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

22:57 EDT 25th October 2014 | 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

Clinical Trials [1046 Associated Clinical Trials listed on BioPortfolio]

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.

Mycophenolate Mofetil in Membranous Nephropathy

Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment mod...

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.

Anti-Cytokine Therapy for Vasculitis

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 [524 Associated PubMed Articles listed on BioPortfolio]

Acute Colonic Pseudo-Obstruction Caused by Mycophenolate Mofetil in a Kidney Transplant Recipient.

Mycophenolate mofetil is a component of immunosuppressive regimens in solid-organ transplant recipients. Gastrointestinal symptoms such as nausea, abdominal pain, and diarrhea without fever are common...

Pharmacokinetics of Concentration-Controlled Mycophenolate Mofetil in Proliferative Lupus Nephritis: An Observational Cohort Study.

Mycophenolate mofetil (MMF) has variable pharmacokinetics. This study examines the pharmacokinetic and clinical correlations in proliferative lupus nephritis.

Switching treatment between mycophenolate mofetil and azathioprine in lupus patients: Indications and outcomes.

Objective: Our aim was to determine the reasons for changing treatment from mycophenolate mofetil (MMF) to azathioprine (AZA) or vice versa in lupus patients and to evaluate the effect of the change. ...

Treatment-refractory myasthenia gravis.

Myasthenia gravis (MG) is the most common disorder of neuromuscular transmission and is a prototypical autoimmune disorder. Most patients with MG are successfully treated with acetylcholinesterase inh...

Mycophenolate mofetil for relapsing-remitting multiple sclerosis.

Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system and a leading cause of disability in young and middle-aged adults. Mycophenolate mofetil (MMF) is an immunosuppressi...

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.

More From BioPortfolio on "IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis"

Search BioPortfolio:
Loading
Advertisement

Relevant Topics

Pharmacy
Latest News Clinical Trials Research Drugs Reports Corporate
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Nephrology - kidney function
Latest News Clinical Trials Research Drugs Reports Corporate
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...

Advertisement