Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years (CORTAGE)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 4

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

Treatments: Drug: prednisone, methylprednisolone,cyclophosphamides; Drug: Mycophenolate mofetil,methotrexate; Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00307671

P040425

Details and patient eligibility

About

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.

Full 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).

Enrollment: 108 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

A

Other group

Description:

conventional treatment

Treatment:

Drug: prednisone, methylprednisolone,cyclophosphamides

Drug: Mycophenolate mofetil,methotrexate

B

Experimental group

Description:

reduction dose

Treatment:

Drug: Mycophenolate mofetil,methotrexate

Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone