IL17 Rate and Spondyloarthritis

Recruiting

• Conditions: Spondylarthritis
• Interventions: Other: Blood sample

• Registration Number: NCT05592574
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-21
• Last Update Submitted: 2022-10-21
• Study First Posted: 2022-10-24
• Last Update Posted: 2022-10-24
• Primary Completion: 2041-01-31
• Study Completion: 2041-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spondyloarthritis without biological treatment and in failure of 2 NSAIDS	Blood sample	-

Primary Outcome Measures

Name	Time	Method
to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment.	18 months	rate of IL17

Secondary Outcome Measures

Name	Time	Method
predictive value of IL17 rate	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

Trial Locations

Locations (1)

CHU de NICE; 🇫🇷 Nice, France