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news.Trubion Pharmaceuticals has announced that its partner, Wyeth Pharmaceuticals, a division of Wyeth has commenced patient dosing in the next Phase IIb clinical trial of TRU-015 in patients with rheumatoid arthritis.
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The randomized, parallel, double-blind, placebo-controlled, dose regimen-finding study will evaluate the safety and efficacy of two dosing regimens administered to approximately 216 patients with active, seropositive rheumatoid arthritis (RA) on a background of methotrexate.
The primary outcome measurement for the TRU-015 Phase IIb study will be the American College of Rheumatology (ACR) 50 response measured at 24 weeks. Secondary outcome measurements will be ACR 20 and 70 and DAS-28 responses.
Peter Thompson, president, CEO and chairman of Trubion, said: “This study is designed to help us identify an induction, or initial, dosing regimen and allow us to further establish the most effective treatment regimen for TRU-015. We believe this study has been designed in a way that could support a registration package, and we look forward to the results of this evaluation.”