Previous studies looking at the role of rituximab for the treatment of lupus nephritis have been criticized for poor design. Initial data from the RITUXILUP group (rituximab and IV methylprednisolone on days 1 and 15 with background MMF but no oral steroids) have been promising, but many patients cannot tolerate MMF, and the role of rituximab as monotherapy given over 6 month intervals remains uncertain. RoRo-LuN would randomize patients with biopsy proven WHO class III or IV lupus nephritis to one of three arms to be followed over 2 years. The primary endpoint is renal remission defined as normal creatine or return to baseline creatinine, inactive urinary sediment, and urine protein/creatinine ≤0.5.
The interventions: Group 1: rituximab without oral steroids (rituximab 1 g on weeks 0 & 2, 26 & 28, 52 & 54, 78 & 80, IV methylprednisolone 1 g on weeks 0 and 2); group 2: same as group 1 but with the addition of tapering oral steroids over 6 months; group 3: standard therapy (initial pulse steroids, MMF, tapering oral prednisone).