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Vasculopathy, Inflammation and Systemic Sclerosis (VISS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562079
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
Societe Francaise de Rhumatologie
Information provided by (Responsible Party):
University Hospital, Bordeaux

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

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Biological: Blood samples Biological: Biopsy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Vasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte Activation
Actual Study Start Date : March 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: subjects SSc diagnosed Biological: Blood samples
  • biological features of the standard follow-up
  • 2 more blood tube for the biological collection (serum and PBMC)

Biological: Biopsy
Skin biopsies

Experimental: subjects Localised sclerosis diagnosed Biological: Blood samples
  • biological features of the standard follow-up
  • 2 more blood tube for the biological collection (serum and PBMC)

Biological: Biopsy
Skin biopsies

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




Primary Outcome Measures :
  1. Assessment of OX40L expression in endothelial cells and skin biopsies. [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562079


Locations
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France
Service de Rhumatologie - Tripode - Hôpital Pellegrin
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Societe Francaise de Rhumatologie
Investigators
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Principal Investigator: Marie-Elise TRUCHETET, MD University Hospital Bordeaux, France
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02562079    
Other Study ID Numbers: CHUBX 2011/37
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Keywords provided by University Hospital, Bordeaux:
T lymphocyte
OX40/OX40L
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Inflammation
Pathologic Processes
Connective Tissue Diseases
Skin Diseases