NCT05592574Recruiting
IL17 Rate and Spondyloarthritis
Feasibility of an Il-17a Assay and Impact on Therapeutic Response in Patients With Active Axial Spondyloarthritis
Source: ClinicalTrials.gov · Last updated 24 Oct 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 18 Oct 2022
- Start date
- 1 Feb 2021
- Primary completion date
- 31 Jan 2041
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT05592574
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Feb 2021 to the primary completion date, 31 Jan 2041
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having received a previous biological treatment
Other
- No predominant axial manifestation,
- Patients presenting contraindication to the implementation of these treatments.
Who the study is looking for
- 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,
Age in the registry: 18 years to 90 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.