期刊
TRIALS
卷 18, 期 -, 页码 -出版社
BMC
DOI: 10.1186/s13063-017-1857-z
关键词
ANCA-associated vasculitis; RITAZAREM; Rituximab; Azathioprine; Randomized clinical trial
资金
- Arthritis Research UK
- National Institute for Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Center for Advancing Translational Science (NCATS)
- Roche/Genentech
- Japanese Ministry of Health, Labour, and Welfare
- National Institute for Health Research [NF-SI-0515-10015] Funding Source: researchfish
- Versus Arthritis [19706] Funding Source: researchfish
Background: Rituximab is effective as therapy for induction of remission in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). However, the effect of rituximab is not sustained, and subsequent relapse rates are high, especially in patients with a history of relapse. There is a need to identify whether maintenance therapy with rituximab is superior to the current standard of azathioprine or methotrexate for prevention of relapse following induction with rituximab. Methods/design: RITAZAREM is an international, multicenter, open-label, randomized controlled trial designed to demonstrate the superiority of repeated doses of intravenous rituximab compared to daily orally administered azathioprine as a relapse prevention strategy in patients with AAV with relapsing disease who undergo induction of remission with rituximab. Patients with AAV will be recruited at the time of relapse and will receive rituximab and glucocorticoid induction therapy. If the disease is controlled by 4 months, patients will be randomized in a 1: 1 ratio to receive rituximab (1000 mg every 4 months for five doses) or azathioprine (2 mg/kg/day) as maintenance therapy. Patients will be followed for a minimum of 36 months. The primary outcome is the time to disease relapse. It is estimated that 190 patients will need to be recruited to ensure that at least 160 are randomized. Discussion: The RITAZAREM trial will provide the largest trial dataset for the use of rituximab as remission-induction therapy for patients with AAV comparing two remission-maintenance strategies following induction with rituximab, and explore whether prolonged B-cell depletion leads to sustained treatment-free remissions after discontinuation of immunosuppressive therapy.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据