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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02562079 |
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Date of registration:
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29/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Vasculopathy, Inflammation and Systemic Sclerosis
VISS |
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Scientific title:
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Vasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte Activation |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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350 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02562079 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Marie-Elise TRUCHETET, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Bordeaux, France |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Sclerosis
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Intervention(s)
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Biological: Biopsy
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Biological: Blood samples
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Primary Outcome(s)
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Assessment of OX40L expression in endothelial cells and skin biopsies.
[Time Frame: Day 1]
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Secondary ID(s)
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CHUBX 2011/37
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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