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Actemra (tocilizumab) Third Phase III Study Results Show,Significant Improvement in Symptoms of Patients with Rheumatoid,Arthritis

designed to evaluate the safety and efficacy of ACTEMRA plus methotrexate (4 mg/kg or 8 mg/kg) compared to placebo plus methotrexate in RA patients who had an inadequate response to anti-TNFs alone. Patients received either ACTEMRA intravenously (4 mg/kg or 8 mg/kg) every four weeks plus methotrexate weekly or placebo infusions every four weeks plus methotrexate weekly.

Data from the study were analyzed to determine patients' response to treatment by using three standard assessments: ACR score (1), developed by the of Rheumatology (ACR), DAS28 (2), a measurement of RA disease activity, and EULAR response criteria (3), a measurement of treatment response. The study included 498 patients at 128 trial sites in 13 countries, including the United States.

The RADIATE trial is one of five Phase III clinical studies designed to investigate ACTEMRA as a potential new treatment for RA. Roche and Chugai have initiated the collaborative clinical development program that has enrolled a total of more than 4,000 patients in 41 countries including the United States and several European countries.

About ACTEMRA (tocilizumab)

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA. Studies suggest that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, may reduce inflammation of the joints. The global ACTEMRA Phase III clinical development program is designed to evaluate this clinical finding. The compound is not currently approved in the United States.

The most common adverse events reported in ACTEMRA global clinical studies are upper respiratory tract infections, headache, nasopharyngitis and hypertension. As with other biological disease modifying anti-rheumatic drugs (DMARDs), serious infections have been reported in some patients treated with ACTEMRA.

About Rheumatoid Arthritis

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