand, University of Southampton
- Responsible party
- Sponsor
- Investigators
- Anne TOURNADRE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880146
- Sponsor's protocol ID
- RBHP 2024 TOURNADRE
- Acronym
- OPERAVAL
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-validation of a Predictive Model of Response to Anti-TNF Alpha Based on Oxylipin Response in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06880146
- Acronym / sponsor ID
- OPERAVAL / RBHP 2024 TOURNADRE
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid, arthritis, Oxylipin, Cytokin, EULAR response, Polyunsaturated fat
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes, Immunology department, CHU Clermont-Ferrand, University of Southampton
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort study
| Arm | Type | Receives |
|---|---|---|
| Cohort | Other | Other: Blood sample TrucultureIntervention : blood sample added to the standard blood test at visit Inclusion and Month 6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample Trucultureblood 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). | Other | Cohort |
Primary outcome
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.
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne TOURNADRE principal investigator
University Hospital, Clermont-Ferrand
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample Truculture in people with Rheumatoid Arthritis, run by University Hospital, Clermont-Ferrand at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole Blood Oxylipin Response (WBOR) (time frame: Month 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.