Antisynthetase SyndromeNEUTROSAS2NCT05989399
Evaluation of Circulating Neutrophils in Antisynthetase Syndrome
An observational study of Antisynthetase Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Antisynthetase syndrome (ASyS) is a rare and heteregeneous overlapping connective tissue disease, characterized by myositis, interstitial lung disease (ILD), joint involvement, Raynaud's phenomenon and cutaneous manifestations ("mechanic's hands"). Over 50% of patients develop ILD, which is the leading cause of death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antisynthetase Syndrome
- What is being tested?
- circulating neutrophils
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 10 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ASyS diagnosis between January 2010 and December 2022
Who may be able to join
- Patients with ASyS diagnosis according to Connors criteria
Who cannot join
- Active infection at ASyS diagnosis
- Evolutive cancer at ASyS diagnosis
- Corticosteroid therapy initiation before circulating neutrophils evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Circulating Neutrophils in Antisynthetase Syndrome: a Multicenter Retrospective Study
Antisynthetase syndrome (ASyS) is a rare and heteregeneous overlapping connective tissue disease, characterized by myositis, interstitial lung disease (ILD), joint involvement, Raynaud's phenomenon and cutaneous manifestations ("mechanic's hands"). Over 50% of patients develop ILD, which is the leading cause of death.
The role of neutrophils - innate immune cells involved in inflammatory processes and induced in particular by cytokines of the Th17 pathway - during AS is unknown. Direct pathogenic role of neutrophils has been described during idiopathic inflammatory myopathies, with an increase of netosis correlated with disease activity and muscle damage. During ASyS, a higher number of alveolar neutrophils has been observed in patients with rapidly progressive ILD.
Read more
There are few data on the specific evaluation of circulating neutrophils in ASyS. Investigators suppose that circulating neutrophils level could represent a simple and accessible severity biomarker in patients with ASyS.
The main objective is to evaluate the diagnostic performance of the circulating neutrophils level (> 7000/mm3) at diagnosis on ASyS severity.
The secondary objectives are:
- to define a threshold for circulating neutrophils levels at diagnosis allowing to predict ASyS severity and to assess the diagnostic performance of this threshold.
- to define a threshold for the circulating neutrophils/lymphocytes ratio at diagnosis allowing to predict ASyS severity and to assess the diagnostic performance of this threshold.
- to study the correlation between the level of circulating neutrophils and ASyS severity at diagnosis of the disease.
- to study the correlation between the circulating neutrophils/lymphocytes ratio and ASyS severity at diagnosis of the disease.
- to compare the circulating neutrophils level at ASyS diagnosis and after 1 year of treatment.
- to compare the circulating neutrophils/lymphocytes ratio at ASyS diagnosis and after 1 year of treatment.
- to compare patients characteristics according to ASyS severity at diagnosis.
- to compare BAL fluid neutrophils level according to ILD severity at ASyS diagnosis in patients with ILD.
- to compare BAL fluid neutrophils/lymphocytes ratio according to ILD severity at ASyS diagnosis in patients with ILD.
- Conditions
- Antisynthetase Syndrome
- Being tested
- circulating neutrophils
- Medical subject headings
- Antisynthetase syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circulating neutrophilsDiagnostic test
evaluation of circulating neutrophils level
| Study group | Role | What they receive |
|---|---|---|
| ASyS patients | Patients with antisynthetase syndrome Receives: Diagnostic Test: circulating neutrophils |
What is being measured
The primary outcome is the main question the study is designed to answer.
circulating neutrophils level > 7000/mm3
Measured: baseline (J0)
number of patients with global severity
global severity defined as presence of severe ILD (PaO2 < 600 mmHg or rapidly progressive ILD), and/or presence of severe myositis (bedrest, or MMT8 score < 30, or MRC muscle testing < 3/5, or swallowing disorers, or dysphagia) and/or presence of myocarditis on cardiac MRI
Measured: baseline (J0)
Secondary outcomes (10)
circulating neutrophils level
Measured: baseline (J0)
circulating neutrophils/lymphocytes ratio
Measured: baseline (J0)
FVC
FVC percentage
Measured: baseline (J0)
DLCO
DLCO percentage
Measured: baseline (J0)
grade of MRC muscle testing
Measured: baseline (J0)
CK level
Measured: baseline (J0)
circulating neutrophils level
Measured: 12 months
circulating neutrophils/lymphocytes ratio
Measured: 12 months
BAL fluid neutrophils level
Measured: baseline (J0)
BAL fluid neutrophils/lymphocytes ratio
Measured: baseline (J0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2024
- Primary completion10 Jan 2026
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antisynthetase SyndromeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul DECKER, MD, Central Hospital, Nancy, France
- Investigators
- Paul Decker, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989399
- Sponsor's protocol ID
- 2023PI083
- Acronym
- NEUTROSAS2
- Status last verified
- Apr 2026
- First submitted
- 4 Aug 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Circulating Neutrophils in Antisynthetase Syndrome: a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT05989399
- Acronym / sponsor ID
- NEUTROSAS2 / 2023PI083
- Conditions
- Antisynthetase Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antisynthetase syndrome (ASyS) is a rare and heteregeneous overlapping connective tissue disease, characterized by myositis, interstitial lung disease (ILD), joint involvement, Raynaud's phenomenon and cutaneous manifestations ("mechanic's hands"). Over 50% of patients develop ILD, which is the leading cause of death.
