Comparison Between a Long Term and a Conventional Maintenance Treatment With Rituximab
Status:
Completed
Trial end date:
2018-08-16
Target enrollment:
Participant gender:
Summary
MAINRITSAN study compared Rituximab and azathioprine as maintenance therapy for
ANCA-associated vasculitides. In this study, Rituximab (5 infusions at D1, D15, M6, M12, M18)
was superior to azathioprine (2 mg/kg/day) to prevent relapses of AAV 28 months after the
inclusion (Guillevin et al. NEJM 2014). Nevertheless, in the follow-up study of MAINRITSAN,
up to 30% of patients experienced a relapse 38 months after the last rituximab infusion
(unpublished data). Right now, no randomized controlled study has been carried in order to
evaluate the best duration of the maintenance treatment with rituximab.
The investigators objective is to evaluate the efficacy of a long term rituximab treatment to
prevent relapses of ANCA-associated vasculitis in patients in remission after a first phase
of rituximab maintenance treatment.
The investigators will conduct a randomized placebo-controlled trial of a long term rituximab
maintenance treatment (46 months) against a conventional maintenance treatment (18 months).