Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis

Systemic Sclerosis Clinical Trial

— Sclerocadh1  

Official title:

Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212249
• Other study ID #: 2014-A00186-41
• Status: Completed
• Phase: N/A
• First received: April 23, 2014
• Last updated: March 23, 2016
• Start date: May 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Ve-cadherin is expressed in endothelial cells. Systemic slerosis is a rare auto-immune disease with a endothelial dysfunction. This study is to evaluated the level of soluble VE-cadherin and VE-cadherin antibody in patients with systemic slerosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• group 1: systemic sclerosis

• group 2: raynaud primary disease

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Primary Raynaud Disease
• Raynaud Disease
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Biological:
• soluble Ve cadherin
dosage of soluble VE cadherine in each arms

Locations

Country	Name	City	State
France	Grenoble University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of soluble Ve-cadherin and antibody VE-cadherin with ELISA TEST in Scleroderma group versus Primary Raynaud's Phenomenon	Level of human sVE and antibody VE-cadherin in blood will be determined by ELISA test in both groups Scleroderma and Primary Raynaud's Phenomenon.; The methodology of dosage of sVE is based on the pattern:WO/2008/062314 The methodolody of the dosage of antibody VE-cadherin is based on the pattern WO/2012/136820 .; Group Scleroderma (N=60) versus Primary Raynaud's Phenomenon (N=20). Shapiro test.	At 30 days average	No