Antisynthetase SyndromeCYTILDASSNCT05984394
Evaluation of Antigen-specific T Cells in Patients With Antisynthetase Syndrome and Interstitial Lung Disease
An observational study of Antisynthetase Syndrome, run by Central Hospital, Nancy, France at 6 sites in France.
Trial summary
Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. Intesrtitial lung disease (ILD) is a leading cause of mortality in antisynthetase syndrome. 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?
- BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT
- How many people
- 24 participants
- Where
- 6 sitesFrance
- Study dates
- 26 Aug 2024to 31 Oct 2025
- 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 AS and ILD
Who may be able to join
- Patient with new diagnosis of AS with ILD
Who cannot join
- Patient with ILD differential diagnosis
- Corticosteroid treatment, immunosuppresive or immunomodulatory drugs in the past 3 months before diagnosis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Bernard Bonnotte
Dijon
Bernard Bonnotte, PhD
- Recruiting
Julien Campagne
Metz
Julien Campagne, MD
- Recruiting
Paul Decker
Nancy
Paul Decker, +33383157240, p.decker@chru-nancy.fr
- Not yet recruiting
Olivier Benveniste
Paris
Oivier Benveniste, PhD
- Recruiting
Loïs Bolko
Reims
Loïs Bolko, MD
- Recruiting
Alain Meyer
Strasbourg
Alain Meyer, PhD
About this study
Official title: Evaluation of Antigen-specific Th1 and T17 Cells, ILC and MAIT in Patients With Antisynthetase Syndrome and Interstitial Lung Disease
Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. Intesrtitial lung disease (ILD) is a leading cause of mortality in antisynthetase syndrome. Recently, antigen-specific IFN-γ+ CD4+ T cells have been identified in bronchoalveolar fluid (BAL) of patients with antisynthetase syndrome and ILD. Elevated levels of IL1β, IL12, IL18, TNFα, IL17A, IL22 have also been detected in peripheral blood of AS patients, especially those with progressive ILD. Implication of innate lymphoid cells (ILC) and mucosal-associated invariant T cells (MAIT) have not yet been studied in patients with AS. Targeted therapies against Th1 and Th17 cells may represent a promising treatment in patients AS patients with ILD.
Investigators suppose that antigen-specific Th1 and Th17 cells, ILC and MAIT at ILD diagnosis are associated with ILD severity at diagnosis and could predict treatment response at 6 months.
The main objective is to study the correlation between BAL antigen-specific Th1 and Th17 cells at ILD diagnosis and clinical evolution after 6 months of treatment according to initial ILD severity.
- Conditions
- Antisynthetase Syndrome
- Being tested
- BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT
- Medical subject headings
- Antisynthetase syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAL antigen-specific Th1 cells and Th17 cells, ILC and MAITDiagnostic test
BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT
| Study group | Role | What they receive |
|---|---|---|
| AS patients with ILD | New diagnosis of patients with AS syndrome and ILD Receives: Diagnostic Test: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
BAL antigen-specific Th1 and Th17 cells
BAL antigen-specific Th1 and Th17 cells percentages among BAL total CD4+ T cells
Measured: baseline (J0)
FVC relative change
Relative change of FVC percentage
Measured: within 6 months after diagnosis
Secondary outcomes (4)
BAL antigen-specific Th1 and Th17 cells
BAL antigen-specific Th1 and Th17 cells percentages among total BAL CD4+ T cells
Measured: baseline (J0)
FVC
FVC percentage at ILD diagnosis
Measured: baseline (J0)
FVC absolute change
Absolute change of FVC percentage
Measured: within 6 months after diagnosis
Global activity
MDAAT score
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 posted9 Aug 2023
- Study start26 Aug 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
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
- Prospective
- Enrolment
- 24 participants (estimated)
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
- NCT05984394
- Sponsor's protocol ID
- 2023-A00804-41
- Acronym
- CYTILDASS
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2023
- Last updated
- 27 Aug 2024
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antigen-specific Th1 and T17 Cells, ILC and MAIT in Patients With Antisynthetase Syndrome and Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05984394
- Acronym / sponsor ID
- CYTILDASS / 2023-A00804-41
- Conditions
- Antisynthetase Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 9 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 (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. Intesrtitial lung disease (ILD) is a leading cause of mortality in antisynthetase syndrome. Recently, antigen-specific IFN-γ+ CD4+ T cells have been identified in bronchoalveolar fluid (BAL) of patients with antisynthetase syndrome and ILD. Elevated levels of IL1β, IL12, IL18, TNFα, IL17A, IL22 have also been detected in peripheral blood of AS patients, especially those with progressive ILD. Implication of innate lymphoid cells (ILC) and mucosal-associated invariant T cells (MAIT) have not yet been studied in patients with AS. Targeted therapies against Th1 and Th17 cells may represent a promising treatment in patients AS patients with ILD.
Investigators suppose that antigen-specific Th1 and Th17 cells, ILC and MAIT at ILD diagnosis are associated with ILD severity at diagnosis and could predict treatment response at 6 months.
The main objective is to study the correlation between BAL antigen-specific Th1 and Th17 cells at ILD diagnosis and clinical evolution after 6 months of treatment according to initial ILD severity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AS patients with ILD | – | Diagnostic Test: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAITNew diagnosis of patients with AS syndrome and ILD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with AS and ILD
Key inclusion criteria (1 listed)
- Patient with new diagnosis of AS with ILD
Key exclusion criteria (2 listed)
- Patient with ILD differential diagnosis
- Corticosteroid treatment, immunosuppresive or immunomodulatory drugs in the past 3 months before diagnosis
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 |
|---|---|---|
| BAL antigen-specific Th1 cells and Th17 cells, ILC and MAITBAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT | Diagnostic test | AS patients with ILD |
Primary outcome
BAL antigen-specific Th1 and Th17 cells
Time frame: baseline (J0)
BAL antigen-specific Th1 and Th17 cells percentages among BAL total CD4+ T cells
FVC relative change
Time frame: within 6 months after diagnosis
Relative change of FVC percentage
4 secondary outcomes
BAL antigen-specific Th1 and Th17 cells
Time frame: baseline (J0)
FVC
Time frame: baseline (J0)
FVC absolute change
Time frame: within 6 months after diagnosis
Global activity
Time frame: baseline (J0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Paul Decker, MD principal investigator
Central Hospital, Nancy, France
6 sites 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 6 sites 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 2 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Decker, MD (+33383157240, p.decker@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BAL antigen-specific Th1 and Th17 cells (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 27 Aug 2024.