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

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood sample Truculture: 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 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.

Eligibility

Primary outcome measure(s)

• Whole Blood Oxylipin Response (WBOR) — 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 — 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.

Trial sites (3)

More University Hospital, Clermont-Ferrand trials in France

Other trials for the same condition