IL17 Rate and Spondyloarthritis
ConditionSpondylarthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorCentre Hospitalier Universitaire de Nice
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
No predominant axial manifestation,
Having received a previous biological treatment
Patients presenting contraindication to the implementation of these treatments.
Trial population
Spondyloarthritis recruited during rheumatology consultations in rheumatology department of CHU of NICE
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood sample
Other interventionBlood samples required to performe IL-17 Dosage
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Spondyloarthritis without biological treatment and in failure of 2 NSAIDS1 intervention
Trial outcomes
Primary outcomes
1
to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment.
rate of IL17
Time frame
18 monthsSecondary outcomes
1
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
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov