Seric Calprotectine in Spondyloarthritis

NCT ID: NCT03818958

Last Updated: 2019-01-28

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

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-15

Study Completion Date

2018-01-15

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

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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active spondyloarthritis

subjects with active spondyloarthritis with a BASDAI greater than 4

blood sampling

Intervention Type OTHER

blood sampling

remission spondyloarthritis

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

blood sampling

Intervention Type OTHER

blood sampling

controls without spondyloarthritis

controls without spondyloarthritis or other chronic inflammatory rheumatism and without fibromyalgia

blood sampling

Intervention Type OTHER

blood sampling

fibromyalgia

subjects with fibromyalgia

blood sampling

Intervention Type OTHER

blood sampling

Interventions

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blood sampling

blood sampling

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

Yes

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 Hospital

Nice, , France

Site Status

Countries

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France

Other Identifiers

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17-COLL-04

Identifier Type: -

Identifier Source: org_study_id

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