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ExploriNg DUrable Remission with Rituximab in ANCA-associatEd vasculitis (ENDURRANCE trial): protocol for a randomised controlled trial by Ebru Dirikgil; Jolijn R van Leeuwen; Obbo W Bredewold; Argho Ray; Jacqueline T Jonker; Darius Soonawala; Hilde H F Remmelts; Bastiaan van Dam; Willem Jan Bos; Cees van Kooten; Joris Rotmans; Ton Rabelink; Y K Onno Teng is a Medicine article available to read on EtoBox.
What is ExploriNg DUrable Remission with Rituximab in ANCA-associatEd vasculitis (ENDURRANCE trial): protocol for a randomised controlled trial about?
## Introduction Both rituximab (RTX) and cyclophosphamide (CYC) are effectively used in combination with steroids as remission induction therapy for patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Several studies have shown that the effect on achieving (clinical) remission, frequency and severity of relapses is equivalent for both therapies, but there is accumulating data that the long-term safety profile of RTX might outperform CYC. Combination of RTX with low-dose CYC (LD-CYC) has been investigated in only a few uncontrolled cohort studies, in which clinical remission and a favourable immunological state with low relapse rates was quickly achieved. In this randomised controlled trial, we aim to investigate whether the combination treatment (RTX+LD CYC) is superior in comparison to standard care with RTX only. ## Methods and analysis This study is an open-label, multicentre, 1:1 randomised, prospective study for patients with AAV with generalised disease, defined as involvement of major organs, that is, kidneys, lungs, heart and nervous system. In total, 100 patients will be randomised 1:1 to receive either remission induction therapy with sta
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- Author
- Ebru Dirikgil; Jolijn R van Leeuwen; Obbo W Bredewold; Argho Ray; Jacqueline T Jonker; Darius Soonawala; Hilde H F Remmelts; Bastiaan van Dam; Willem Jan Bos; Cees van Kooten; Joris Rotmans; Ton Rabelink; Y K Onno Teng
- Published
- 2022
- Language
- EN
- Field
- Medicine (Health Sciences)