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Recruiting NCT05984394

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

— Observational Antisynthetase Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT.
Who it may be relevant to
Registry conditions: Antisynthetase Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Diagnostic test BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT
    BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT

Primary outcome measures

  • BAL antigen-specific Th1 and Th17 cells [Time frame: baseline (J0)]
  • FVC relative change [Time frame: within 6 months after diagnosis]
Secondary outcome measures (4)
  • 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)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 6 centers
  • Bernard Bonnotte — Dijon
  • Julien Campagne — Metz
  • Paul Decker — Nancy
  • Olivier Benveniste — Paris
  • Loïs Bolko — Reims
  • Alain Meyer — Strasbourg

Identifiers

NCT: NCT05984394 · 2023-A00804-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