The remission-induction period was 6 months. The rituximab group received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo–cyclophosphamide. The control group received placebo–rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Patients in the control group who had a remission between 3 and 6 months were eligible to switch from cyclophosphamide to azathioprine (2 mg per kilogram per day).10 (link) Patients in the rituximab group with a remission during the same 3-to-6-month period were switched from placebo–cyclophosphamide to placebo–azathioprine.
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 Supplementary Appendix).