The two treatment groups received the same glucocorticoid regimen: one to three pulses of methylprednisolone (1000 mg each), followed by prednisone at a dose of 1 mg per kilogram per day. The dose was tapered so that by 5 months, all patients who had a remission without disease flares had discontinued glucocorticoids (see the
Rituximab vs. Cyclophosphamide in ANCA-Associated Vasculitis
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Corresponding Organization :
Other organizations : Massachusetts General Hospital, Boston University, University Medical Center, Boston Medical Center, Hospital for Special Surgery, Johns Hopkins University, Cleveland Clinic, University of Groningen, Duke University, University of Alabama at Birmingham, Immune Tolerance Network, National Institute of Allergy and Infectious Diseases, Mayo Clinic, United States Food and Drug Administration
Protocol cited in 10 other protocols
Variable analysis
- Treatment group: Rituximab plus placebo–cyclophosphamide
- Control group: Placebo–rituximab plus cyclophosphamide
- Remission status during the 3-to-6-month period
- Glucocorticoid regimen: One to three pulses of methylprednisolone (1000 mg each), followed by prednisone at a dose of 1 mg per kilogram per day, tapered to discontinuation by 5 months
- Positive control: Rituximab group
- Negative control: Placebo–rituximab group
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