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Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis (Sclerocadh1)

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ClinicalTrials.gov Identifier: NCT02212249
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Primary Raynaud Disease Systemic Sclerosis Biological: soluble Ve cadherin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis
Study Start Date : May 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Systemic sclerosis
patients with systemic sclerosis
 Biological: soluble Ve cadherin
dosage of soluble VE cadherine in each arms
Sham Comparator: primary raynaud disease
patients with primary raynaud disease
 Biological: soluble Ve cadherin
dosage of soluble VE cadherine in each arms


Outcome Measures
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Primary Outcome Measures :
  1. Level of soluble Ve-cadherin and antibody VE-cadherin with ELISA TEST in Scleroderma group versus Primary Raynaud's Phenomenon [ Time Frame: At 30 days average ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • group 1: systemic sclerosis
  • group 2: raynaud primary disease
Contacts and Locations
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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): NCT02212249


Locations
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France
Grenoble University Hospital
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02212249     History of Changes
Other Study ID Numbers: 2014-A00186-41
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016
Keywords provided by University Hospital, Grenoble:
soluble VE-cadherin
antibody
systemic slerosis
Additional relevant MeSH terms:
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Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
 Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs