IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis
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|ClinicalTrials.gov Identifier: NCT00307645|
Recruitment Status : Terminated
First Posted : March 28, 2006
Last Update Posted : April 10, 2006
The aim of IMPROVE is to define the optimal maintenance therapy for ANCA-associated vasculitides (AASV) by comparing the AZA (standard regimen) with MMF in terms of efficacy, i.e. in preventing relapses.
MMF might be more effective than azathioprine as maintenance drug in AASV patients, reducing by 50% relapse rate, with a same frequency of adverse effects
|Condition or disease||Intervention/treatment||Phase|
|ANCA Associated Systemic Vasculitis Including Wegener’s Granulomatosis and Microscopic Polyangiitis and Renal Limited Vasculitis||Drug: Cyclophosphamide Drug: Mycophenolate mofetil Drug: Azathioprine Drug: Prednisone (and methylprednisolone)||Phase 3|
AASV, including Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA) and renal limited vasculitis (RLV), are progressive, multisystem, autoimmune diseases which require the prescription of immunosuppressive therapy. Treatment using corticosteroids and cytotoxic drugs has been standardised (ECSYSVASTRIAL project), but relapse rate remains high and treatment-related toxicity is non negligible. The IMPROVE trial aims to reduce this relapse rate by using mycophenolate mofetil (MMF) for maintenance therapy. The potential benefit of MMF has been suggested in a published open and uncontrolled study. Patients with newly diagnosed systemic AASV will be randomly assigned to receive either MMF or reference treatment with azathioprine (AZA), once remission has been obtained with cyclophosphamide and prednisone. MMF and AZA will be continued for a total of 42 months of therapy with concomitant prednisone dose tapering. The study will last 48 months. Hence, within the last 6 months of the study duration, the patients will not receive any immunosuppressive drugs.
The primary end-point will the disease-free period, taken as the period of time from remission until relapse or study end; secondary end-points will be adverse events, cumulative damage (assessed using damage score VDI) and immunosuppressive drug cumulative dose.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis|
|Study Start Date :||May 2003|
|Estimated Study Completion Date :||August 2009|
- the disease-free period, defined as the time between the beginning
- of the maintenance therapy (AZA or MMF) and the first relapse (minor or major)
- or the end of the protocol (at 48 months)
- relapse rate
- rate of side-effects and intolerance
- cumulative doses (AZA, CS, MMF)
- AUC for BVAS, SF-36 or VDI
- Evolution of titers of ANCA and CRP
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307645
|Paris, France, 75679|
|Addenbrooke's Hospital - Departement of Medecine|
|Cambridge, United Kingdom, CB2 2SP|
|Principal Investigator:||Loïc GUILLEVIN, MD,PhD||Assistance Publique - Hôpitaux de Paris|