Status:
COMPLETED
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Vasculitis
Wegener's Granulomatosis
Eligibility:
All Genders
65+ years
Phase:
PHASE4
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-effect...
Eligibility Criteria
Inclusion
- Newly diagnosed WG, MPA, PAN without HBV infection, or CSS
- Patients can be still be enrolled within 1 month after starting corticosteroids if prescribed according to protocol.
- within or after the 65th of anniversary
- Age ≥ 65 years
Exclusion
- Any cytotoxic drug within previous year
- Co-existence of another systemic autoimmune disease, e.g., SLE, RA
- Virus-associated vasculitides
- HIV positivity
- Malignancy (usually excluded unless approved by the trial coordinator)
- Age \< 65 years
- Inability to give informed consent
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00307671
Start Date
July 1 2005
End Date
July 1 2011
Last Update
September 12 2011
Active Locations (1)
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1
Hôpital Cochin
Paris, France, 75679