Calprotectine in Spondyloarthritis

NCT05555433 | Recruiting

• 1 other identifier: 22Rhumato01
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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

Conditions

Spondylarthritis

Outcome Measures

Primary Outcomes (1)

• calprotectine rate

  blood test

  5 months

Study Arms (4)

active spondyloarthritis

subjects with active spondyloarthritis with a BASDAI greater than 4

Other: NO INTERVENTION

remission spondyloarthritis

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

Other: NO INTERVENTION

controls without spondyloarthritis

controls without spondyloarthritis or other chronic inflammatory rheumatism and without fibromyalgia

Other: NO INTERVENTION

fibromyalgia

subjects with fibromyalgia

Other: NO INTERVENTION

Interventions

NO INTERVENTION OTHER

no intervention

active spondyloarthritis; controls without spondyloarthritis; fibromyalgia; remission spondyloarthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary clinic care, rheumatology patients at the CHU de NICE

You may qualify if:

• 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

You may not qualify if:

• Minor patient Subject not affiliated to the social security system Subject deprived of liberty Patient under guardianship or curatorship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, 06000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Central Study Contacts

Christian ROUX, PUPH

CONTACT

33492035491; roux.c2@chu-nice.fr

Jeremy GENOVESE

CONTACT

33492035491; genovese.j@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 26, 2022
• Study Start: August 15, 2022
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)