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

September 9, 2011 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75679
        • Hopital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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: Mycophenolate mofetil,methotrexate
in the treatment conventional and in the reduction dose
Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
reduction dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of side effects (morbidity)
Time Frame: at 3 years
at 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: at 3 years
at 3 years
Efficacy of treatment (remission rate)
Time Frame: during the 3 years
during the 3 years
Relapse rate
Time Frame: at 3 years
at 3 years
Cumulative dose exposure to OCS and AZA
Time Frame: at 3 years
at 3 years
Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values
Time Frame: at 3 years
at 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Loïc GUILLEVIN, MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 28, 2006

Study Record Updates

Last Update Posted (Estimate)

September 12, 2011

Last Update Submitted That Met QC Criteria

September 9, 2011

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P040425

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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