Comparison Between a Long Term and a Conventional Maintenance Treatment With Rituximab

  • STATUS
    Not Recruiting
  • participants needed
    97
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 25 April 2021

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follow-up study of MAINRITSAN, up to 30% of patients experienced a relapse 38 months after the last rituximab infusion (unpublished data).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).

Details
Condition Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Treatment Rituximab, Placebo
Clinical Study IdentifierNCT02433522
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on25 April 2021

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