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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

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.

Condition or disease Intervention/treatment Phase
ANCA Associated Vasculitis Biological: blood sample Biological: urine sample Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Soluble CD95 Ligand Role in the Pathophysiology of ANCA Associated Vasculitis
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: ANCA associated vasculitis Biological: blood sample
30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Biological: urine sample
6 ml




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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 ]
  4. 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 ]


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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:

  • 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)

Information from the National Library of Medicine

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): NCT03698071


Contacts
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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

Locations
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France
CHU de Bordeaux - Service d'Immunologie et Immunogénétique Recruiting
Bordeaux, France
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   
Principal Investigator: Patrick BLANCO, Prof         
Sub-Investigator: Christophe RICHEZ, Prof         
Sub-Investigator: Marie-Elise TRUCHETET, MD, PhD         
Sub-Investigator: Lionel COUZI, Prof         
Sub-Investigator: Estibaliz LAZARO, Prof         
Sub-Investigator: Julien SENESCHAL, Prof         
Sub-Investigator: Pierre DUFFAU, MD, PhD         
Sponsors and Collaborators
University Hospital, Bordeaux
National Research Agency, France
Investigators
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Principal Investigator: Patrick BLANCO, Prof CHU - Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03698071     History of Changes
Other Study ID Numbers: CHUBX 2018/22
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by University Hospital, Bordeaux:
ANCA associated vasculitis
Granulomatosis with polyangiitis
microscopic polyangiitis
eosinophilic granulomatosis with polyangiitis
soluble-CD95-Ligand

Additional relevant MeSH terms:
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Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vascular Diseases
Cardiovascular Diseases
Systemic Vasculitis
Autoimmune Diseases
Immune System Diseases
Antibodies, Antineutrophil Cytoplasmic
Immunologic Factors
Physiological Effects of Drugs