Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307671
Status:
COMPLETED
Last Update Posted:
2011-09-12
First Post:
2006-03-27
Brief Title:
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORTAGE
Brief Summary:
The aim of this trial is to lower the morbidity rate in elderly patients affected with systemic necrotizing vasculitides by reducing mortality and improving global outcome
Detailed Description:
Systemic necrotizing vasculitides are severe diseases associated with a high mortality rate in elderly
Although corticosteroids and immunosuppressants are effective they can induce some side-effects especially in this latter patients
Preliminary data indicate that systemic necrotizing vasculitides SNV occurring in patients over 65 years have a poorer outcome than in younger patients mortality rate of 76 vs 69 at 5 years respectively and that 684 of the elderly experience treatment side-effects
In this trial patients will be randomly assigned to receive either low doses of corticosteroids systematically in combination with immunosuppressants CYC then azathioprine or usual regimen with corticosteroids combined with immunosuppressants only if factors of poor prognosis is present this latter regimen relying on previously published therapeutic guidelines
Although corticosteroids and immunosuppressants are effective they can induce some side-effects especially in this latter patients
Preliminary data indicate that systemic necrotizing vasculitides SNV occurring in patients over 65 years have a poorer outcome than in younger patients mortality rate of 76 vs 69 at 5 years respectively and that 684 of the elderly experience treatment side-effects
In this trial patients will be randomly assigned to receive either low doses of corticosteroids systematically in combination with immunosuppressants CYC then azathioprine or usual regimen with corticosteroids combined with immunosuppressants only if factors of poor prognosis is present this latter regimen relying on previously published therapeutic guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None