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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT
Diagnostic testBAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT
Treatment groups
Trial outcomes
Primary outcomes
BAL antigen-specific Th1 and Th17 cells
BAL antigen-specific Th1 and Th17 cells percentages among BAL total CD4+ T cells
FVC relative change
Relative change of FVC percentage
Secondary outcomes
BAL antigen-specific Th1 and Th17 cells
BAL antigen-specific Th1 and Th17 cells percentages among total BAL CD4+ T cells
FVC
FVC percentage at ILD diagnosis
FVC absolute change
Absolute change of FVC percentage
Global activity
MDAAT score
Other outcomes
BAL ILC
BAL ILC percentage among total BAL lymphoid cells
BAL MAIT
BAL MAIT percentage among total BAL T cells
Sponsors and contacts
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