Low-dose glucocorticoids plus rituximab versus high-dose glucocorticoids plus rituximab for remission induction in ANCA-associated vasculitis (LoVAS): protocol for a multicentre, open-label, randomised controlled trial. Issue 12 (14th December 2017)

• Record Type: Journal Article
• Authors: Furuta, Shunsuke; Sugiyama, Takao; Umibe, Takeshi; Kaneko, Yuko; Amano, Koichi; Kurasawa, Kazuhiro; Nakaomi, Daiki; Hiraguri, Masaki; Hanaoka, Hideki; Sato, Yasunori; Ikeda, Kei; Nakajima, Hiroshi
• Other Names: author non-byline.; Nagashima Kengo author non-byline.; Kagami Shin-ichiro author non-byline.; Kashiwakuma Daisuke author non-byline.; Watanabe Hiroshi author non-byline.; Motojima Shinji author non-byline.; Nakashita Tamao author non-byline.; Kobayashi Yoshihisa author non-byline.; Matsumura Ryutaro author non-byline.; Oya Yoshihiro author non-byline.; Kita Yasuhiko author non-byline.; Wada Yoko author non-byline.; Narita Ichiei author non-byline.; Ogawa Noriyoshi author non-byline.; Suzuki Daisuke author non-byline.; Kono Hajime author non-byline.; Uchida Shunya author non-byline.; Fujigaki Yoshihide author non-byline.; Hiromura Keiju author non-byline.; Sakairi Toru author non-byline.; Owada Takayoshi author non-byline.; Kawashima Hirotoshi author non-byline.; Matsuki Ayako author non-byline.; Yamagata Mieko author non-byline.; Ohta Yuichiro author non-byline.; Sakai Ryota author non-byline.; Ishii Tomonori author non-byline.; Kawakami Atsushi author non-byline.; Sumida Takayuki author non-byline.; Watanabe Norihiko author non-byline.; Yasuda Shinsuke author non-byline.; Kumanogoh Atsushi author non-byline.; Kohsaka Hitoshi author non-byline.; Tanaka Yoshiya author non-byline.; Komatsuda Atsushi author non-byline.; Shimojima Yoshihiro author non-byline.; Sekigawa Iwao author non-byline.; Hanaoka Hironari author non-byline.; Makino Yuichi author non-byline.; Yoshimi Ryusuke author non-byline.; Hayashi Taichi author non-byline.; Otani Hiroshi author non-byline.;
• Is Part Of: BMJ open. Volume 7:Issue 12(2017)
• Publication Date: 2017-12-14
• Subjects: rheumatology -- clinical pharmacology; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2017-018748
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Antineutrophil cytoplasm antibody-associated vasculitis (AAV) is a form of systemic vasculitis. The current standard induction therapy with the combination of high-dose glucocorticoids and cyclophosphamide or rituximab has high remission rates of 80%–90%. However, it is also associated with various side effects, including death due to infection or cardiovascular disease. There is an unmet medical need of a new therapy to reduce side effects. Methods and analysis: This is a phase IV multicentre, open-label, randomised controlled trial that aims to evaluate the efficacy and safety of a new remission induction regimen with the combination of low-dose glucocorticoids and rituximab. Newly diagnosed patients with AAV will be assessed for eligibility at 34 tertiary rheumatology/nephrology centres in Japan. One hundred and forty patients will be randomised (1:1) to receive low-dose prednisolone (0.5 mg/kg daily) plus rituximab (375 mg/m 2 weekly) or high-dose prednisolone (1 mg/kg daily) plus rituximab. The trial consists of remission induction and maintenance phases. The primary endpoint of the study is the remission rate at 6 months (induction phase). Relapse and long-term safety profile will also be assessed until 24 months (maintenance phase). Ethics and dissemination: The protocol was first approved by the Institutional Review Board of Chiba University Hospital (reference number: G25051), and then approved by each participating site. The trial was registered at the University hospital Medical Information Network (UMIN) clinical registry (UMIN000014222) and ClinicalTrials.gov registry (NCT02198248 ). The Low-dose Glucocorticoid Vasculitis Induction Study (LoVAS) trial is currently ongoing and is due to finish in September 2019. The findings of this trial will be disseminated to participants through peer-reviewed publications and presented at national and international conferences in accordance with the Consolidated Standards of Reporting Trials (CONSORT) Statement. Trial registration number: UMIN000014222; NCT02198248 .