Evaluation of Peripheral Neutrophils in Antisynthetase Syndrome

Evaluation of Peripheral Neutrophils in Patients With Antisynthetase Syndrome

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05691725

Acronym

NEUTROSAS

Enrollment

Registered

2023-01-20

Start date

2023-02-01

Completion date

2023-04-01

Last updated

2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antisynthetase Syndrome

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Patients with antisyntheatse syndrome according to Solomon criteria

Design outcomes

Primary

Measure	Time frame	Description
Number of circulating neutrophils	at diagnosis (Day 0)	circulating neutrophils values (number of cells/mm3)
Global severity	at diagnosis (Day 0)	composite criteria of global severity: severe interstitial lung disease (ILD) and/or severe muscular disease

Secondary

Measure	Time frame	Description
Circulating neutrophils change over time	at 6 months of follow-up	circulating neutrophils values (number of cells/mm3)
ILD severity	at diagnosis (Day 0)	%predicted FVC values in patients with ILD
Muscular severity	at diagnosis (Day 0)	manual muscle testing (MMT) grading in patients muscle involvement

Countries

France

Outcome results