Churg-Strauss Syndrome, Microscopic Polyangiitis, Polyarteritis Nodosa, Vasculitis, Wegener's Granulomatosis
Conditions
Keywords
Systemic necrotizing vasculitides, corticosteroids; azathioprine; mycophenolate mofetil;, cyclophosphamide, Elderly patients, Randomized controlled trial
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 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).
Interventions
DRUGprednisone, methylprednisolone,cyclophosphamides
treatment conventional
DRUGCyclophosphamide, Azathioprine,prednisone,methylprednisolone
reduction dose
DRUGMycophenolate mofetil,methotrexate
in the treatment conventional and in the reduction dose
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of side effects (morbidity) | at 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Survival | at 3 years |
| Efficacy of treatment (remission rate) | during the 3 years |
| Relapse rate | at 3 years |
| Cumulative dose exposure to OCS and AZA | at 3 years |
| Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values | at 3 years |
Countries
France
Outcome results
None listed