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

University Hospital, Clermont-Ferrand

Status: Not yet enrolling

Conditions: Rheumatoid Arthritis

Treatments: Other: Blood sample Truculture

Study type: Interventional

Funder types: Other

Identifiers

NCT06880146

RBHP 2024 TOURNADRE

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cohort

Other group

Description:

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

Treatment:

Other: Blood sample Truculture