Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years

Study Overview
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Brief Summary
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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
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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).

Official Title
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Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants

Conditions
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Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa

Intervention / Treatment
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* Drug: prednisone, methylprednisolone,cyclophosphamides
* Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
* Drug: Mycophenolate mofetil,methotrexate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>conventional treatment | Drug: prednisone, methylprednisolone,cyclophosphamides<br>* treatment conventional<br>Drug: Mycophenolate mofetil,methotrexate<br>* in the treatment conventional and in the reduction dose<br>|
| Experimental: B<br>reduction dose | Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone<br>* reduction dose<br>Drug: Mycophenolate mofetil,methotrexate<br>* in the treatment conventional and in the reduction dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of side effects (morbidity) |  | at 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic necrotizing vasculitides, corticosteroids; azathioprine; mycophenolate mofetil;, cyclophosphamide, Elderly patients, Randomized controlled trial