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

NCT ID: NCT05984394

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-26
• Study Completion Date: 2025-10-31

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.

Conditions

Antisynthetase Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AS patients with ILD

New diagnosis of patients with AS syndrome and ILD

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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Paul DECKER, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Decker, MD

Role: PRINCIPAL_INVESTIGATOR

CHU NANCY

Locations

Bernard Bonnotte

Dijon, , France

Site Status: RECRUITING

Julien Campagne

Metz, , France

Site Status: RECRUITING

Paul Decker

Nancy, , France

Site Status: RECRUITING

Olivier Benveniste

Paris, , France

Site Status: NOT_YET_RECRUITING

Loïs Bolko

Reims, , France

Site Status: RECRUITING

Alain Meyer

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Paul Decker, MD

Role: CONTACT

p.decker@chru-nancy.fr

+33383157240

Facility Contacts

Bernard Bonnotte, PhD

Role: primary

Julien Campagne, MD

Role: primary

Paul Decker

Role: primary

p.decker@chru-nancy.fr

+33383157240

Oivier Benveniste, PhD

Role: primary

Loïs Bolko, MD

Role: primary

Alain Meyer, PhD

Role: primary

Other Identifiers

2023-A00804-41

Identifier Type: -

Identifier Source: org_study_id