197
Participants
Start Date
January 31, 2005
Primary Completion Date
December 31, 2008
Study Completion Date
January 31, 2010
Rituximab plus cyclophosphamide placebo (rituximab group)
375 mg/m\^2 infusions once weekly for 4 week
Cyclophosphamide plus rituximab placebo (control group)
2 mg/kg/day orally for months 1-3
Azathioprine
2 mg/kg/day orally for months 4-6
Methylprednisolone (or other glucocorticoid)
1 g/day intravenously for up to 3 days within 14 days prior to receiving rituximab
Prednisone
During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit.
Hospital for Special Surgery, New York
Johns Hopkins University, Baltimore
Duke University, Durham
University of Alabama, Birmingham
The Cleveland Clinic, Cleveland
Mayo Clinic Foundation, Rochester
Boston University, Boston
University Hospital Groningen, Groningen
Collaborators (1)
Immune Tolerance Network (ITN)
NETWORK
Genentech, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH