Vasculopathy, Inflammation and Systemic Sclerosis

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02562079

Acronym

VISS

Enrollment

350

Registered

2015-09-29

Start date

2012-03-01

Completion date

2016-12-01

Last updated

2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

Keywords

T lymphocyte, OX40/OX40L

Brief summary

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

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.

Interventions

BIOLOGICALBlood samples

* biological features of the standard follow-up * 2 more blood tube for the biological collection (serum and PBMC)

BIOLOGICALBiopsy

Skin biopsies

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Assessment of OX40L expression in endothelial cells and skin biopsies.	Day 1

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMarie-Elise TRUCHETET, MD

University Hospital Bordeaux, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026