Hôpital Cochin
Paris, 75679, France
NCT Number: NCT00307671
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.
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Notify Me65 year and older
All sexes
Interventional
Phase 4
Paris, 75679, France
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
treatment conventional
reduction dose
in the treatment conventional and in the reduction dose
Time frame: at 3 years
Time frame: at 3 years
Time frame: during the 3 years
Time frame: at 3 years
Time frame: at 3 years
Time frame: at 3 years
Assistance Publique - Hôpitaux de Paris
Other
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants
Acronym: CORTAGE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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