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ClinicalTrials.gov ID

NCT06880146

Lead Sponsor

University Hospital, Clermont-FerrandOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

30Estimated

Last Update Posted

Mar 17, 2025Actual

Start Date

Mar 15, 2025Estimated

Primary Completion Date

Nov 1, 2026Estimated

Completion Date

Nov 1, 2027Estimated

Official Title

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

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.

• Rheumatoid Arthritis

• Blood sample Truculture

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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)

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, Clermont-FerrandOTHER

Collaborators

Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône AlpesUNKNOWN

Immunology department, CHU Clermont-FerrandUNKNOWN

University of SouthamptonOTHER

promo_interne_drci@chu-clermontferrand.fr+33473754963

promo_interne_drci@chu-clermontferrand.fr+33473754963