IL17 Rate and Spondyloarthritis

NCT05592574 | Recruiting

• 1 other identifier: 22Rhumato02
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondylarthritis

Outcome Measures

Primary Outcomes (1)

• to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment.

  rate of IL17

  18 months

Secondary Outcomes (1)

• predictive value of IL17 rate

  18 months

Study Arms (1)

Spondyloarthritis without biological treatment and in failure of 2 NSAIDS

Other: Blood sample

Interventions

Blood sample OTHER

Blood samples required to performe IL-17 Dosage

Spondyloarthritis without biological treatment and in failure of 2 NSAIDS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Spondyloarthritis recruited during rheumatology consultations in rheumatology department of CHU of NICE

You may qualify if:

• 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,

You may not qualify if:

• No predominant axial manifestation,
• Having received a previous biological treatment
• Patients presenting contraindication to the implementation of these treatments.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, 06003, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bood samples

MeSH Terms

Conditions

Spondylarthritis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Christian ROUX

CONTACT

+33492035491; roux.c2@chu-nice.fr

Barbara SEITZ-POLSKI

CONTACT

+33492035990; seitz-polski.b@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 24, 2022
• Study Start: February 1, 2021
• Primary Completion (Estimated): January 31, 2041
• Study Completion (Estimated): January 31, 2041
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)