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NCT Number: NCT05592574

IL17 Rate and Spondyloarthritis

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.

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Key information

Conditions

Spondylarthritis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylitis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

Other

Blood samples required to performe IL-17 Dosage

Primary outcomes

  1. to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment.

    Time frame: 18 months

    rate of IL17

Secondary outcomes

  1. predictive value of IL17 rate

    Time frame: 18 months

    to show the predictive character of this expression on the therapeutic response at three months after the implementation of a biological treatment. Response will be evaluated by BASDAI50

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara SEITZ-POLSKI

CONTACT

[email protected]

+33492035990

Christian ROUX

CONTACT

[email protected]

+33492035491

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2041
Study completion
2041
First posted
Oct 24, 2022
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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