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IL17 Rate and Spondyloarthritis

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05592574
Enrollment
50
Registered
2022-10-24
Start date
2021-02-01
Completion date
2041-01-31
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylarthritis

Brief 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.

Interventions

OTHERBlood sample

Blood samples required to performe IL-17 Dosage

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment.18 monthsrate of IL17

Secondary

MeasureTime frameDescription
predictive value of IL17 rate18 monthsto 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

Countries

France

Contacts

Primary ContactChristian ROUX
roux.c2@chu-nice.fr+33492035491
Backup ContactBarbara SEITZ-POLSKI
seitz-polski.b@chu-nice.fr+33492035990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026