SpondylarthritisCalprotectineNCT05555433
Calprotectine in Spondyloarthritis
An observational study of Spondylarthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
To date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylarthritis
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 15 Aug 2022to 15 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary clinic care, rheumatology patients at the CHU de NICE
Who may be able to join
- Patients in the active line of the rheumatology department with one of the following criteria:
- active spondyloarthritis (BASDAI >4), or spondyloarthritis in low activity (BASDAI<4), or fibromyalgia without associated inflammatory rheumatism, or healthy subjects (without inflammatory rheumatism and without fibromyalgia. Patients who have not objected to the use of their samples
Who cannot join
- Minor patient Subject not affiliated to the social security system Subject deprived of liberty Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nice University Hospital
Nice, 06000
Christian ROUX, roux.c2@chu-nice.fr
Jeremy GENOVESE, genovese.j@chu-nice.fr
About this study
Official title: Study of the Interest of Serum Calprotectin Determination in the Diagnosis of Spondyloarthritis and to Diferenciate With Fibromyalgia
To date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. A growing interest in this biomarker is emerging in rheumatology, several publications have focused on its interest in rheumatoid arthritis, highlighting an association between serum calprotectin levels and disease activity. In spondyloarthritis, a few studies seem to show that it could be a marker of disease activity. Although a 2012 study found no difference in serum calprotectin levels between subjects with spondyloarthritis and controls. Still others have shown that it could be a predictive factor of radiological evolution in the same disease key. These data support, despite the questionable results of the Klingberg study, the value of this dosage in spondyloarthritis. The objective of this work is to show that this assay could be useful to differentiate spondyloarthritis from other pathologies with similar clinical presentation such as fibromyalgia. Difficulties classically encountered in common practice in rheumatology
- Conditions
- Spondylarthritis
- Being tested
- NO INTERVENTION
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO INTERVENTIONOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| active spondyloarthritis | subjects with active spondyloarthritis with a BASDAI greater than 4 Receives: Other: NO INTERVENTION | |
| remission spondyloarthritis | subjects presenting with a remission spondyloarthritis defined by a BASDAI less than 4 Receives: Other: NO INTERVENTION | |
| controls without spondyloarthritis | controls without spondyloarthritis or other chronic inflammatory rheumatism and without fibromyalgia Receives: Other: NO INTERVENTION | |
| fibromyalgia | subjects with fibromyalgia Receives: Other: NO INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
calprotectine rate
blood test
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start15 Aug 2022
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Aug 2024 (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
- 190 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
- NCT05555433
- Sponsor's protocol ID
- 22Rhumato01
- Acronym
- Calprotectine
- Status last verified
- May 2024
- First submitted
- 22 Sep 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Interest of Serum Calprotectin Determination in the Diagnosis of Spondyloarthritis and to Diferenciate With Fibromyalgia
- ClinicalTrials.gov ID
- NCT05555433
- Acronym / sponsor ID
- Calprotectine / 22Rhumato01
- Conditions
- Spondylarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 26 Sep 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.
To date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. A growing interest in this biomarker is emerging in rheumatology, several publications have focused on its interest in rheumatoid arthritis, highlighting an association between serum calprotectin levels and disease activity. In spondyloarthritis, a few studies seem to show that it could be a marker of disease activity. Although a 2012 study found no difference in serum calprotectin levels between subjects with spondyloarthritis and controls. Still others have shown that it could be a predictive factor of radiological evolution in the same disease key. These data support, despite the questionable results of the Klingberg study, the value of this dosage in spondyloarthritis. The objective of this work is to show that this assay could be useful to differentiate spondyloarthritis from other pathologies with similar clinical presentation such as fibromyalgia. Difficulties classically encountered in common practice in rheumatology
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active spondyloarthritis | – | Other: NO INTERVENTIONsubjects with active spondyloarthritis with a BASDAI greater than 4 |
| remission spondyloarthritis | – | Other: NO INTERVENTIONsubjects presenting with a remission spondyloarthritis defined by a BASDAI less than 4 |
| controls without spondyloarthritis | – | Other: NO INTERVENTIONcontrols without spondyloarthritis or other chronic inflammatory rheumatism and without fibromyalgia |
| fibromyalgia | – | Other: NO INTERVENTIONsubjects with fibromyalgia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary clinic care, rheumatology patients at the CHU de NICE
Key inclusion criteria (2 listed)
- Patients in the active line of the rheumatology department with one of the following criteria:
- active spondyloarthritis (BASDAI >4), or spondyloarthritis in low activity (BASDAI<4), or fibromyalgia without associated inflammatory rheumatism, or healthy subjects (without inflammatory rheumatism and without fibromyalgia. Patients who have not objected to the use of their samples
Key exclusion criteria (1 listed)
- Minor patient Subject not affiliated to the social security system Subject deprived of liberty Patient under guardianship or curatorship
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 |
|---|---|---|
| NO INTERVENTIONno intervention | Other | active spondyloarthritis, controls without spondyloarthritis, fibromyalgia, remission spondyloarthritis |
Primary outcome
calprotectine rate
Time frame: 5 months
blood test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian ROUX, PUPH (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?
calprotectine rate (time frame: 5 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 17 May 2024.