Antisynthetase SyndromeNEUTROSASNCT05691725
Evaluation of Peripheral 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 (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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antisynthetase Syndrome
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 1 Apr 2023
- 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
- Adult, Older adult
Study population: Patients with antisynthetase syndrome
Who may be able to join
- Patients with antisyntheatse syndrome according to Solomon criteria
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Antisynthetase Syndrome
- Medical subject headings
- Antisynthetase syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with antisynthetase syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of circulating neutrophils
circulating neutrophils values (number of cells/mm3)
Measured: at diagnosis (Day 0)
Global severity
composite criteria of global severity: severe interstitial lung disease (ILD) and/or severe muscular disease
Measured: at diagnosis (Day 0)
Secondary outcomes (5)
Circulating neutrophils change over time
circulating neutrophils values (number of cells/mm3)
Measured: at 6 months of follow-up
ILD severity
%predicted FVC values in patients with ILD
Measured: at diagnosis (Day 0)
ILD severity
%predicted DLCO values in patients with ILD
Measured: at diagnosis (Day 0)
Muscular severity
manual muscle testing (MMT) grading in patients muscle involvement
Measured: at diagnosis (Day 0)
Muscular severity
CPK values (U/L) in patients muscle involvement
Measured: at diagnosis (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
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
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691725
- Sponsor's protocol ID
- 2022PI209
- Acronym
- NEUTROSAS
- Status last verified
- Aug 2023
- First submitted
- 11 Jan 2023
- Last updated
- 3 Aug 2023
- 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 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peripheral Neutrophils in Patients With Antisynthetase Syndrome
- ClinicalTrials.gov ID
- NCT05691725
- Acronym / sponsor ID
- NEUTROSAS / 2022PI209
- Conditions
- Antisynthetase Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 20 Jan 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 (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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with antisynthetase syndrome | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with antisynthetase syndrome
Key inclusion criteria (1 listed)
- Patients with antisyntheatse syndrome according to Solomon criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of circulating neutrophils
Time frame: at diagnosis (Day 0)
circulating neutrophils values (number of cells/mm3)
Global severity
Time frame: at diagnosis (Day 0)
composite criteria of global severity: severe interstitial lung disease (ILD) and/or severe muscular disease
5 secondary outcomes
Circulating neutrophils change over time
Time frame: at 6 months of follow-up
ILD severity
Time frame: at diagnosis (Day 0)
ILD severity
Time frame: at diagnosis (Day 0)
Muscular severity
Time frame: at diagnosis (Day 0)
Muscular severity
Time frame: at diagnosis (Day 0)
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 3 Aug 2023.
- Individual participant dataSharing planned: No
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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
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 0 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 3 Aug 2023. 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?
Number of circulating neutrophils (time frame: at diagnosis (Day 0)). 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 3 Aug 2023.