Trials / Completed
CompletedNCT00307671
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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 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).
Conditions
- Vasculitis
- Wegener's Granulomatosis
- Microscopic Polyangiitis
- Churg-Strauss Syndrome
- Polyarteritis Nodosa
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | prednisone, methylprednisolone,cyclophosphamides | treatment conventional |
| DRUG | Cyclophosphamide, Azathioprine,prednisone,methylprednisolone | reduction dose |
| DRUG | Mycophenolate mofetil,methotrexate | in the treatment conventional and in the reduction dose |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2006-03-28
- Last updated
- 2011-09-12
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00307671. Inclusion in this directory is not an endorsement.