Vasculopathy, Inflammation and Systemic Sclerosis (VISS)

University Hospital of Bordeaux

Status: Completed

Conditions: Systemic Sclerosis

Treatments: Biological: Biopsy; Biological: Blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02562079

CHUBX 2011/37

Details and patient eligibility

About

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

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 3 patient groups

subjects SSc diagnosed

Experimental group

Treatment:

Biological: Blood samples

Biological: Biopsy

subjects Localised sclerosis diagnosed

Experimental group

Treatment:

Biological: Blood samples

Biological: Biopsy

subjects Sc

Experimental group

Treatment:

Biological: Blood samples