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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
A
conventional treatment
Drug: prednisone, methylprednisolone,cyclophosphamides
treatment conventional
Other Name: prednisone, methylprednisolone,cyclophosphamides
Drug: Mycophenolate mofetil,methotrexate
in the treatment conventional and in the reduction dose
Other Name: Mycophenolate mofetil,methotrexate
Experimental: B
reduction dose
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

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).

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307671

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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00307671     History of Changes
Other Study ID Numbers: P040425
Study First Received: March 27, 2006
Last Updated: September 9, 2011
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Churg-Strauss Syndrome
Polyarteritis Nodosa
Vasculitis
Wegener Granulomatosis
Systemic Vasculitis
Microscopic Polyangiitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vascular Diseases
Cardiovascular Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Autoimmune Diseases
Immune System Diseases
Arteritis
Skin Diseases, Vascular
Skin Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Azathioprine
Methotrexate
Cyclophosphamide
Immunosuppressive Agents
Mycophenolate mofetil
Methylprednisolone Hemisuccinate
Prednisolone
Mycophenolic Acid
Prednisone
Methylprednisolone acetate

ClinicalTrials.gov processed this record on April 15, 2014