Trubion, Wyeth Report Preliminary Results With TRU-015

Trubion Pharmaceuticals and Wyeth Pharmaceuticals announced results from a Phase IIb randomized, double-blind, placebo-controlled, multicenter clinical trial of its TRU-015 for the treatment of rheumatoid arthritis.

The trial included 276 patients with rheumatoid arthritis who also were receiving methotrexate as background therapy. Patients in the study were randomized into five groups that received 200, 400, 800 or 1,600 mg of TRU-015 or placebo.

TRU-015 administered as a single dose was generally well tolerated, and only one subject in the 400-mg group experienced a grade 3 adverse event on the day of infusion.

The results indicated that TRU-015 provided statistically significant improvements in rheumatoid arthritis signs and symptoms compared with placebo at 24 weeks, Trubion and Wyeth said.