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

Primary Purpose

Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
prednisone, methylprednisolone,cyclophosphamides
Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
Mycophenolate mofetil,methotrexate
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasculitis focused on measuring Systemic necrotizing vasculitides, corticosteroids; azathioprine; mycophenolate mofetil;, cyclophosphamide, Elderly patients, Randomized controlled trial

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Cochin

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

A

B

Arm Description

conventional treatment

reduction dose

Outcomes

Primary Outcome Measures

Number of side effects (morbidity)

Secondary Outcome Measures

Survival
Efficacy of treatment (remission rate)
Relapse rate
Cumulative dose exposure to OCS and AZA
Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values

Full Information

First Posted
March 27, 2006
Last Updated
September 9, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00307671
Brief Title
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years
Acronym
CORTAGE
Official Title
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa
Keywords
Systemic necrotizing vasculitides, corticosteroids; azathioprine; mycophenolate mofetil;, cyclophosphamide, Elderly patients, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
conventional treatment
Arm Title
B
Arm Type
Experimental
Arm Description
reduction dose
Intervention Type
Drug
Intervention Name(s)
prednisone, methylprednisolone,cyclophosphamides
Intervention Description
treatment conventional
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
Intervention Description
reduction dose
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil,methotrexate
Intervention Description
in the treatment conventional and in the reduction dose
Primary Outcome Measure Information:
Title
Number of side effects (morbidity)
Time Frame
at 3 years
Secondary Outcome Measure Information:
Title
Survival
Time Frame
at 3 years
Title
Efficacy of treatment (remission rate)
Time Frame
during the 3 years
Title
Relapse rate
Time Frame
at 3 years
Title
Cumulative dose exposure to OCS and AZA
Time Frame
at 3 years
Title
Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values
Time Frame
at 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc Guillevin, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75679
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25693055
Citation
Pagnoux C, Quemeneur T, Ninet J, Diot E, Kyndt X, de Wazieres B, Reny JL, Puechal X, le Berruyer PY, Lidove O, Vanhille P, Godmer P, Fain O, Blockmans D, Bienvenu B, Rollot F, Ait el Ghaz-Poignant S, Mahr A, Cohen P, Mouthon L, Perrodeau E, Ravaud P, Guillevin L; French Vasculitis Study Group. Treatment of systemic necrotizing vasculitides in patients aged sixty-five years or older: results of a multicenter, open-label, randomized controlled trial of corticosteroid and cyclophosphamide-based induction therapy. Arthritis Rheumatol. 2015 Apr;67(4):1117-27. doi: 10.1002/art.39011.
Results Reference
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Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years

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