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

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ClinicalTrials.gov Identifier: NCT03698071
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
National Research Agency, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE October 4, 2018
First Posted Date  ICMJE October 5, 2018
Last Update Posted Date January 14, 2019
Actual Study Start Date  ICMJE December 14, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
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
Change History Complete list of historical versions of study NCT03698071 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • 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) 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.
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE ANCA Associated Vasculitis
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  ICMJE Experimental: ANCA associated vasculitis
Interventions:
  • Biological: blood sample
  • Biological: urine sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 4, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Patrick BLANCO, Prof (0)5 56 79 56 45 ext +33 patrick.blanco@chu-bordeaux.fr
Contact: Thomas BARNETCHE, PhD (0)5.57.82.04.93 ext +33 thomas.barnetche@chu-bordeaux.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03698071
Other Study ID Numbers  ICMJE CHUBX 2018/22
Has Data Monitoring Committee No
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  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE National Research Agency, France
Investigators  ICMJE
Principal Investigator: Patrick BLANCO, Prof CHU - Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date January 2019

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