Evolution of Neuropathies Associated With Necrotizing Vasculitis
NCT ID: NCT05164822
Last Updated: 2023-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
10 participants
OBSERVATIONAL
2022-02-14
2022-10-19
Brief Summary
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Peripheral neurological impairment is rarely life threatening (except when associated with other visceral impairment which, in turn, require urgent management with a severity score defined by the Five Factor Score) but impacts the functional outcome by sequelae evaluated by the Vascular Disease Index (VDI).
Four retrospective studies were published with low number of participants, and also mix subgroups of vasculitis Anti-Neutrophil Cytoplasmatic Antibodies (ANCA)+/- GPA (Granulomatosis with polyangiitis), Eosinophilic granulomatosis with polyangiitis (EGPA), Microscopic polyangiitis (MPA), Polyarteritis nodosa (PAN), and Non Systemic Vasculitic Neuropathy (NSVN) and Systemic Vasculitic Neuropathy (SVN).
Overall, management of Necrotizing Vasculitis has evolved significantly over the last two decades, with a dramatic improvement in survival, thanks to new therapeutic strategies and medications. Five-year survival increased from 85% for diagnoses made between 1990 and 1999 to 94.5% for diagnoses made after 2010 Evaluation of relapses of vasculitis, late macro vascular complications, medical-economic evaluation of therapeutic strategies and functional impairment of neuropathies are at the heart of current medical concerns with a view to improve vital and functional prognosis.
Various tests for the evaluation of peripheral neurological damage appear to be relevant tools in vasculitis, although they are not specific: Muscular force scale Medical research council (MRC), Rasch-built overall disability scale (RODS), Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Construction and validation of the chronic acquired polyneuropathy patient-reported index (CAP-PRI), Health-Related Quality of Life (HR QOL), Medical Interview Satisfaction Scale (MISS), Neuropsychological Impairment Scale (NIS) associated to results of repeated Electromyography.
In this study, MRC, NIS and RODS measurements were chosen for their reproducibility and practicality.
In addition to the immediate or relapse mortality factors assessed by the five-factor score (FFS), a functional morbidity score specific to neuropathies related to necrotizing vasculitis must be developed, as well as the determination of the neurosensory disorders and macro-vascular complications. Therefore it is proposed in this observational study to determine the factors that can be predictive of the functional evolution, in order to build a risk score.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Necrotizing Vasculitis
Patient with an initial diagnosis or a relapse of :
\- Systemic Vasculitic Neuropathy (SVN): Primary Necrotizing Vasculitis answering the Chapel Hill Consensus Conference criteria associated with a symptomatic Vasculitic Peripheral Neuropathy
Or
\- Non Systemic Vasculitic Neuropathy (NSVN): pure symptomatic peripheral neurological impairment without systemic visceral impairment
Necrotizing Vasculitis
Pain scale Diagnosis of necrotizing vasculitis and peripheral neuropathy, Clinical characteristics of the disease, Biological analysis, Treatment and evolution of the disease,
Questionnaires :
Neuropathy Impairment Score (NIS) sensitive sub-questionnaire that measures extremity sensitivity.
MRC (Medical Research Council), which evaluates three motor functions on each member.
RODS questionnaire on the relationship between your daily activities and your health.
BVAS (Birmingham Vasculitis Activity Score) disease activity questionnaire. VDI (Vasculitis Damage Index) questionnaire evaluates the sequelae of the disease.
Rankin Score modified to measure the degree of disability
Two tests will be performed:
EMG (electromyogram) to evaluate the electrical activity of the muscles, Walking Test of 10 meters which aims to measure the time taken to travel 10 meters.
Interventions
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Necrotizing Vasculitis
Pain scale Diagnosis of necrotizing vasculitis and peripheral neuropathy, Clinical characteristics of the disease, Biological analysis, Treatment and evolution of the disease,
Questionnaires :
Neuropathy Impairment Score (NIS) sensitive sub-questionnaire that measures extremity sensitivity.
MRC (Medical Research Council), which evaluates three motor functions on each member.
RODS questionnaire on the relationship between your daily activities and your health.
BVAS (Birmingham Vasculitis Activity Score) disease activity questionnaire. VDI (Vasculitis Damage Index) questionnaire evaluates the sequelae of the disease.
Rankin Score modified to measure the degree of disability
Two tests will be performed:
EMG (electromyogram) to evaluate the electrical activity of the muscles, Walking Test of 10 meters which aims to measure the time taken to travel 10 meters.
Eligibility Criteria
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Inclusion Criteria
\- Systemic Vasculitic Neuropathy (SVN): Primary Necrotizing Vasculitis answering the Chapel Hill Consensus Conference criteria associated with a symptomatic Vasculitic Peripheral Neuropathy
Or
\- Non Systemic Vasculitic Neuropathy (NSVN): pure symptomatic peripheral neurological impairment without systemic visceral impairment
Exclusion Criteria
* Diabetes
* Chronic ethylism
* AL (immunoglobulin light chain) amyloidosis or TTR (transthyretin)
* Genetic neuropathies
* Toxic neuropathies
* Sequelae of sciatica
* Opposition to participation in the study
* Lack of social security
* Under guardianship or curatorship
18 Years
ALL
No
Sponsors
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UNEOS
UNKNOWN
Lille Catholic University
OTHER
Responsible Party
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Principal Investigators
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François Maurier, MD
Role: STUDY_CHAIR
UNEOS
Locations
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CHU Angers
Angers, , France
Hôpital Pellegrin
Bordeaux, , France
CH Boulogne-Sur-Mer
Boulogne-sur-Mer, , France
Centre Hospitalier Bourg-en-Bresse
Bourg-en-Bresse, , France
CHRU Brest
Brest, , France
Hôpital Percy
Clamart, , France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
CHU DIjon-Bourgogne
Dijon, , France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, , France
CHRU Lille
Lille, , France
CHU Limoges
Limoges, , France
Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, , France
Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon
Lyon, , France
AP-HM
Marseille, , France
Groupe Hospitalier Sud Ile de France
Melun, , France
CHR Metz
Metz, , France
UNEOS
Metz, , France
Groupe Hospitalier du Havre
Montivilliers, , France
CHRU Nancy
Nancy, , France
CHU Nantes
Nantes, , France
Hôpital de l'Archet
Nice, , France
Hôpital Pasteur
Nice, , France
CHU Bicêtre
Paris, , France
Groupe Hospitalier Paris Saint Joseph
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital La Pitié Salpétrière
Paris, , France
Hôpital Lariboisière
Paris, , France
Hôpital Saint-Antoine
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Centre Hospitalier Perpignan
Perpignan, , France
Hôpital Haut-Lévêque
Pessac, , France
CHU de Poitiers
Poitiers, , France
Centre Hospitalier de Cornouaille
Quimper, , France
CHU Saint-Etienne
Saint-Etienne, , France
Centre Hospitalier Saint-Malo
St-Malo, , France
CHU Strasbourg
Strasbourg, , France
Hôpital Foch
Suresnes, , France
Hôpital de Rangueil
Toulouse, , France
Hôpital Pierre-Paul Riquet
Toulouse, , France
Centre Hospitalier Bretagne-Atlantique
Vannes, , France
Countries
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Other Identifiers
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RC-P0092
Identifier Type: -
Identifier Source: org_study_id
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