Soluble CD95 Ligand Role in the Pathophysiology of Antineutrophil Cytoplasmic Antibody (ANCA) Associated Vasculitis

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 4, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

October 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change of quantitative levels of s-CD95-L in ANCA associated vasculitis between baseline and Month 12[ Time Frame: At baseline (Day 0) and 12 months from baseline ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Change of disease activity scores for ANCA associated vasculitis between baseline and Month 12[ Time Frame: At baseline (Day 0) and 12 months from baseline ]
Birmingham Vasculitis Activity Score - Version 3 (BVAS 3.0)
Change of disease activity scores for ANCA associated vasculitis between baseline and Month 12[ Time Frame: At baseline (Day 0) and 12 months from baseline ]
Vasculitis Damage Index (VDI)
Change of quantification of s-CD95-L in the blood and urine samples of ANCA associated vasculitis between baseline and Month 12[ Time Frame: At baseline (Day 0) and 12 months from baseline ]
Change of quantification of ANCA in the blood samples of ANCA associated vasculitis between baseline and Month 12[ Time Frame: At baseline (Day 0) and 12 months from baseline ]

Descriptive Information

Brief Title ^ICMJE

Soluble CD95 Ligand Role in the Pathophysiology of Antineutrophil Cytoplasmic Antibody (ANCA) Associated Vasculitis

Official Title ^ICMJE

Soluble CD95 Ligand Role in the Pathophysiology of ANCA Associated Vasculitis

Brief Summary

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.

Detailed Description

ANCA associated vasculitis are a rare group of diseases and potentially life-threatening inflammatory conditions. There is an urgent need to describe prognostic factors and to discover new therapeutic pathways. Soluble CD95-L is a cleaved part of CD95-L which binds the CD95 Death receptor. s-CD95-L has pro-inflammatory properties for Th17 lymphocytes and Neutrophils, two cells implicated in ANCA associated vasculitis. It also plays a role in systemic lupus erythematosus (which present with the same type of renal glomerulonephritis as ANCA-associated vasculitis). Finally, it has already be found elevated in this group of diseases. The investigators hypothesized that s-CD95-L levels might be a prognostic factor in ANCA associated vasculitis and the study of the molecular mechanisms involved could provide new therapeutic targets. The study will recruit 50 patients with ANCA associated vasculitis followed in Bordeaux University Hospital. Among classical disease activity information, blood and urine samples will be collected at each visit to study s-CD95-L. Fundamental research will be realized on patients' sample to study molecular mechanisms involved. Clinical and biological disease activity, treatment and outcomes will be studied in correlation with s-CD95-L to describe their potential prognostic role. Patients will be followed at regular intervals, as their usual follow-up would request. No extra visit will be needed and blood samples will be drawn at the same time as those drawn for clinical purposes.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

Biological: blood sample
30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
Biological: urine sample
6 ml

Study Arms

Experimental: ANCA associated vasculitis

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2021

Estimated Primary Completion Date

October 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University Hospital, Bordeaux

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Patrick BLANCO, Prof CHU - Bordeaux

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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