Millennium Begins Phase II RA Trial

Millennium Pharmaceuticals, Inc. initiated a randomized, double-blind, placebo-controlled Phase II study of MLN3897 in patients with rheumatoid arthritis (RA). MLN3897, an oral, small molecule designed to block CCR1, is a chemokine receptor believed to play a role in inflammatory disorders including RA.

The study will assess the efficacy, safety and tolerability of MLN3897 in combination with methotrexate (MTX), a standard therapy for RA. As many as 186 patients with RA that have been taking MTX for at least six months prior to screening will be enrolled in the study. Patients will continue the MTX regimen and will receive MLN3897 or placebo. The primary endpoint of the study is ACR20 response rate, a standard clinical measurement for RA, which measures improvement in the number of tender and swollen joints and various levels of disease activity.