NCT03698071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 14, 2018

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2024

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

5.8 years

First QC Date

October 4, 2018

Last Update Submit

May 26, 2025

Conditions

ANCA Associated Vasculitis

Keywords

ANCA associated vasculitisGranulomatosis with polyangiitismicroscopic polyangiitiseosinophilic granulomatosis with polyangiitissoluble-CD95-Ligand

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change of disease activity scores for ANCA associated vasculitis between baseline and Month 12

    At baseline (Day 0) and 12 months from baseline

  • Change of disease activity scores for ANCA associated vasculitis between baseline and Month 12

    At baseline (Day 0) and 12 months from baseline

  • 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

  • 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

Study Arms (1)

ANCA associated vasculitis

EXPERIMENTAL
Biological: blood sampleBiological: urine sample

Interventions

blood sampleBIOLOGICAL

30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

ANCA associated vasculitis
urine sampleBIOLOGICAL

6 ml

ANCA associated vasculitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - Service d'Immunologie et Immunogénétique

Bordeaux, France

Location

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisGranulomatosis with PolyangiitisMicroscopic PolyangiitisChurg-Strauss Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Systemic VasculitisVasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGranulomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Patrick BLANCO, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 5, 2018

Study Start

December 14, 2018

Primary Completion

September 18, 2024

Study Completion

September 18, 2024

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)