ANCA Associated Vasculitis Clinical Trial
— VASC-FASOfficial title:
Soluble CD95 Ligand Role in the Pathophysiology of ANCA Associated Vasculitis
The study aims at defining the role of soluble CD95 Ligand in the physiopathology of a rare group of inflammatory diseases: ANCA associated vasculitis. Soluble CD95 Ligand might have a prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of ANCA associated vasculitis according to the Chapel-Hill Consensus Conference - 2012 modified version - Age = 18 years - being affiliated to health insurance - willing to participate and to sign informed consent. Exclusion Criteria: - Pregnant or breastfeeding women, - patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent) |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux - Service d'Immunologie et Immunogénétique | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | National Research Agency, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of quantitative levels of s-CD95-L in ANCA associated vasculitis between baseline and Month 12 | At baseline (Day 0) and 12 months from baseline | ||
Secondary | Change of disease activity scores for ANCA associated vasculitis between baseline and Month 12 | Birmingham Vasculitis Activity Score - Version 3 (BVAS 3.0) The Birmingham Vasculitis Activity Score (BVAS) is a method for assessing the activity of vasculitis. Note that scoring ranges are higher when any of the features are new or worse. Creatinine levels can be scored at patient's first assessment only. The maximum score is 63 points for present symptoms and 32 points for new symptoms or symptoms which had worsened within the previous weeks. | At baseline (Day 0) and 12 months from baseline | |
Secondary | Change of disease activity scores for ANCA associated vasculitis between baseline and Month 12 | Vasculitis Damage Index (VDI) | At baseline (Day 0) and 12 months from baseline | |
Secondary | Change of quantification of s-CD95-L in the blood and urine samples of ANCA associated vasculitis between baseline and Month 12 | At baseline (Day 0) and 12 months from baseline | ||
Secondary | Change of quantification of ANCA in the blood samples of ANCA associated vasculitis between baseline and Month 12 | At baseline (Day 0) and 12 months from baseline |
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