Vasculitis Clinical Trial
Official title:
Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI)
Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type
of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's
granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody
used to treat certain types of cancer. The purpose of this study is to determine the
effectiveness of rituximab in treating patients with WG and MPA.
Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce
disease remission by Month 6.
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 used to treat non-Hodgkin's
lymphoma. This study will evaluate the efficacy of rituximab with glucocorticoids in
inducing disease remission in patients with severe forms of AAV (WG and MPA).
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
intravenous methylprednisolone or a dose-equivalent of another glucocorticoid preparation.
Depending on the participant's condition, he or she may receive up to 3 days of intravenous
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.
Next, participants will be randomly assigned to one of two arms. Arm 1 participants will
receive rituximab (375 mg/m^2) 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 they complete 6 months of therapy may switch from
CYC/placebo to AZA/placebo if directed by their physicians.
All participants will be followed for at least 18 months. Initially, study visits are
weekly, progressing to monthly and then quarterly visits as the study proceeds. Blood
collection will occur at each study visit.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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