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OpenTrials
Completed

NCT Number: NCT03818958

Seric Calprotectine in Spondyloarthritis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nice Hospital

Nice, 06000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

blood sampling

Primary outcomes

  1. calprotectine rate

    Time frame: 5 months

    blood test

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: Calprotect

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 28, 2019
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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