Systemic Sclerosis and Innate T Cells

NCT ID: NCT04995588

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2026-01-28

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Blood test

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

Group Type OTHER

Blood test

Intervention Type OTHER

Unique blood draw of 45mL for all the participants

Interventions

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Blood test

Unique blood draw of 45mL for all the participants

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU poitiers

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mickaël MARTIN, MD, PhD

Role: CONTACT

+33549444004

Facility Contacts

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MICKAEL MARTIN, MD, PhD

Role: primary

+33.5.49.44.40.04

Other Identifiers

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Sclero-LTI

Identifier Type: -

Identifier Source: org_study_id

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