Calprotectine in Spondyloarthritis

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Recruiting
CT.gov ID
NCT05555433
Collaborator
(none)
190
1
24
7.9

Study Details

Study Description

Brief 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. 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

Condition or Disease Intervention/Treatment Phase
  • Other: NO INTERVENTION

Study Design

Study Type:
Observational
Anticipated Enrollment :
190 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of the Interest of Serum Calprotectin Determination in the Diagnosis of Spondyloarthritis and to Diferenciate With Fibromyalgia
Actual Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Aug 15, 2024
Anticipated Study Completion Date :
Aug 15, 2024

Arms and Interventions

Arm Intervention/Treatment
active spondyloarthritis

subjects with active spondyloarthritis with a BASDAI greater than 4

Other: NO INTERVENTION
no intervention

remission spondyloarthritis

subjects presenting with a remission spondyloarthritis defined by a BASDAI less than 4

Other: NO INTERVENTION
no intervention

controls without spondyloarthritis

controls without spondyloarthritis or other chronic inflammatory rheumatism and without fibromyalgia

Other: NO INTERVENTION
no intervention

fibromyalgia

subjects with fibromyalgia

Other: NO INTERVENTION
no intervention

Outcome Measures

Primary Outcome Measures

  1. calprotectine rate [5 months]

    blood test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nice University Hospital Nice France 06000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT05555433
Other Study ID Numbers:
  • 22Rhumato01
First Posted:
Sep 26, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2022