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Evaluation of Antigen-specific T Cells in Patients With Antisynthetase Syndrome and Interstitial Lung Disease (CYTILDASS)

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ClinicalTrials.gov Identifier: NCT05984394
Recruitment Status : Not yet recruiting
First Posted : August 9, 2023
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
Paul DECKER, MD, Central Hospital, Nancy, France

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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.


Condition or disease Intervention/treatment
Antisynthetase Syndrome Diagnostic Test: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT

Study Design
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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Antigen-specific Th1 and T17 Cells, ILC and MAIT in Patients With Antisynthetase Syndrome and Interstitial Lung Disease
Estimated Study Start Date : October 31, 2023
Estimated Primary Completion Date : October 31, 2025
Estimated Study Completion Date : October 31, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
AS patients with ILD
New diagnosis of patients with AS syndrome and ILD
 Diagnostic Test: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT
BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. FVC relative change [ Time Frame: within 6 months after diagnosis ]
    Relative change of FVC percentage


Secondary Outcome Measures :
  1. BAL antigen-specific Th1 and Th17 cells [ Time Frame: baseline (J0) ]
    BAL antigen-specific Th1 and Th17 cells percentages among total BAL CD4+ T cells

  2. FVC [ Time Frame: baseline (J0) ]
    FVC percentage at ILD diagnosis

  3. FVC absolute change [ Time Frame: within 6 months after diagnosis ]
    Absolute change of FVC percentage

  4. Global activity [ Time Frame: baseline (J0) ]
    MDAAT score


Other Outcome Measures:
  1. BAL ILC [ Time Frame: baseline (J0) ]
    BAL ILC percentage among total BAL lymphoid cells

  2. BAL MAIT [ Time Frame: baseline (J0) ]
    BAL MAIT percentage among total BAL T cells


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with AS and ILD
Criteria

Inclusion Criteria:

  • Patient with new diagnosis of AS with ILD

Exclusion Criteria:

  • Patient with ILD differential diagnosis
  • Corticosteroid treatment, immunosuppresive or immunomodulatory drugs in the past 3 months before diagnosis
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05984394


Contacts
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Contact: Paul Decker, MD +33383157240 p.decker@chru-nancy.fr

Locations
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France
Bernard Bonnotte
Dijon, France
Contact: Bernard Bonnotte, PhD         
Julien Campagne
Metz, France
Contact: Julien Campagne, MD         
Paul Decker
Nancy, France
Contact: Paul Decker    +33383157240    p.decker@chru-nancy.fr   
Olivier Benveniste
Paris, France
Contact: Oivier Benveniste, PhD         
Loïs Bolko
Reims, France
Contact: Loïs Bolko, MD         
Alain Meyer
Strasbourg, France
Contact: Alain Meyer, PhD         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Paul Decker, MD CHU Nancy
More Information
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Responsible Party: Paul DECKER, MD, Principal Investigator, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT05984394    
Other Study ID Numbers: 2023-A00804-41
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myositis
Lung Diseases
Lung Diseases, Interstitial
Syndrome
Disease
Pathologic Processes
 Respiratory Tract Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases