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

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

Condition Intervention Phase
Vasculitis Wegener's Granulomatosis Microscopic Polyangiitis Churg-Strauss Syndrome Polyarteritis Nodosa Drug: prednisone, methylprednisolone,cyclophosphamides Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone Drug: Mycophenolate mofetil,methotrexate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 108
Study Start Date: July 2005
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
conventional treatment
Drug: prednisone, methylprednisolone,cyclophosphamides
treatment conventional
Drug: Mycophenolate mofetil,methotrexate
in the treatment conventional and in the reduction dose
Experimental: B
reduction dose
Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
reduction dose
Drug: Mycophenolate mofetil,methotrexate
in the treatment conventional and in the reduction dose

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).


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00307671

Hôpital Cochin
Paris, France, 75679
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Loïc Guillevin, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00307671     History of Changes
Other Study ID Numbers: P040425
Study First Received: March 27, 2006
Last Updated: September 9, 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Systemic necrotizing vasculitides
corticosteroids; azathioprine; mycophenolate mofetil;
Elderly patients
Randomized controlled trial

Additional relevant MeSH terms:
Polyarteritis Nodosa
Systemic Vasculitis
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Churg-Strauss Syndrome
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Mycophenolate mofetil
Prednisone processed this record on September 21, 2017