Switzerland’s Roche says that Actemra, a treatment for patients with moderate to severe rheumatoid arthritis who have an inadequate response to treatment with methotrexate, has met its primary endpoint in a major Phase III study.
The study of Actemra (tocilizumab), the first multinational Phase III trial of the drug, entered 623 patients with moderate to severe RA and in this three-arm, randomised, double-blind study, they received Actemra intravenously (either 4mg/kg or 8mg/kg) every four weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly.
The study found that patients treated with Actemra had a significant reduction in the signs and symptoms of the condition over six months of treatment and preliminary analysis did not reveal any clinically important safety concerns compared to control.
William Burns, chief executive of Roche Pharmaceuticals said the firm was pleased that the study confirms the favourable efficacy and safety profile of the drug, adding that “Actemra, through its unique blockade of the interleukin-6 receptor, will provide a new treatment option for people afflicted by RA." The company noted that four other Phase III trials exploring the treatment in RA are ongoing with three of them scheduled to report in 2007.
In Japan, Actemra was launched in June 2005 as a therapy for Castleman's disease and in April 2006 it was filed in the same country for the additional indications of RA and systemic-onset juvenile idiopathic arthritis.
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