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Completed

NCT Number: NCT00307671

Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prednisone, methylprednisolone,cyclophosphamides

Drug

treatment conventional

Cyclophosphamide, Azathioprine,prednisone,methylprednisolone

Drug

reduction dose

Mycophenolate mofetil,methotrexate

Drug

in the treatment conventional and in the reduction dose

Primary outcomes

  1. Number of side effects (morbidity)

    Time frame: at 3 years

Secondary outcomes

  1. Survival

    Time frame: at 3 years

  2. Efficacy of treatment (remission rate)

    Time frame: during the 3 years

  3. Relapse rate

    Time frame: at 3 years

  4. Cumulative dose exposure to OCS and AZA

    Time frame: at 3 years

  5. Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values

    Time frame: at 3 years

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: CORTAGE

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Mar 28, 2006
Registry last updated
Sep 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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