Actemra Phase III Trial Meets RA Endpoint

Roche’s Phase III Actemra RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) trial met its primary endpoint in patients with moderate to severe rheumatoid arthritis (RA) who failed to respond to anti-tumor necrosis factor treatments (anti-TNFs).

The third multinational Phase III study of Actemra showed that more patients treated with Actemra plus methotrexate achieved a significant reduction in the signs and symptoms of RA as evaluated by ACR20 following 24 weeks of treatment, compared to those who were treated with placebo plus methotrexate.

Actemra was generally well tolerated. The most common adverse events reported more frequently in the Actemra arms of the trial were nausea, headache, nasopharyngitis, diarrhea and upper respiratory tract infection.

Additional Phase III trials exploring Actemra in RA are ongoing with another study scheduled to report in 2007.