Evaluation of Peripheral Neutrophils in Antisynthetase Syndrome

Completed

• Conditions: Antisynthetase Syndrome

• Registration Number: NCT05691725
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Study Start: 2023-02-01
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with antisyntheatse syndrome according to Solomon criteria

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Muscular severity	at diagnosis (Day 0)	CPK values (U/L) in patients muscle involvement
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 DLCO values in patients with ILD

Trial Locations

Locations (1)

CHU Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France