Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years

Vasculitis Clinical Trial

— CORTAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307671
• Other study ID #: P040425
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2006
• Last updated: September 9, 2011
• Start date: July 2005
• Est. completion date: July 2011

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Churg-Strauss Syndrome
• Microscopic Polyangiitis
• Polyarteritis Nodosa
• Systemic Vasculitis
• Vasculitis
• Wegener Granulomatosis
• Wegener's Granulomatosis

Intervention

Drug:
• prednisone, methylprednisolone,cyclophosphamides
treatment conventional
• Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
reduction dose
• Mycophenolate mofetil,methotrexate
in the treatment conventional and in the reduction dose

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of side effects (morbidity)		at 3 years	No
Secondary	Survival		at 3 years	Yes
Secondary	Efficacy of treatment (remission rate)		during the 3 years	Yes
Secondary	Relapse rate		at 3 years	Yes
Secondary	Cumulative dose exposure to OCS and AZA		at 3 years	Yes
Secondary	Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values		at 3 years	No