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NCT05592574Recruiting

IL17 Rate and Spondyloarthritis

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

Source: ClinicalTrials.gov · Last updated 24 Oct 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
18 Oct 2022
Start date
1 Feb 2021
Primary completion date
31 Jan 2041
Lead sponsor
Centre Hospitalier Universitaire de Nice
NCT number
NCT05592574

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 1 Feb 2021 to the primary completion date, 31 Jan 2041
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Having received a previous biological treatment

Other

  • No predominant axial manifestation,
  • Patients presenting contraindication to the implementation of these treatments.

Who the study is looking for

  • 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,

Age in the registry: 18 years to 90 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Nice
Coordinator of this site? Confirm its status
NiceFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.