- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05555433
Calprotectine in Spondyloarthritis (Calprotectine)
Study of the Interest of Serum Calprotectin Determination in the Diagnosis of Spondyloarthritis and to Diferenciate With Fibromyalgia
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Christian ROUX, PUPH
- Phone Number: 33492035491
- Email: roux.c2@chu-nice.fr
Study Contact Backup
- Name: Jeremy GENOVESE
- Phone Number: 33492035491
- Email: genovese.j@chu-nice.fr
Study Locations
-
-
-
Nice, France, 06000
- Recruiting
- Nice University Hospital
-
Contact:
- Jeremy GENOVESE
- Email: genovese.j@chu-nice.fr
-
Principal Investigator:
- Christian Roux, PUPH
-
Sub-Investigator:
- Jeremy GENOVESE, PH
-
Sub-Investigator:
- Marina BERNARDIN, PH
-
Sub-Investigator:
- Lea EVENOR, PH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
Minor patient Subject not affiliated to the social security system Subject deprived of liberty Patient under guardianship or curatorship
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
active spondyloarthritis
subjects with active spondyloarthritis with a BASDAI greater than 4
|
no intervention
|
remission spondyloarthritis
subjects presenting with a remission spondyloarthritis defined by a BASDAI less than 4
|
no intervention
|
controls without spondyloarthritis
controls without spondyloarthritis or other chronic inflammatory rheumatism and without fibromyalgia
|
no intervention
|
fibromyalgia
subjects with fibromyalgia
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
calprotectine rate
Time Frame: 5 months
|
blood test
|
5 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22Rhumato01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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