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Search / Trial NCT04995588

Systemic Sclerosis and Innate T Cells

Launched by POITIERS UNIVERSITY HOSPITAL · Jul 29, 2021

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a condition called systemic sclerosis (SSc), which affects the skin and internal organs by causing them to become thick and hard. The researchers are particularly interested in a type of immune cell called innate T cells (ITCs), which seem to be less active in people with SSc. The goal is to understand how these cells might be related to inflammation and other problems in SSc, as well as why they might become worn out over time.

To participate in this study, you need to be at least 18 years old and have a diagnosis of systemic sclerosis or other specific autoimmune diseases like lupus or rheumatoid arthritis. Healthy individuals without autoimmune diseases are also welcome to join. If you qualify, you can expect to undergo some tests and provide information that will help researchers learn more about the role of these immune cells in systemic sclerosis. It's important to note that there are some exclusions, such as recent chemotherapy or pregnancy, so potential participants should check the full criteria. This study aims to shed light on the underlying mechanisms of SSc and could lead to better understanding and treatment options in the future.

Gender

ALL

Eligibility 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

About Poitiers University Hospital

Poitiers University Hospital is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and trials. As a prominent sponsor of clinical studies, the hospital leverages its multidisciplinary expertise and state-of-the-art facilities to explore new therapeutic interventions and improve patient outcomes. With a commitment to ethical standards and patient safety, Poitiers University Hospital collaborates with healthcare professionals, researchers, and institutions to facilitate groundbreaking studies that contribute to medical knowledge and enhance treatment protocols across various specialties.

Locations

Poitiers, France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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