54
Participants
Start Date
May 31, 2006
Primary Completion Date
April 30, 2009
Study Completion Date
July 31, 2011
IDEC-C2B8 (rituximab)
Participants will receive 500 mg rituximab on Day 1 and Day 15
Placebo
Participants will receive placebo on Day 1 and Day 15
Methotrexate
Participants must have been treated with MTX ≥15 mg per week and ≤25 mg per week (dose may have been as low as 10 mg if unable to tolerate higher dose) for at least 12 weeks immediately prior to Day 1, at a stable dose for at least 4 weeks and was continued for the study duration.
Etanercept
Participants must have been treated with etanercept at 50 mg per week (25 mg twice per week or 50 mg once per week).
Adalimumab
Participants must have been treated with adalimumab at 40 mg every other week for at least 12 weeks immediately prior to Day 1.
Methylprednisolone
Methylprednisolone 100 mg IV was administered by slow infusion to be completed at least 30 minutes prior to each infusion of rituximab or placebo.
Folate
All subjects also received a stable dose of folate (≥5 mg per week).
Research Site, Duncansville
Research Site, Jupiter
Research Site, Sarasota
Research Site, Huntsville
Research site, Chardon
Research Site, Mayfield Village
Research Site, Kalamazoo
Research Site, St Louis
Research Site, Oklahoma City
Research Site, Tulsa
Research Site, Dallas
Research Site, Houston
Research Site, San Antonio
Research Site, Boise
Research Site, Salt Lake City
Research Site, Paradise Valley
Research Site, Palm Desert
Research Site, Burlington
Lead Sponsor
Collaborators (1)
Hoffmann-La Roche
INDUSTRY
Genentech, Inc.
INDUSTRY
Biogen
INDUSTRY