Renal Limited Vasculitis Clinical Trial
Official title:
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis
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.
HYPOTHESIS :
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00753103 -
Anti-Cytokine Therapy for Vasculitis
|
Phase 2 |