Calprotectine in Spondyloarthritis

NCT ID: NCT05555433

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-15

Study Completion Date

2024-08-15

Brief Summary

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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

Detailed Description

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Conditions

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Spondylarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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active spondyloarthritis

subjects with active spondyloarthritis with a BASDAI greater than 4

NO INTERVENTION

Intervention Type OTHER

no intervention

remission spondyloarthritis

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

NO INTERVENTION

Intervention Type OTHER

no intervention

controls without spondyloarthritis

controls without spondyloarthritis or other chronic inflammatory rheumatism and without fibromyalgia

NO INTERVENTION

Intervention Type OTHER

no intervention

fibromyalgia

subjects with fibromyalgia

NO INTERVENTION

Intervention Type OTHER

no intervention

Interventions

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NO INTERVENTION

no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nice University Hospital

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christian ROUX, PUPH

Role: CONTACT

33492035491

Jeremy GENOVESE

Role: CONTACT

33492035491

Facility Contacts

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Christian ROUX

Role: primary

Jeremy GENOVESE

Role: backup

Other Identifiers

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22Rhumato01

Identifier Type: -

Identifier Source: org_study_id

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