Roche and Biogen Idec have suspended trials of ocrelizumab treatment in patients with rheumatoid arthritis due to safety
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■ Roche and Biogen Idec have suspended trials of ocrelizumab treatment in patients with rheumatoid arthritis due to safety concerns, they have announced. The suspension of such treatment was recommended by the Data and Safety Monitoring Board, which reviewed trials of ocrelizumab in patients with rheumatoid arthritis (SCRIPT, FEATURE, FILM and STAGE trials) and in patients with lupus (BELONG and BEGIN trials). The review uncovered an infectionrelated safety signal that "included serious and opportunistic infections, some of which were fatal". Both FILM and BELONG trials had previously been halted for safety reasons. Roche. Roche and Biogen Idec decide to suspend Ocrelizumab treatment Rheumatoid Arthritis development programme on hold. Media Release : 8 Mar 809110259 2010. Available from: URL: http://www.roche.com
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Reactions 13 Mar 2010 No. 1292
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