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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with new diagnosis of AS with ILD

Disqualifiers

Patient with ILD differential diagnosis

Corticosteroid treatment, immunosuppresive or immunomodulatory drugs in the past 3 months before diagnosis

Trial population

Patients with AS and ILD

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Diagnostic test

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

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: AS patients with ILD1 intervention

Trial outcomes

Primary outcomes

1

BAL antigen-specific Th1 and Th17 cells

BAL antigen-specific Th1 and Th17 cells percentages among BAL total CD4+ T cells

Time frame
baseline (J0)
2

FVC relative change

Relative change of FVC percentage

Time frame
within 6 months after diagnosis

Secondary outcomes

1

BAL antigen-specific Th1 and Th17 cells

BAL antigen-specific Th1 and Th17 cells percentages among total BAL CD4+ T cells

Time frame
baseline (J0)
2

FVC

FVC percentage at ILD diagnosis

Time frame
baseline (J0)
3

FVC absolute change

Absolute change of FVC percentage

Time frame
within 6 months after diagnosis
4

Global activity

MDAAT score

Time frame
baseline (J0)

Other outcomes

1

BAL ILC

BAL ILC percentage among total BAL lymphoid cells

Time frame
baseline (J0)
2

BAL MAIT

BAL MAIT percentage among total BAL T cells

Time frame
baseline (J0)

Sponsors and contacts

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