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news.Biogen Idec, a US-based pharmaceutical company, has announced that its Phase II trial of baminercept in rheumatoid arthritis patients who have had an inadequate response to conventional therapy with a disease-modifying antirheumatic drug did not meet its primary endpoint.
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The primary endpoint was defined as the proportion of baminercept-treated patients who achieved an ACR50 response, a standard measure of disease improvement in rheumatoid arthritis (RA), compared to placebo at 14 weeks. The study also did not meet any of the pre-specified secondary endpoints.
Based on these results as well as preliminary data from a Phase II trial of baminercept in RA patients who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, the company has decided to discontinue the development of the compound in RA.
The 104RA202 study was a randomized, double-blind, placebo-controlled, multicenter, dose-finding Phase II trial involving 380 individuals with active RA who had an inadequate response to conventional disease-modifying antirheumatic drug (DMARD) therapy. The trial was designed to assess the efficacy of five different regimens of baminercept when administered over 12 weeks in combination with methotrexate within this patient population.