Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years
NCT ID: NCT00307671
Last Updated: 2011-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
108 participants
INTERVENTIONAL
2005-07-31
2011-07-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
conventional treatment
prednisone, methylprednisolone,cyclophosphamides
treatment conventional
Mycophenolate mofetil,methotrexate
in the treatment conventional and in the reduction dose
B
reduction dose
Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
reduction dose
Mycophenolate mofetil,methotrexate
in the treatment conventional and in the reduction dose
Interventions
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prednisone, methylprednisolone,cyclophosphamides
treatment conventional
Cyclophosphamide, Azathioprine,prednisone,methylprednisolone
reduction dose
Mycophenolate mofetil,methotrexate
in the treatment conventional and in the reduction dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Loïc Guillevin, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Cochin
Paris, , France
Countries
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References
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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.
Other Identifiers
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P040425
Identifier Type: -
Identifier Source: org_study_id
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