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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307671
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : September 12, 2011
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

March 27, 2006
March 28, 2006
September 12, 2011
July 2005
July 2011   (Final data collection date for primary outcome measure)
Number of side effects (morbidity) [ Time Frame: at 3 years ]
  • The primary end point is:
  • the number of side effects at 3 years (morbidity)
Complete list of historical versions of study NCT00307671 on Archive Site
  • 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 ]
  • 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
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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).

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Vasculitis
  • Wegener's Granulomatosis
  • Microscopic Polyangiitis
  • Churg-Strauss Syndrome
  • Polyarteritis Nodosa
  • Drug: prednisone, methylprednisolone,cyclophosphamides
    treatment conventional
  • Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
    reduction dose
  • Drug: Mycophenolate mofetil,methotrexate
    in the treatment conventional and in the reduction dose
  • A
    conventional treatment
    • Drug: prednisone, methylprednisolone,cyclophosphamides
    • Drug: Mycophenolate mofetil,methotrexate
  • Experimental: B
    reduction dose
    • Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
    • Drug: Mycophenolate mofetil,methotrexate
Pagnoux C, Quéméneur T, Ninet J, Diot E, Kyndt X, de Wazières B, Reny JL, Puéchal X, le Berruyer PY, Lidove O, Vanhille P, Godmer P, Fain O, Blockmans D, Bienvenu B, Rollot F, Aït el Ghaz-Poignant S, Mahr A, Cohen P, Mouthon L, Perrodeau E, Ravaud P, Guillevin L; French Vasculitis Study Group. Treatment of systemic necrotizing vasculitides in patients aged sixty-five years or older: results of a multicenter, open-label, randomized controlled trial of corticosteroid and cyclophosphamide-based induction therapy. Arthritis Rheumatol. 2015 Apr;67(4):1117-27. doi: 10.1002/art.39011.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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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