Systemic Sclerosis and Innate T Cells

NCT04995588 | Completed

• 1 other identifier: Sclero-LTI
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

Innate T cells (ITC) are decreased in systemic sclerosis (SS) and an early lymphocyte innateness has been reported. In the other part, ITC are implicated on inflammatory process, including the IL-33/ST2 axis, which is also involved in ScS endotheliopathy. Data are however scarce and physiopathological mechanisms have not been assessed to date. The investigators hypothesize a global lymphocyte innateness in SSc, linked to a chronic ITC stimulation by innate signals leading to ITC exhaustion, and their potential role in endotheliopathy and fibroblast activation in SSc.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (5)

• Basal numeration of circulating ITC (iNKT, MAIT, γδ-T and innate CD8(+) T-cells)

  Percentage AND absolute count of iNKT, MAIT, γδ-T and innate CD8(+) T- cells in flow cytometry among total T cells in SSc patients (n=60), patients with other connective tissue disease (systemic lupus erythematosus, rheumatoid arthritis, primary Sjögren's syndrome, idiopathic inflammatory myopathies) (n=60), and in healthy subjects (n=60)

  Through study completion, an average of 1 year

• Basal expression level of Ki67 among circulating ITC (iNKT, MAIT, γδ-T and innate CD8(+) T-cells)

  Percentage of iNKT, MAIT, γδ-T and innate CD8(+) T-cells expressing Ki67 in flow cytometry in SSc patients (n=60), patients with other connective tissue disease (systemic lupus erythematosus, rheumatoid arthritis, primary Sjögren's syndrome, idiopathic inflammatory myopathies) (n=60), and in healthy subjects (n=60)

  Through study completion, an average of 1 year

• Basal expression level of PLZF AND Eomes AND T-bet AND Helios of circulating ITC (iNKT, MAIT, γδ-T and innate CD8(+) T-cells)

  Percentage of iNKT, MAIT, γδ-T and innate CD8(+) T-cells expressing PLZF, Eomes, T-bet and Helios in flow cytometry in SSc patients (n=60), patients with other connective tissue disease (systemic lupus erythematosus, rheumatoid arthritis, primary Sjögren's syndrome, idiopathic inflammatory myopathies) (n=60), and in healthy subjects (n=60)

  Through study completion, an average of 1 year

• Basal expression of perforin AND granzyme A among circulating ITC (iNKT, MAIT, γδ-T and innate CD8(+) T-cells)

  Percentage of iNKT, MAIT, γδ-T and innate CD8(+) T-cells expressing perforin and granzyme A in flow cytometry in SSc patients (n=60), patients with other connective tissue disease (systemic lupus erythematosus, rheumatoid arthritis, primary Sjögren's syndrome, idiopathic inflammatory myopathies) (n=60), and in healthy subjects (n=60)

  Through study completion, an average of 1 year

• IFN-ɣ, IL-4 and IL-17 production of iNKT, MAIT, γδ-T and innate CD8(+) T-cells in response to IL-1, IL-8, IL-12, IL-18, IL-33 and fractalkine

  Percentage of iNKT, MAIT, γδ-T and innate CD8(+) T-cells expressing IFN-ɣ AND IL-4 AND IL-17 in flow cytometry upon stimulation by various combinations of IL-1, IL-8, IL-12, IL-18, IL-33 and fractalkine in SSc patients (n=60), patients with other connective tissue disease (systemic lupus erythematosus, rheumatoid arthritis, primary Sjögren's syndrome, idiopathic inflammatory myopathies) (n=60), and in healthy subjects (n=60)

  Through study completion, an average of 1 year

Study Arms (1)

Blood test

OTHER

Unique blood test for all the participants included in the study to constitute a local biobank to assess in a grouped manner the prespecified outcomes

Other: Blood test

Interventions

Blood test OTHER

Unique blood draw of 45mL for all the participants

Blood test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SSc according to the 2013 ACR/EULAR 2013 criteria (or the 2001 Leroy's criteria for early SSc)
• Patients with others connective tissue disease:
• Systemic erythematosus lupus (SLE) according to the 2019 ACR/EULAR criteria
• Primary Sjögren syndrome (pSS) according to the 2016 ACR/EULAR criteria
• Rheumatoid arthritis according to the 2010 ACR/EULAR criteria
• Idiopathic inflammatory myopathy (IIM) according to the 2017 ACR/EULAR criteria
• Healthy subjects from general population without known autoimmune disease or connective tissue disease
• ≥18 years-old

You may not qualify if:

• Overlap syndrome (including secondary Sjögren syndrome)
• Weight \<55 kgs
• Known primary cell immunodeficiency
• Past of autologous or allogenic hematopoietic stem cell transplantation
• Solid neoplasia or malignant hemopathy in remission for less than 12 months an
• Chemotherapy and/or immune checkpoint inhibitors in the last 12 months
• Systemic retinoids
• Active infection and/or antibiotics in the last 2 weeks
• Known active chronic infection among HIV, HTLV, viral hepatitis, syphilis
• Vaccination in the last 4 weeks
• Subject refusing genetic analysis for the present study
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 9, 2021
• Study Start: February 28, 2022
• Primary Completion: December 12, 2025
• Study Completion: December 17, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

FR (1)