Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years

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Brief Title

Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years

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 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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

Number of side effects (morbidity)

Secondary Outcome

 Survival

Condition

Vasculitis

Intervention

prednisone, methylprednisolone,cyclophosphamides

Study Arms / Comparison Groups

 A
Description:  conventional treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

108

Start Date

July 2005

Completion Date

July 2011

Primary Completion Date

July 2011

Eligibility Criteria

        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
      

Gender

All

Ages

65 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Loïc Guillevin, MD,PhD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00307671

Organization ID

P040425


Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

Loïc Guillevin, MD,PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris


Verification Date

March 2007