Genentech/Biogen's ocrelizumab meets primary endpoints in first Ph III Trial in RA

US biotechnology major Genentech, a wholly owned subsidiary of Switzerland's Roche, and Biogen Idec have revealed results form a Phase III study (STAGE) of the investigational humanized anti-CD20 monoclonal antibody ocrelizumab given in combination with methotrexate (MTX) met its primary endpoint of improving signs and symptoms (as measured by American College of Rheumatology or ACR20 response) in rheumatoid arthritis (RA) patients who had an inadequate response to MTX at both 24 and 48 weeks. Genentech and Biogen Idec continue to analyze the study results and plan to submit the data for presentation at an upcoming medical meeting.

'These results are significant because they are the first data from a large Phase III trial to show that a humanized antibody targeted at B-cells improves the signs and symptoms of rheumatoid arthritis,' said Hal Barron, executive vice president, Global Development and chief medical officer at Genentech. 'These results build on earlier findings from our broad clinical program aimed at developing medicines to help people living with rheumatoid arthritis.'