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

NCT05984394 | Recruiting

• 1 other identifier: 2023-A00804-41
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (2)

• BAL antigen-specific Th1 and Th17 cells

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

  baseline (J0)

• FVC relative change

  Relative change of FVC percentage

  within 6 months after diagnosis

Secondary Outcomes (4)

• BAL antigen-specific Th1 and Th17 cells

  baseline (J0)

• FVC

  baseline (J0)

• FVC absolute change

  within 6 months after diagnosis

• Global activity

  baseline (J0)

Other Outcomes (2)

• BAL ILC

  baseline (J0)

• BAL MAIT

  baseline (J0)

Study Arms (1)

AS patients with ILD

New diagnosis of patients with AS syndrome and ILD

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 DIAGNOSTIC_TEST

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

AS patients with ILD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with AS and ILD

You may qualify if:

• Patient with new diagnosis of AS with ILD

You may not qualify if:

• Patient with ILD differential diagnosis
• Corticosteroid treatment, immunosuppresive or immunomodulatory drugs in the past 3 months before diagnosis

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (6)

Bernard Bonnotte

Dijon, France

RECRUITING

Julien Campagne

Metz, France

RECRUITING

Paul Decker

Nancy, France

RECRUITING

Olivier Benveniste

Paris, France

NOT YET RECRUITING

Loïs Bolko

Reims, France

RECRUITING

Alain Meyer

Strasbourg, France

RECRUITING

MeSH Terms

Conditions

Antisynthetase syndrome

Study Officials

• Paul Decker, MD

  CHU NANCY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Decker, MD

CONTACT

+33383157240; p.decker@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: August 26, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)