Fourth ACTEMRA™ (tocilizumab) Phase III Study Demonstrates Significant Clinical Benefit in RA Patients

Roche today announced that results from the AMBITION (Actemra versus Methotrexate double-Blind Investigative Trial In mONotherapy) trial, the fourth multinational Phase III study of ACTEMRA™, not only successfully met its primary endpoint of non-inferiority in patients with moderate to severe rheumatoid arthritis (RA), but also demonstrated superiority over the standard effective dose regimen of methotrexate alone.

AMBITION is the first multinational Phase III study to examine ACTEMRA monotherapy against methotrexate in RA patients who have not been treated with methotrexate within 6 months and have not discontinued methotrexate at any time due to toxicity or lack of efficacy. Results from this study – together with data from the three previous studies – will form the basis of the regulatory filing for marketing approval later this year.



“This first multinational Phase III study evaluating the safety and efficacy of ACTEMRA alone against methotrexate clearly demonstrates that ACTEMRA monotherapy successfully reduces the signs and symptoms of RA. Furthermore, it reinforces the important need to inhibit the interleukin-6 receptors that are involved in the inflammatory process of this devastating disease,” said Lars Birgerson, M.D., Ph.D., Global Head Medical Affairs, Roche.



The trial showed that a significantly greater proportion of patients treated with ACTEMRA (8 mg/kg) achieved a significant reduction in the signs and symptoms of RA as evaluated by ACR20 following 24 weeks of treatment. The study analysis included 673 patients from 252 trial sites in 18 countries, including the United States. ACTEMRA was generally well tolerated; the most common adverse events reported more frequently in the ACTEMRA arm of the AMBITION trial were upper respiratory tract infections, headache and nasopharyngitis.