Evaluation of Peripheral Neutrophils in Antisynthetase Syndrome (NEUTROSAS)

Evaluation of Peripheral Neutrophils in Patients With 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.

Study Overview

• Status: Completed
• Conditions: Antisynthetase Syndrome

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Vandœuvre-lès-Nancy, France
    • CHU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with antisynthetase syndrome

Description

Inclusion Criteria:

• Patients with antisyntheatse syndrome according to Solomon criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with antisynthetase syndrome

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Myositis
• Other Study ID Numbers: 2022PI209

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