Ocrelizumab Trial Halted
Biogen, Roche report safety risks outweigh benefits
Wednesday, March 10, 2010
Press release from Biogen Idec:
Roche and Biogen Idec announced today their decision to suspend Ocrelizumab treatment of patients in the Rheumatoid Arthritis (RA) programme. The decision follows the recommendation of the independent Ocrelizumab RA & Lupus Data and Safety Monitoring Board (DSMB) based on their assessment of the studies in RA (SCRIPT, FEATURE, FILM and STAGE) and lupus (BELONG and BEGIN).
The DSMB concluded that the safety risk outweighs the benefits observed in these specific patient populations at this time. The DSMB review detected an infection related safety signal which included serious and opportunistic infections, some of which were fatal.
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