Table 2 Intervention in both arms over time
Group A (RITUX +MMF) | Group B (Repeated RITUX only) | |
|---|---|---|
At randomization | First course rituximab. Stop steroid at 14 days. | First course rituximab. Stop steroid at 14 days. |
At month 4 | Add MMF and continue over study period unless any adverse event | – |
At month 8 | – | 2nd course prophylactic rituximab if B cell normalize. |
At month 16 | – | 3rd course prophylactic rituximab if B cell normalize. |
At month 24 | FOLLOW-UP COMPLETED | |
Any relapse during the observation period will be treated with prednisone (2 mg/kg/day) until remission, followed by 1.5 mg/kg alternate day for 1 month. | ||
If > = 2 relapses during any 6 month period, treat by | 2nd course rituximab if B cell in normal range. Continue MMF. | Add MMF. |