RITAZAREM – An international, open label, randomized controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis
Principal Investigator: Patrick Nachman, MD
Sponsors: University of Pennsylvania, National Institutes of Health, and Roche/Genentech
Age Range: 18 years of age and above
Status: Ongoing; not enrolling
Purpose: The purpose of this international, multi-center study is to compare the efficacy of rituximab to azathioprine in the prevention of disease flare in patients with relapsing ANCA-associated vasculitis.
Study Procedures: Participants will be randomized to receive fixed-interval repeat rituximab dosing or azathioprine maintenance therapy.
Participation: Evaluations will be performed at months 0, 1.5, 3, 4, 8, 12, 16, 20, 24, 27, 30, 36, and every 6 months until the last patient enrolled has completed 12 months of follow up (36 months from study entry)
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