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

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

Inclusion Criteria3

  • Patients with spondyloarthritis meeting the ASAS criteria
  • Patients who were to benefit from the implementation of a biological treatment after failure of at least two NSAIDs.
  • Patients having an active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) higher than four,

Exclusion Criteria3

  • No predominant axial manifestation,
  • Having received a previous biological treatment
  • Patients presenting contraindication to the implementation of these treatments.

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Interventions

OTHERBlood sample

Blood samples required to performe IL-17 Dosage


Locations(1)

CHU de NICE

Nice, France

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NCT05592574


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