Vasculopathy, Inflammation and Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— VISS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562079
• Other study ID #: CHUBX 2011/37
• Status: Completed
• Phase: N/A
• First received: December 29, 2014
• Last updated: April 5, 2017
• Start date: March 2012
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis
• Vascular Diseases

Intervention

Biological:
• Blood samples
biological features of the standard follow-up 2 more blood tube for the biological collection (serum and PBMC)
• Biopsy
Skin biopsies

Locations

Country	Name	City	State
France	Service de Rhumatologie - Tripode - Hôpital Pellegrin	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Société Française de Rhumatologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of OX40L expression in endothelial cells and skin biopsies.		Day 1