The role of neutrophils - innate immune cells involved in inflammatory processes and induced in particular by cytokines of the Th17 pathway - during AS is unknown. Direct pathogenic role of neutrophils has been described during idiopathic inflammatory myopathies, with an increase of netosis correlated with disease activity and muscle damage. During ASyS, a higher number of alveolar neutrophils has been observed in patients with rapidly progressive ILD.
There are few data on the specific evaluation of circulating neutrophils in ASyS. Investigators suppose that circulating neutrophils level could represent a simple and accessible severity biomarker in patients with ASyS.
The main objective is to evaluate the diagnostic performance of the circulating neutrophils level (> 7000/mm3) at diagnosis on ASyS severity.
The secondary objectives are:
- to define a threshold for circulating neutrophils levels at diagnosis allowing to predict ASyS severity and to assess the diagnostic performance of this threshold.
- to define a threshold for the circulating neutrophils/lymphocytes ratio at diagnosis allowing to predict ASyS severity and to assess the diagnostic performance of this threshold.
- to study the correlation between the level of circulating neutrophils and ASyS severity at diagnosis of the disease.
- to study the correlation between the circulating neutrophils/lymphocytes ratio and ASyS severity at diagnosis of the disease.
- to compare the circulating neutrophils level at ASyS diagnosis and after 1 year of treatment.
- to compare the circulating neutrophils/lymphocytes ratio at ASyS diagnosis and after 1 year of treatment.
- to compare patients characteristics according to ASyS severity at diagnosis.
- to compare BAL fluid neutrophils level according to ILD severity at ASyS diagnosis in patients with ILD.
- to compare BAL fluid neutrophils/lymphocytes ratio according to ILD severity at ASyS diagnosis in patients with ILD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASyS patients | – | Diagnostic Test: circulating neutrophilsPatients with antisynthetase syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ASyS diagnosis between January 2010 and December 2022
Key inclusion criteria (1 listed)
- Patients with ASyS diagnosis according to Connors criteria
Key exclusion criteria (3 listed)
- Active infection at ASyS diagnosis
- Evolutive cancer at ASyS diagnosis
- Corticosteroid therapy initiation before circulating neutrophils evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| circulating neutrophilsevaluation of circulating neutrophils level | Diagnostic test | ASyS patients |
Primary outcome
circulating neutrophils level > 7000/mm3
Time frame: baseline (J0)
number of patients with global severity
Time frame: baseline (J0)
global severity defined as presence of severe ILD (PaO2 < 600 mmHg or rapidly progressive ILD), and/or presence of severe myositis (bedrest, or MMT8 score < 30, or MRC muscle testing < 3/5, or swallowing disorers, or dysphagia) and/or presence of myocarditis on cardiac MRI
10 secondary outcomes
circulating neutrophils level
Time frame: baseline (J0)
circulating neutrophils/lymphocytes ratio
Time frame: baseline (J0)
FVC
Time frame: baseline (J0)
DLCO
Time frame: baseline (J0)
grade of MRC muscle testing
Time frame: baseline (J0)
CK level
Time frame: baseline (J0)
circulating neutrophils level
Time frame: 12 months
circulating neutrophils/lymphocytes ratio
Time frame: 12 months
BAL fluid neutrophils level
Time frame: baseline (J0)
BAL fluid neutrophils/lymphocytes ratio
Time frame: baseline (J0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Antisynthetase Syndrome
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
Myositis, Active Idiopathic Inflammatory Myopathy
RecruitingPhase 2
Descartes-08 in Autoantibody Myositis
Antisynthetase Syndrome
RecruitingPhase 1
BCMA-CD19 cCAR-T for the Treatment of Refractory Inflammatory Myopathy
Inflammatory Myopathy
Recruiting
A Study on the Efficacy and Safety of JAK Inhibitors Versus Calcineurin Inhibitors as Initial Therapy for Interstitial Lung Disease Associated With Antisynthetase Syndrome
Antisynthetase Syndrome, Interstitial Lung Disease (ILD)
Active, not recruitingPhase 2/3
Add-on Intravenous Immunoglobulins in Early Myositis
Inflammatory Myopathy, Idiopathic, Dermatomyositis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Decker, MD principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antisynthetase Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circulating neutrophils level > 7000/mm3 (time frame: baseline (J0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.