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IL17 Rate and Spondyloarthritis

C

Centre Hospitalier Universitaire de Nice

Status

Enrolling

Conditions

Spondylarthritis

Treatments

Other: Blood sample

Study type

Observational

Funder types

Other

Identifiers

NCT05592574
22Rhumato02

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • 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 criteria

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

Trial design

50 participants in 1 patient group

Spondyloarthritis without biological treatment and in failure of 2 NSAIDS
Treatment:
Other: Blood sample

Trial contacts and locations

1

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Central trial contact

Barbara SEITZ-POLSKI; Christian ROUX

Data sourced from clinicaltrials.gov

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