42
Participants
Start Date
August 31, 2005
Primary Completion Date
February 28, 2009
Study Completion Date
February 28, 2009
folate
Minimum of 1 mg/day oral (or folinic acid 5 mg/week)
methotrexate
15-25 mg/week oral or parenteral (10-14 mg/week if intolerant)
methylprednisolone
100 mg intravenous (IV) prior to each rituximab infusion (For Arm B, for the Months 6 and 18 cycles, IV saline was administered prior to each placebo infusion)
Placebo
To maintain the blind, patients in Arm B (Rituximab 1000 mg) received placebo infusions at Months 6 and 18.
Rituximab
500 mg or 1000 mg IV\*2.
Lead Sponsor
Genentech, Inc.
INDUSTRY