Table 4: Clinical Events Categorized as Treatment Failures

In this protocol, treatment failure that may lead to treatment modification is defined as any one of the following:
  • Death caused by persistent disease activity or by severe infusion reactions within 24 hours of rituximab/placebo infusion.
  • Failure to achieve disease response by the month 1 study visit, i.e., 1 week after the fourth infusion (visit V5). These participants are considered early treatment failures and included in the ITT analysis. They are subsequently treated according to best medical judgement.
  • A severe disease flare or a limited flare that requires CYC that occurs after disease response or after achievement of clinical remission or complete remission between visit V5 (1 week after the last rituximab/placebo infusion) and visit V8 (month-6 study visit) or between V5A and V8A.
  • Inability to complete glucocorticoid tapering by month 6 (visit V8) because of persistent, recurrent, or progressive disease activity, as measured by the BVAS/WG.
  • Inability to complete the full course of rituximab (or rituximab placebo) infusions because of treatment-related adverse effects. This participant will be considered an early treatment failure, included in the ITT analysis, and subsequently treated according to Best Medical Judgment.
  • A limited flare within the first 6 months after randomization that cannot be controlled by increasing the prednisone dose.
  • A new severe or limited flare requiring CYC after visit V8 (month 6 study visit) and before visit V12 (month 18 study visit) or after visit V8A (month-6 study visit) and before visit V12 (month-18 study visit after V1A).
  • Adverse effects related to CYC/Placebo or AZA/Placebo (e.g., drug-induced cystitis) leading to permanent discontinuation of these study therapies.
  • Neutropenia (WBC < 3,000/mm3) that develops during receipt of rituximab/placebo infusions and that lasts more than 2 weeks.