Vasculopathy, Inflammation and Systemic Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Systemic Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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subjects SSc diagnosed

Group Type EXPERIMENTAL

Blood samples

Intervention Type BIOLOGICAL

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

Biopsy

Intervention Type BIOLOGICAL

Skin biopsies

subjects Localised sclerosis diagnosed

Group Type EXPERIMENTAL

Blood samples

Intervention Type BIOLOGICAL

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

Biopsy

Intervention Type BIOLOGICAL

Skin biopsies

subjects Sc

Group Type EXPERIMENTAL

Blood samples

Intervention Type BIOLOGICAL

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

Interventions

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Blood samples

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

Intervention Type BIOLOGICAL

Biopsy

Skin biopsies

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No