The RITAZAREM Trial

An international, open-label, randomized controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis.

Study Design

An international, open-label, randomized, controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis (AAV). 160 participants will be randomized 1:1 to receive fixed-interval repeat rituximab dosing or azathioprine maintenance therapy.

Primary Objective

To demonstrate the superiority of rituximab against azathioprine in the prevention of disease flare in AAV patients with relapsing disease.


Trial Chief Investigators: David Jayne and Peter A. Merkel

Sponsors: Cambridge University Hospitals NHS Foundation Trust and the University of Pennsylvania

Funding: Cambridge University Hospitals NHS Foundation Trust (UK), Arthritis Research UK, University of Pennsylvania (US), National Institute of Arthritis and Musculoskeletal and Skin Diseases (US), Genentech, and Roche Pharma AG.

EudraCT Number: 2012-001102-14

ClincalTrials.gov Number: NCT01697267

 

Funded By:

Arthritis Research UK   |   National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)   |   Genentech   |   Roche Pharma AG