SpondylarthritisNCT05592574
IL17 Rate and Spondyloarthritis
An observational study of Spondylarthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Spondylarthritis
- What is being tested?
- Blood sample
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 31 Jan 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Spondyloarthritis recruited during rheumatology consultations in rheumatology department of CHU of NICE
Who may be able to join
- 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,
Who cannot join
- No predominant axial manifestation,
- Having received a previous biological treatment
- Patients presenting contraindication to the implementation of these treatments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de NICE
Nice, 06003
Christian ROUX, Md, PhD, +33492035491, roux.c2@chu-nice.fr
Barbara SEITZ-POLSKI, MD, PhD, +33492035990, seitz-polski.b@chu-nice.fr
About this study
Official title: Feasibility of an Il-17a Assay and Impact on Therapeutic Response in Patients With Active Axial Spondyloarthritis
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.
Read more
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
- Being tested
- Blood sample
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood samples required to performe IL-17 Dosage
| Study group | Role | What they receive |
|---|---|---|
| Spondyloarthritis without biological treatment and in failure of 2 NSAIDS | Not described Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment.
rate of IL17
Measured: 18 months
Secondary 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Feb 2021
- Primary completion31 Jan 2041 (estimated)
- Study completion31 Jan 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylarthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592574
- Sponsor's protocol ID
- 22Rhumato02
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not schedule
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Il-17a Assay and Impact on Therapeutic Response in Patients With Active Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT05592574
- Acronym / sponsor ID
- 22Rhumato02
- Conditions
- Spondylarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jan 2041 (estimated)
- Study completion
- 31 Jan 2041 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spondyloarthritis without biological treatment and in failure of 2 NSAIDS | – | Other: Blood sample |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Spondyloarthritis recruited during rheumatology consultations in rheumatology department of CHU of NICE
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (3 listed)
- No predominant axial manifestation,
- Having received a previous biological treatment
- Patients presenting contraindication to the implementation of these treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood samples required to performe IL-17 Dosage | Other | Spondyloarthritis without biological treatment and in failure of 2 NSAIDS |
Primary outcome
to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment.
Time frame: 18 months
rate of IL17
1 secondary outcome
predictive value of IL17 rate
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Individual participant dataSharing planned: No. not schedule
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylarthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian ROUX (+33492035491, roux.c2@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.