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NCT Number: NCT05984394

Evaluation of Antigen-specific T Cells 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bernard Bonnotte, Dijon, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT

Diagnostic Test

BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT

Primary outcomes

  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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Decker, MD

CONTACT

[email protected]

+33383157240

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Evaluation of Antigen-specific Th1 and T17 Cells, ILC and MAIT in Patients With Antisynthetase Syndrome and Interstitial Lung Disease

Acronym: CYTILDASS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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