Skip to main content
OpenTrials
Completed

NCT Number: NCT04995588

Systemic Sclerosis and Innate T Cells

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU poitiers

Poitiers, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Blood Test

Other

Unique blood draw of 45mL for all the participants

Primary outcomes

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

    Time frame: Through study completion, an average of 1 year

    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)

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

    Time frame: Through study completion, an average of 1 year

    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)

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

    Time frame: Through study completion, an average of 1 year

    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)

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

    Time frame: Through study completion, an average of 1 year

    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)

  5. 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

    Time frame: Through study completion, an average of 1 year

    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)

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Role of Innate T Cells in Physiopathology of Systemic Sclerosis

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.