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

Recruiting

• Conditions: Antisynthetase Syndrome
• Interventions: Diagnostic Test: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT

• Registration Number: NCT05984394
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-09
• Status Verified: 2024-08
• Study Start: 2024-08-26
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AS patients with ILD	BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT	New diagnosis of patients with AS syndrome and ILD

Primary Outcome Measures

Name	Time	Method
FVC relative change	within 6 months after diagnosis	Relative change of FVC percentage
BAL antigen-specific Th1 and Th17 cells	baseline (J0)	BAL antigen-specific Th1 and Th17 cells percentages among BAL total CD4+ T cells

Secondary Outcome Measures

Name	Time	Method
Global activity	baseline (J0)	MDAAT score
FVC	baseline (J0)	FVC percentage at ILD diagnosis
BAL antigen-specific Th1 and Th17 cells	baseline (J0)	BAL antigen-specific Th1 and Th17 cells percentages among total BAL CD4+ T cells
FVC absolute change	within 6 months after diagnosis	Absolute change of FVC percentage

Trial Locations

Locations (6)

Olivier Benveniste; 🇫🇷 Paris, France

Bernard Bonnotte; 🇫🇷 Dijon, France

Loïs Bolko; 🇫🇷 Reims, France

Alain Meyer; 🇫🇷 Strasbourg, France

Julien Campagne; 🇫🇷 Metz, France

Paul Decker; 🇫🇷 Nancy, France