IL17 Rate and Spondyloarthritis

Spondylarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05592574
• Other study ID #: 22Rhumato02
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: January 31, 2041

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Christian ROUX
• Phone: +33492035491
• Email: roux.c2[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2041
• Est. primary completion date: January 31, 2041
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylitis

Intervention

Other:
• Blood sample
Blood samples required to performe IL-17 Dosage

Locations

Country	Name	City	State
France	CHU de NICE	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment.	rate of IL17	18 months
Secondary	predictive value of IL17 rate	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	18 months