Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05164822
Status:
TERMINATED
Last Update Posted:
2023-09-14
First Post:
2021-10-21
Brief Title:
Evolution of Neuropathies Associated With Necrotizing Vasculitis
Sponsor:
Lille Catholic University
Organization:
Lille Catholic University
Study Overview
Official Title:
Evolution of Neuropathies Associated With Necrotizing Vasculitis Prospective Non-interventional Multicentric Study
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient number of inclusions
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NERF-VASC
Brief Summary:
Necrotizing Vasculitis are inflammatory diseases of the wall of vessels Neurological damage of the peripheral nerve varies from 7 to 50 of cases depending on the type of Necrotizing Vasculitis
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 945 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
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 945 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None