Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years

Phase 4

Completed

• Conditions: Vasculitis; Wegener's Granulomatosis; Microscopic Polyangiitis; Churg-Strauss Syndrome; Polyarteritis Nodosa
• Interventions: Drug: prednisone, methylprednisolone,cyclophosphamides; Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone; Drug: Mycophenolate mofetil,methotrexate

• Registration Number: NCT00307671
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-28
• Status Verified: 2007-03
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-09-09
• Last Update Posted: 2011-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	prednisone, methylprednisolone,cyclophosphamides	conventional treatment
A	Mycophenolate mofetil,methotrexate	conventional treatment
B	Cyclophosphamide, Azathioprine,prednisone,methylprednisolone	reduction dose
B	Mycophenolate mofetil,methotrexate	reduction dose

Primary Outcome Measures

Name	Time	Method
Number of side effects (morbidity)	at 3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Cochin; 🇫🇷 Paris, France