NCT05691725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

January 11, 2023

Last Update Submit

August 2, 2023

Conditions

Antisynthetase Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Circulating neutrophils change over time

    at 6 months of follow-up

  • ILD severity

    at diagnosis (Day 0)

  • ILD severity

    at diagnosis (Day 0)

  • Muscular severity

    at diagnosis (Day 0)

  • Muscular severity

    at diagnosis (Day 0)

Study Arms (1)

Patients with antisynthetase syndrome

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with antisynthetase syndrome

You may qualify if:

  • Patients with antisyntheatse syndrome according to Solomon criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nancy

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Antisynthetase syndrome

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 20, 2023

Study Start

February 1, 2023

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)