Systemic Sclerosis and Innate T Cells

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood test

About this trial

This is an interventional basic science trial for Systemic Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
Immunosuppressive drug in the past 3 months (hydroxychloroquine and glucocorticoids ≤7.5mg/d allowed)
Biotherapy in the past 6 months
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

Sites / Locations

CHU poitiersRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Blood test

Arm Description

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

Outcomes

Primary Outcome Measures

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)

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)

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)

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)

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT04995588

First Posted

July 23, 2021

Last Updated

September 6, 2023

Sponsor

Poitiers University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04995588

Brief Title

Systemic Sclerosis and Innate T Cells

Official Title

Role of Innate T Cells in Physiopathology of Systemic Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 28, 2022 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Sclerosis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Blood test

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Blood test

Intervention Description

Unique blood draw of 45mL for all the participants

Primary Outcome Measure Information:

Title

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

Description

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)

Time Frame