CORTAGE: Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00307671

Collaborator

(none)

108

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vasculitis Wegener's Granulomatosis Microscopic Polyangiitis Churg-Strauss Syndrome Polyarteritis Nodosa	Drug: prednisone, methylprednisolone,cyclophosphamides Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone Drug: Mycophenolate mofetil,methotrexate	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: A conventional treatment	Drug: prednisone, methylprednisolone,cyclophosphamides treatment conventional Drug: Mycophenolate mofetil,methotrexate in the treatment conventional and in the reduction dose
Experimental: B reduction dose	Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone reduction dose Drug: Mycophenolate mofetil,methotrexate in the treatment conventional and in the reduction dose

Arm

Intervention/Treatment

Other: A

conventional treatment

Drug: prednisone, methylprednisolone,cyclophosphamides

treatment conventional

Drug: Mycophenolate mofetil,methotrexate

in the treatment conventional and in the reduction dose

Experimental: B

reduction dose

Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone

reduction dose

Drug: Mycophenolate mofetil,methotrexate

in the treatment conventional and in the reduction dose

Outcome Measures

Primary Outcome Measures

Number of side effects (morbidity) [at 3 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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