NCT06880146

Brief 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 have a blood sample taken before starting treatment and 6 months afterwards.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
15mo left

Started Mar 2025

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Mar 2025Nov 2027

First Submitted

Initial submission to the registry

March 11, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

March 11, 2025

Last Update Submit

March 11, 2025

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid, arthritisOxylipinCytokinEULAR responsePolyunsaturated fat

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (6)

  • Performance of the predictive response model

    Month 0

  • Polyunsaturated fat (PUFA) content of blood cells

    Month 0

  • Polyunsaturated fat (PUFA) content of blood cells

    Month 6

  • Cytokine response

    Month 0

  • Cytokine response

    Month 6

  • +1 more secondary outcomes

Study Arms (1)

Cohort

OTHER

Intervention : blood sample added to the standard blood test at visit Inclusion and Month 6.

Other: Blood sample Truculture

Interventions

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).

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Hopital Cochin, APHP

Paris, 75014, France

Location

CHU Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anne TOURNADRE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

March 15, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)