RecruitingNCT05592574

IL17 Rate and Spondyloarthritis

Feasibility of an Il-17a Assay and Impact on Therapeutic Response in Patients With Active Axial Spondyloarthritis

Sponsor

Centre Hospitalier Universitaire de Nice

Enrollment

50 participants

Start Date

Feb 1, 2021

Study Type

OBSERVATIONAL

Conditions

Spondylarthritis

Summary

There are, to date, no validated biomarkers or head-to-head RCTs of biologics to guide choice of biologic agent in axSpA. While there are now two head-to-head studies of a TNF inhibitor (TNFi) vs an IL-17 inhibitor (IL-17i) in psoriatic arthritis. Recommendations refers to biological DMARDs (bDMARDs) including TNFi and IL-17i for patients with high disease activity despite the use (or intolerance/contraindication) of at least two non-steroidal anti-inflammatory drugs (NSAIDs) in axial SpA (axSpA) and in failure of a strategy including methotrexate for psoriatic arthritis. A tool to help us to decide which bDMARDs to use is necessary. In SpA, the method of determination of IL17 seems to be questionable. The determination of cytokines after stimulation of immune cells in patients with active SpA requiring a biological treatment could provide us with a tool to assist in the choice of therapy. The aim of the study was to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment. And secondly, to show the predictive character of this expression on the therapeutic response at three months after the implementation of a biological treatment.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study measures levels of the inflammatory protein IL-17 in patients with spondyloarthritis — a group of inflammatory joint diseases that cause back pain and stiffness — who are about to start a new biologic medication. The study aims to understand whether IL-17 levels can help predict which patients will respond to which type of biologic treatment. You may be eligible if: - You are between 18 and 90 years old - You have spondyloarthritis meeting internationally accepted diagnostic criteria (ASAS) - Your disease is currently active (BASDAI score above 4) - You have tried at least two NSAIDs without adequate relief - You are about to start a biologic treatment You may NOT be eligible if: - You do not have predominantly axial (spine) involvement - You have previously received a biologic treatment - You have a contraindication to the biologic treatments being studied Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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