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OpenTrials
Completed

NCT Number: NCT05691725

Evaluation of Peripheral Neutrophils in Antisynthetase Syndrome

Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. A pathogenic role of neutrophils was described during inflammatory myopathies, with increased netosis correlated with disease activity and muscle damage. Higher number of alveolar neutrophils was observed in patients with rapidly progressive forms of interstitial lung disease.

Peripheral neutrophils could represent a simple biomarker of severity and activity in patients with antisynthetase syndrome.

The main objective is to compare circulating neutrophils between severe and non severe patients with antisynthetase syndrome. Secondary objectives are: 1) to evaluate correlation between circulating neutrophils and organ-specific severity, 2) to compare circulating neutrophils at time of diagnosis and circulating neutrophils after 6 months of treatment in patients with antisynthetase syndrome.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nancy

Vandœuvre-lès-Nancy, France

Who can participate

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

Inclusion criteria

  • Patients with antisyntheatse syndrome according to Solomon criteria

Treatment and study plan

Primary outcomes

  1. Number of circulating neutrophils

    Time frame: at diagnosis (Day 0)

    circulating neutrophils values (number of cells/mm3)

  2. Global severity

    Time frame: at diagnosis (Day 0)

    composite criteria of global severity: severe interstitial lung disease (ILD) and/or severe muscular disease

Secondary outcomes

  1. Circulating neutrophils change over time

    Time frame: at 6 months of follow-up

    circulating neutrophils values (number of cells/mm3)

  2. ILD severity

    Time frame: at diagnosis (Day 0)

    %predicted FVC values in patients with ILD

  3. ILD severity

    Time frame: at diagnosis (Day 0)

    %predicted DLCO values in patients with ILD

  4. Muscular severity

    Time frame: at diagnosis (Day 0)

    manual muscle testing (MMT) grading in patients muscle involvement

  5. Muscular severity

    Time frame: at diagnosis (Day 0)

    CPK values (U/L) in patients muscle involvement

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Evaluation of Peripheral Neutrophils in Patients With Antisynthetase Syndrome

Acronym: NEUTROSAS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2023
Registry last updated
Aug 3, 2023

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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