IL17 Rate and Spondyloarthritis

NCT ID: NCT05592574

Last Updated: 2022-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2041-01-31

Brief Summary

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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

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Conditions

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Spondylarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spondyloarthritis without biological treatment and in failure of 2 NSAIDS

Blood sample

Intervention Type OTHER

Blood samples required to performe IL-17 Dosage

Interventions

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Blood sample

Blood samples required to performe IL-17 Dosage

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de NICE

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christian ROUX

Role: CONTACT

+33492035491

Barbara SEITZ-POLSKI

Role: CONTACT

+33492035990

Facility Contacts

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Christian ROUX, Md, PhD

Role: primary

+33492035491

Barbara SEITZ-POLSKI, MD, PhD

Role: backup

+33492035990

Other Identifiers

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22Rhumato02

Identifier Type: -

Identifier Source: org_study_id

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