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.
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 68,4 % 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 factor(s) of poor prognosis is present (this latter regimen relying on previously published therapeutic guidelines).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
treatment conventional
reduction dose
in the treatment conventional and in the reduction dose
Hôpital Cochin
Paris, France
Number of side effects (morbidity)
Time frame: at 3 years
Survival
Time frame: at 3 years
Efficacy of treatment (remission rate)
Time frame: during the 3 years
Relapse rate
Time frame: at 3 years
Cumulative dose exposure to OCS and AZA
Time frame: at 3 years
Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values
Time frame: at 3 years
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