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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
View:

• 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,

Locations
Other Locations
France
CHU de NICE
RECRUITING
Nice
Contact Information
Primary
Christian ROUX
roux.c2@chu-nice.fr
+33492035491
Backup
Barbara SEITZ-POLSKI
seitz-polski.b@chu-nice.fr
+33492035990
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2041-01-31
Participants
Target number of participants: 50
Treatments
Spondyloarthritis without biological treatment and in failure of 2 NSAIDS
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov