IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis

18:23 EDT 29th May 2015 | BioPortfolio

Summary

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

Description

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 Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

ANCA Associated Systemic Vasculitis Including Wegener’s

Intervention

Cyclophosphamide, Mycophenolate mofetil, Azathioprine, Prednisone (and methylprednisolone)

Location

Hopital Cochin
Paris
France
75679

Status

Terminated

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

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Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis

The purpose of this study is to investigate whether mycophenolate mofetil is effective as treatment for new cases of ANCA associated vasculitis.

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Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid

To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid.

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The purpose of this study is to determine whether Infliximab (monoclonal anti-tumour necrosis factor alpha antibodies) are safe and effective in the treatment of anti-neutrophil cytoplasm ...

A Study of CellCept (Mycophenolate Mofetil) in Management of Patients With Lupus Nephritis.

This 2 arm study will assess the efficacy of CellCept compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of CellCept compared ...

PubMed Articles [486 Associated PubMed Articles listed on BioPortfolio]

Is Mycophenolate Mofetil an Alternative Agent to Corticosteroids in Traumatic Nerve Paralysis?

The effects of an immunosuppressive agent, mycophenolate mofetil (MM), were investigated and compared with those of methylprednisolone (MP) and dexamethasone (DXM) on the traumatic nerve function.

Differential effects of cyclophosphamide and mycophenolate mofetil on cellular and serological parameters in patients with systemic lupus erythematosus.

Disease activity and therapy show an impact on cellular and serological parameters in patients with systemic lupus erythematosus (SLE). This study was performed to compare the influence of mycophenola...

Rituximab or Azathioprine Maintenance in ANCA-Associated Vasculitis.

To the Editor: In their article on the Maintenance of Remission using Rituximab in Systemic ANCA-associated Vasculitis (MAINRITSAN) trial, Guillevin and colleagues (Nov. 6 issue)(1) report that rituxi...

Rituximab or Azathioprine Maintenance in ANCA-Associated Vasculitis.

To the Editor: In their article on the Maintenance of Remission using Rituximab in Systemic ANCA-associated Vasculitis (MAINRITSAN) trial, Guillevin and colleagues (Nov. 6 issue)(1) report that rituxi...

Rituximab or Azathioprine Maintenance in ANCA-Associated Vasculitis.

To the Editor: In their article on the Maintenance of Remission using Rituximab in Systemic ANCA-associated Vasculitis (MAINRITSAN) trial, Guillevin and colleagues (Nov. 6 issue)(1) report that rituxi...

Medical and Biotech [MESH] Definitions

Autoantibodies directed against cytoplasmic constituents of POLYMORPHONUCLEAR LEUKOCYTES and/or MONOCYTES. They are used as specific markers for WEGENER GRANULOMATOSIS and other diseases, though their pathophysiological role is not clear. ANCA are routinely detected by indirect immunofluorescence with three different patterns: c-ANCA (cytoplasmic), p-ANCA (perinuclear), and atypical ANCA.

An immunosuppressive agent used in combination with cyclophosphamide and hydroxychloroquine in the treatment of rheumatoid arthritis. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), this substance has been listed as a known carcinogen. (Merck Index, 11th ed)

A water-soluble ester of METHYLPREDNISOLONE used for cardiac, allergic, and hypoxic emergencies.

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

A PREDNISOLONE derivative with similar anti-inflammatory action.

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