NCT04995588Completed
Systemic Sclerosis and Innate T Cells
Role of Innate T Cells in Physiopathology of Systemic Sclerosis
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 235 (actual)
- First submitted
- 23 Jul 2021
- Start date
- 28 Feb 2022
- Primary completion date
- 12 Dec 2025
- Lead sponsor
- Poitiers University Hospital
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT04995588
What you commit to
- Study type: Interventional
- Participants enrolled: 235
- From 28 Feb 2022 to the primary completion date, 12 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Past of autologous or allogenic hematopoietic stem cell transplantation
- Chemotherapy and/or immune checkpoint inhibitors in the last 12 months
Other illness
- Overlap syndrome (including secondary Sjögren syndrome)
- Solid neoplasia or malignant hemopathy in remission for less than 12 months an
- Active infection and/or antibiotics in the last 2 weeks
- Known active chronic infection among HIV, HTLV, viral hepatitis, syphilis
Other
- Weight \<55 kgs
- Known primary cell immunodeficiency
- Systemic retinoids
- Vaccination in the last 4 weeks
- Subject refusing genetic analysis for the present study
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.