Study Summary

Current conventional therapies for ANCA-associated vasculitis (AAV) are associated with high incidences of treatment failure, disease relapse, substantial toxicity, and patient morbidity and mortality. Rituximab is a monoclonal antibody that is currently used to treat a type of cancer called non-Hodgkin’s lymphoma. This study will evaluate the ability of rituximab together with glucocorticoids to induce disease remission in adults with severe forms of AAV, namely Wegener’s Granulomatosis or Microscopic Polyangiitis (WG and MPA).

This study will last at least 18 months. The study consists of two phases: a 6-month remission induction phase followed by a 12-month remission maintenance phase. All participants will receive at least 1 g of pulse IV methylprednisolone (or a dose-equivalent of another glucocorticoid preparation). Depending on the participant’s present condition, they may receive up to 3 days of IV methylprednisolone for a total of 3 g of methylprednisolone or a dose-equivalent. During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit.

Participants will be randomly assigned to one of two arms. Arm 1 participants will receive rituximab (375 mg/m2) infusions once weekly for 4 weeks and cyclophosphamide (CYC) placebo daily for 3 to 6 months. Arm 2 participants will receive rituximab placebo infusions once weekly for 4 weeks and CYC daily for 3 to 6 months. During the remission maintenance phase, participants in Arm 1 will discontinue CYC placebo and start oral azathioprine (AZA) placebo daily until Month 18. Participants in Arm 2 will discontinue CYC and start AZA daily until Month 18. Participants who fail treatment before Month 6 will be crossed over to the other treatment arm unless there are specific contraindications. Participants in either group who reach clinical remission before the remission induction phase may switch from CYC/placebo to AZA/placebo if directed by their physicians.

All participants will be followed for at least 18 months. Compensation is available to participating patients.

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