CellCept
Since our Roche partnership began in October 2003, Aspreva's clinical research team has initiated three phase III clinical trials evaluating MMF for:
Myasthenia gravis- Complete
For further information about trial sites and patient recruitment, please visit www.clinicaltrials.gov
Lupus nephritis (LN)
Aspreva Partner
F. Hoffmann-La Roche Ltd
Product Name
CellCept
Generic Name
Mycophenolate Mofetil (MMF)
Approved Indications
The prevention of rejection of kidney, heart, and liver transplants.
Clinical Study Summary
Aspreva's Lupus Management Study (ALMS) is one of the largest phase III studies conducted in lupus nephritis.
The two-stage induction and maintenance study is a randomized open label comparison of MMF with the current standard of care, intravenous cyclophosphamide for the first six months, followed by a double-blind comparison of MMF to azathioprine for up to three years. This study will assess the efficacy and safety of MMF in inducing response and maintaining remission in patients with lupus nephritis.
The two-stage induction and maintenance study is a randomized open label comparison of MMF with the current standard of care, intravenous cyclophosphamide for the first six months, followed by a double-blind comparison of MMF to azathioprine for up to three years. This study will assess the efficacy and safety of MMF in inducing response and maintaining remission in patients with lupus nephritis.
Primary Endpoint
The primary endpoint for the induction phase can be summarized as an improvement in proteinuria, normalization of serum creatinine as well as the absence of hematuria.
Phase of Development
Phase III
Trial Initiation (first patient enrolled)
July 2005
Anticipated Completion of Trial
Induction phase - early 2007
Myasthenia gravis (MG)
Aspreva Partner
F. Hoffmann-La Roche Ltd
Product Name
CellCept
Generic Name
Mycophenolate Mofetil (MMF)
Approved Indications
The prevention of rejection of kidney, heart and liver transplants.
Clinical Study Summary
Randomized, double-blind placebo controlled clinical trial designed to investigate the efficacy and safety of CellCept for patients with myasthenia gravis over a treatment period of 36 weeks.
Primary Endpoint
The primary endpoint of responder status encompasses both minimal disease activity and low steroid dose.
Phase of Development
Phase III
Trial Initiation (first patient enrolled)
April 2004
Trial Complete
Failed to meet both primary and secondary endpoints.
Pemphigus vulgaris (PV)
Aspreva Partner
F. Hoffmann-La Roche Ltd
Generic Name
Mycophenolate Mofetil (MMF)
Approved Indications
The prevention of rejection of kidney, heart and liver transplants.
Clinical Study Summary
Randomized, double-blind, placebo controlled comparison study of MMF and placebo to investigate the efficacy and safety of MMF for patients with pemphigus vulgaris over a treatment period of 52 weeks.
Primary Endpoint
Primary end point encompasses both minimal disease activity, defined as no new persistent lesions, together with a low steroid dose.
Phase of Development
Phase III
Trial Initiation (first patient enrolled)
June 2004
Anticipated Completion of Trial
2008
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