Investigating the role of innate T cells in systemic sclerosis
Role of Innate T Cells in Physiopathology of Systemic Sclerosis
This study is testing how certain immune cells called innate T cells might be involved in the inflammation seen in people with systemic sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Poitiers) |
| Trial ID | NCT04995588 on ClinicalTrials.gov |
What this trial studies
This study examines the role of innate T cells (ITC) in patients with systemic sclerosis (SSc) and their potential involvement in the disease's inflammatory processes. The researchers hypothesize that chronic stimulation of ITC by innate signals leads to their exhaustion, which may contribute to endotheliopathy and fibroblast activation in SSc. Participants will undergo blood tests to assess the physiological mechanisms related to ITC in SSc and other connective tissue diseases. The study aims to gather data that could enhance understanding of SSc and its underlying mechanisms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with systemic sclerosis or other specified connective tissue diseases.
Not a fit: Patients with overlap syndromes or those who have undergone recent chemotherapy or stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the mechanisms of systemic sclerosis and lead to new therapeutic strategies.
How similar studies have performed: While there is limited data on the specific role of ITC in systemic sclerosis, similar studies have explored immune cell dynamics in autoimmune diseases, indicating potential for novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Poitiers
- CHU poitiers — Poitiers, France (Recruiting)
Study contacts
- Study coordinator: Mickaël MARTIN, MD, PhD
- Email: mickael.martin@chu-poitiers.fr
- Phone: +33549444004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.