Hoffmann-La Roche Inc (NUTLEY, New Jersey) announced that the Actemraâ„¢ RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) trial successfully met its primary endpoint in patients with moderate-to-severe active rheumatoid arthritis (RA) who failed to respond to at least one anti-TNF therapy. The third multinational phase III trial, outside of Japan, evaluated the safety and efficacy of Actemra plus methotrexate (MTX) compared with placebo plus MTX. The study showed that a greater proportion of patients treated with Actemra plus MTX achieved a significant reduction in the signs and symptoms of RA as evaluated by ACR20 following 24 weeks of treatment. Actemra is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody.
The three-arm, randomized, double-blind, placebo-controlled study involved 498 patients at 128 trial sites in 13 countries including the US. Patients received either Actemra intravenously (4 mg/kg or 8 mg/kg) every 4 weeks plus MTX (10-25 mg) weekly or placebo infusions every 4 weeks plus MTX weekly. Data from this trial will be submitted for presentation at future international scientific meetings.
The RADIATE trial is one of five phase III clinical studies that will investigate Actemra as a potential new treatment for RA. Roche and Chugai Pharmaceutical Co, Ltd have initiated the collaborative clinical development program that has enrolled more than 4000 patients in 41 countries including the US and several European countries. Roche's global Actemra phase III program includes two additonal studies now under way, one of which is scheduled to conclude in 2007. Roche plans to file Actemra for regulatory approval in the US and in Europe in the fourth quarter of 2007.
Actemra is currently marketed in Japan under the trade name "ACTEMRA® 200 for Intravenous Infusion" after approval as a therapy for Castleman's disease in April 2005. In April 2006, Roche filed in Japan for additional indications for RA and systemic-onset juvenile idiopathic arthritis.
—A. Techman
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