Vasculopathy, Inflammation and Systemic Sclerosis (VISS)

May 11, 2026 updated by: University Hospital, Bordeaux

Vasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte Activation

It is a study of basic research with mechanistically objectives and including clinical biological samples.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Systemic sclerosis (SSc) is a rare and severe disease characterised by a fibrotic process and an incompletely elucidate physiopathology. Several shared featured have been identified between SSc and another autoimmune disease, the systemic lupus erythematous (SLE) as an interferon-alpha signature, the role of platelets and the polymorphism of OX40 ligand (OX40L). In SLE, OX40L has been shown highly linked to the active form of the disease, was increased by the CD40L of platelets and induced the CD8 cytotoxicity while inhibiting the suppressive functions of regulator T lymphocytes. The third main factor of the SSc physiopathology apart from autoimmunity and fibrosis is the vasculopathy with an important role of endothelial cells (EC). They turned out to be half-professional antigen presenting cells and can modulate the adaptive immunity.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bordeaux
      • Bordeaux, Bordeaux, France, 33076
        • Service de Rhumatologie - Tripode - Hôpital Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age from 18 to 75.
  • SSc diagnosed according to the American College of Rheumatology (ACR) criteria.
  • With skin manifestations since less than 10 years.
  • Localised sclerosis (LSc) diagnosed, morphea type.

Exclusion Criteria:

  • Age inferior to 18 or upper than 75.
  • Skin manifestations since more than 10 years.
  • Haemostasis diseases (independent from treatments).
  • Stem cell transplant.
  • Immunosuppressive treatments in the last 6 months.
  • Associate autoimmune disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: subjects SSc diagnosed
Biological: Blood samples
  • biological features of the standard follow-up
  • 2 more blood tube for the biological collection (serum and PBMC)
Biological: Biopsy
Skin biopsies
Experimental: subjects Localised sclerosis diagnosed
Biological: Blood samples
  • biological features of the standard follow-up
  • 2 more blood tube for the biological collection (serum and PBMC)
Biological: Biopsy
Skin biopsies
Experimental: subjects Sc
Biological: Blood samples
  • biological features of the standard follow-up
  • 2 more blood tube for the biological collection (serum and PBMC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of OX40L expression in endothelial cells and skin biopsies.
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Societe Francaise de Rhumatologie

Investigators

  • Principal Investigator: Marie-Elise TRUCHETET, MD, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 29, 2014

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimated)

September 29, 2015

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2011/37
  • 2012-A00081-42 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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