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

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ClinicalTrials.gov Identifier: NCT00307671
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : September 12, 2011
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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 or disease Intervention/treatment 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

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
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
Study Start Date : July 2005
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011


Arm Intervention/treatment
A
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




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

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00307671     History of Changes
Other Study ID Numbers: P040425
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: September 12, 2011
Last Verified: March 2007

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:
Vasculitis
Systemic Vasculitis
Churg-Strauss Syndrome
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Immune System Diseases
Central Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Agents
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Polyarteritis Nodosa
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Autoimmune Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Arteritis
Skin Diseases, Vascular
Skin Diseases
Cyclophosphamide
Methotrexate
Azathioprine
Prednisone