Vasculopathy, Inflammation and Systemic Sclerosis

Not Applicable

Completed

• Conditions: Systemic Sclerosis
• Interventions: Biological: Blood samples; Biological: Biopsy

• Registration Number: NCT02562079
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2014-12-29
• Study First Submitted QC: 2015-09-25
• Study First Posted: 2015-09-29
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subjects Sc	Blood samples	-
subjects SSc diagnosed	Blood samples	-
subjects Localised sclerosis diagnosed	Blood samples	-
subjects Localised sclerosis diagnosed	Biopsy	-
subjects SSc diagnosed	Biopsy	-

Primary Outcome Measures

Name	Time	Method
Assessment of OX40L expression in endothelial cells and skin biopsies.	Day 1

Trial Locations

Locations (1)

Service de Rhumatologie - Tripode - Hôpital Pellegrin; 🇫🇷 Bordeaux, France