A Phase III trial has found that combining Genentech and Biogen Idec’s humanized anti-CD20 antibody ocrelizumab with methotrexate effectively reduces the signs and symptoms of rheumatoid arthritis in sero-positive patients who previously demonstrated inadequate responses to methotrexate alone.
The companies say the international Phase III STAGE trial was the first to evaluate ocrelizumab in combination with methotrexate in this population of patients. The co-primary endpoint was an improvement in the signs and symptoms of RA at week 24 and week 28 in comparison with methotrexate monotherapy.
Results from three additional Phase III trials evaluating ocrelizumab in rheumatoid arthritis patients are due during the first half of 2010. Data from a Phase III trial evaluating ocrelizumab in patients with lupus nephritis are expected in 2011.
In June an arbitration panel ruled on a dispute between Genentech and Biogen Idec, relating to decision-making rights and other disagreements for anti-CD20 products covered by the companies’ collaboration agreement, including Rituxan, which Biogen Idec co-promotes in the U.S.