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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00307671
Date of registration: 27/03/2006
Prospective Registration: No
Primary sponsor: Assistance Publique - Hôpitaux de Paris
Public title: Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years CORTAGE
Scientific title: Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants
Date of first enrolment: July 2005
Target sample size: 108
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00307671
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
France
Contacts
Name:     Loïc Guillevin, MD,PhD
Address: 
Telephone:
Email:
Affiliation:  Assistance Publique - Hôpitaux de Paris
Key inclusion & exclusion 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



Age minimum: 65 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Churg-Strauss Syndrome
Microscopic Polyangiitis
Polyarteritis Nodosa
Vasculitis
Wegener's Granulomatosis
Intervention(s)
Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
Drug: Mycophenolate mofetil,methotrexate
Drug: prednisone, methylprednisolone,cyclophosphamides
Primary Outcome(s)
Number of side effects (morbidity) [Time Frame: at 3 years]
Secondary Outcome(s)
Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values [Time Frame: at 3 years]
Cumulative dose exposure to OCS and AZA [Time Frame: at 3 years]
Efficacy of treatment (remission rate) [Time Frame: during the 3 years]
Relapse rate [Time Frame: at 3 years]
Survival [Time Frame: at 3 years]
Secondary ID(s)
P040425
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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