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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | conventional treatment |
|
| B | Experimental | reduction dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisone, methylprednisolone,cyclophosphamides | Drug | treatment conventional |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of side effects (morbidity) | at 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | at 3 years | |
| Efficacy of treatment (remission rate) | during the 3 years | |
| Relapse rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loïc Guillevin, MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin | Paris | 75679 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25693055 | Derived | 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. |
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| Cyclophosphamide, Azathioprine,prednisone,methylprednisolone |
| Drug |
reduction dose |
|
| Mycophenolate mofetil,methotrexate | Drug | in the treatment conventional and in the reduction dose |
|
| at 3 years |
| Cumulative dose exposure to OCS and AZA | at 3 years |
| Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values | at 3 years |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014890 | Granulomatosis with Polyangiitis |
| D055953 | Microscopic Polyangiitis |
| D015267 | Churg-Strauss Syndrome |
| D010488 | Polyarteritis Nodosa |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D056647 | Systemic Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D059345 | Cerebral Small Vessel Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006099 | Granuloma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001167 | Arteritis |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D008775 | Methylprednisolone |
| D003520 | Cyclophosphamide |
| D001379 | Azathioprine |
| D009173 | Mycophenolic Acid |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
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