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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00307671
First received: March 27, 2006
Last updated: September 9, 2011
Last verified: March 2007

March 27, 2006
September 9, 2011
July 2005
July 2011   (final data collection date for primary outcome measure)
Number of side effects (morbidity) [ Time Frame: at 3 years ] [ Designated as safety issue: No ]
  • the number of side effects at 3 years (morbidity)
  • The primary end point is:
Complete list of historical versions of study NCT00307671 on ClinicalTrials.gov Archive Site
  • Survival [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
  • Efficacy of treatment (remission rate) [ Time Frame: during the 3 years ] [ Designated as safety issue: Yes ]
  • Relapse rate [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
  • Cumulative dose exposure to OCS and AZA [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]
  • Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values [ Time Frame: at 3 years ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants

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.

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Vasculitis
  • Wegener's Granulomatosis
  • Microscopic Polyangiitis
  • Churg-Strauss Syndrome
  • Polyarteritis Nodosa
  • Drug: prednisone, methylprednisolone,cyclophosphamides
    treatment conventional
    Other Name: prednisone, methylprednisolone,cyclophosphamides
  • Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
    reduction dose
    Other Name: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
  • Drug: Mycophenolate mofetil,methotrexate
    in the treatment conventional and in the reduction dose
    Other Name: Mycophenolate mofetil,methotrexate
  • A
    conventional treatment
    Interventions:
    • Drug: prednisone, methylprednisolone,cyclophosphamides
    • Drug: Mycophenolate mofetil,methotrexate
  • Experimental: B
    reduction dose
    Interventions:
    • Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
    • Drug: Mycophenolate mofetil,methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00307671
P040425
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Loïc Guillevin, MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP