Seric Calprotectine in Spondyloarthritis (Calprotect)

January 25, 2019 updated by: Centre Hospitalier Universitaire de Nice

Study of the Interest of Serum Calprotectin Determination in the Diagnosis of Spondyloarthritis and to Diferenciate With Fibromyalgia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Nice hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary clinic care, rheumatology patients at the CHU de NICE

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
active spondyloarthritis
subjects with active spondyloarthritis with a BASDAI greater than 4
Other: blood sampling
blood sampling
remission spondyloarthritis
subjects presenting with a remission spondyloarthritis defined by a BASDAI less than 4
Other: blood sampling
blood sampling
controls without spondyloarthritis
controls without spondyloarthritis or other chronic inflammatory rheumatism and without fibromyalgia
Other: blood sampling
blood sampling
fibromyalgia
subjects with fibromyalgia
Other: blood sampling
blood sampling

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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2017

Primary Completion (ACTUAL)

January 15, 2018

Study Completion (ACTUAL)

January 15, 2018

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

January 25, 2019

First Posted (ACTUAL)

January 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-COLL-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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