Phase 3 Rituxan study fails to meet primary endpoint

Genentech and Biogen Idec announced that a Phase III study of Rituxan (rituximab) plus mycophenolate mofetil (MMF) and corticosteroids in patients with lupus nephritis did not meet its primary endpoint of significantly reducing disease activity at 52 weeks. The primary endpoint evaluated improvements in kidney response as measured by standard laboratory tests used to assess kidney health.

This Phase III randomized, double-blind, placebo-controlled, multi-center study included 144 patients with Class III or IV lupus nephritis from approximately 60 sites.  These patients were treated with mycophenolate mofetil (MMF) and corticosteroids and were randomized 1:1 to receive Rituxan or placebo in two infusions, 15 days apart. They were retreated six months later with the same regimen.  Patients were evaluated for efficacy at weeks 24 and 52. The majority of patients are being monitored for at least 78 weeks.

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