Clinical Trial: Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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).


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Number of side effects (morbidity) [ Time Frame: at 3 years ]

Original Primary Outcome:

  • The primary end point is:
  • the number of side effects at 3 years (morbidity)


Current Secondary Outcome:

  • Survival [ Time Frame: at 3 years ]
  • Efficacy of treatment (remission rate) [ Time Frame: during the 3 years ]
  • Relapse rate [ Time Frame: at 3 years ]
  • Cumulative dose exposure to OCS and AZA [ Time Frame: at 3 years ]
  • Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values [ Time Frame: at 3 years ]


Original Secondary Outcome:

  • Survival at 3 years
  • Efficacy of treatment (remission rate)
  • Relapse rate at 3 years
  • Cumulative dose exposure to OCS and AZA
  • Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: March 27, 2006
Date Started: July 2005
Date Completion:
Last Updated: September 9, 2011
Last Verified: March 2007