Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody
(ANCA) vasculitis following major European and US trials reported in 2010. After a time, its
effect wears off and the disease can return. This occurs in at least half of patients within
2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that repeating
rituximab every six months stops the disease returning and is safe.
The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and
whether it works better than the older treatments, azathioprine or methotrexate. It will also
tell us how long patients remain well after the repeated rituximab treatments are stopped,
and if repeated rituximab is safe. We should also learn useful information about the effects
of rituximab on quality of life and economic measures. The trial results will help decide the
best treatment for future patients who have their vasculitis initially treated with
rituximab.
RITAZAREM aims to recruit patients with established ANCA vasculitis whose disease has come
back 'relapsing vasculitis'. All patients will be treated with rituximab and steroids and we
anticipate that most will respond well. If their disease is under reasonable control after
four months, further treatment with either rituximab (a single dose ever four months for two
years) or azathioprine tablets will be chosen randomly. The patients in the rituximab and
azathioprine groups will then be compared. Patients will be in the trial for four years.
The study has been designed by members of the European Vasculitis Study group (EUVAS) and the
Vasculitis Clinical Research Consortium (VCRC). It will include 190 participants from 30
hospitals in Europe, the USA, Australia and Mexico.
RITAZAREM is being funded by Arthritis Research UK, the U.S. National Institutes of Health
and by Roche/Genentech.
Phase:
Phase 3
Details
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborators:
Arthritis Research UK Genentech, Inc. Roche Pharma AG University of Pennsylvania