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| ID | Type | Description | Link |
|---|---|---|---|
| UMCG-ANCA-MMF-1 |
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The purpose of this study is to determine the efficacy and safety of a new drug, mycophenolate mofetil, for the treatment of relapses of ANCA-associated vasculitis (Wegener's granulomatosis or microscopic polyangiitis). Therefore, we compare the standard therapy with cyclophosphamide to mycophenolate mofetil.
The investigators expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide.
Treatment of ANCA-associated vasculitis consists of two phases: remission induction with highly effective, but also relatively toxic drugs, and, secondly, after remission is achieved, maintenance therapy with less toxic drugs. The standard induction therapy of a relapse of Wegener's granulomatosis or microscopic polyangiitis consists of the combination of cyclophosphamide and prednisolone. Although this induction therapy is very effective, it is very toxic as well.
Searching for an alternative for cyclophosphamide, we will test the efficacy and safety of a new combination therapy with mycophenolate mofetil and prednisolone. We will compare the effect and safety of the standard induction therapy with the new therapy. When relapses occur, patients will be randomized for either the standard therapy with cyclophosphamide or for mycophenolate mofetil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 MMF induction | Experimental | mycophenolate and steroids as remission induction, followed by azathioprine as maintenance therapy |
|
| 2 CYC induction | Active Comparator | cyclophosphamide and steroids, followed by maintenance therapy (azathioprine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mycophenolate mofetil | Drug | 2000 mg mycophenolate mofetil per day combined with steroids for induction remission, followed by azathioprine standard maintenance therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| remission induction rate | 6 months | |
| disease free survival after 2 and 4 years | 2 and 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| time to remission | 9 months | |
| cumulative organ damage | 4 years | |
| side-effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Coen Stegeman, MD PhD | UMCG Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Groningen | Groningen | 9700 RB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Stegeman CA; Cohen Tervaert JW. Mycophenolate mofetil for remission induction in patients with active Wegener's Granulomatosis (WG) intolerant for cyclophosphamide. J Am Soc Nephrol(11):98A, 2000 |
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| ID | Term |
|---|---|
| D014890 | Granulomatosis with Polyangiitis |
| D014657 | Vasculitis |
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D055953 | Microscopic Polyangiitis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056647 | Systemic Vasculitis |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| cyclophosphamide | Drug | 2 mg/kg/d, combined with steroids, for remission induction, followed by standard azathioprine maintenance therapy |
|
| 4 years |
| ANCA titres over time | 4 years |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| 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 |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |