Systemic Sclerosis and Innate T Cells (NCT04995588) | Clinical Trial Compass
CompletedNot Applicable
Systemic Sclerosis and Innate T Cells
France235 participantsStarted 2022-02-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Basal numeration of circulating ITC (iNKT, MAIT, γδ-T and innate CD8(+) T-cells)
Timeframe: Through study completion, an average of 1 year
2
Basal expression level of Ki67 among circulating ITC (iNKT, MAIT, γδ-T and innate CD8(+) T-cells)
Timeframe: Through study completion, an average of 1 year
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)
Timeframe: Through study completion, an average of 1 year
4
Basal expression of perforin AND granzyme A among circulating ITC (iNKT, MAIT, γδ-T and innate CD8(+) T-cells)
Timeframe: Through study completion, an average of 1 year
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
Timeframe: Through study completion, an average of 1 year