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标题：Ultra-low dose of rituximab in rheumatoid arthritis: study protocol for a randomised controlled trial
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作者：Alfons A. den Broeder ; Lise M. Verhoef ; Jaap Fransen 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2017
卷号：18
期号：1
页码：403
DOI：10.1186/s13063-017-2134-x
语种：English
出版社：BioMed Central
摘要：Background A standard low-dosing schedule of rituximab (RTX; 2 × 500 mg or 1 × 1000 mg) is as effective for active rheumatoid arthritis (RA) as the registered dose (2 × 1000 mg). Moreover, several small uncontrolled studies suggest that even lower-dosed treatment with RTX also leads to good treatment response in patients with RA. Retreatment with such an ‘ultra-low’ dose RTX in patients who responded well to RTX induction treatment is of special interest, as long-term use of lower RTX doses may lead to shorter infusion duration, lower risk of adverse events and lower costs. However, the effect of ultra-low dose of RTX has not been investigated using a controlled trial of proper design and dimensions. Methods/Design REDO is an investigator driven six-month pragmatic, double-blind, randomised controlled non-inferiority trial on the effects of ultra-low-dose RTX (1 × 500 or 1 × 200 mg) compared to standard low dose (1 × 1000 mg) in RA patients who are being retreated with RTX. A total of 140 RA patients, having reached low disease activity (DAS28CRP Discussion This study protocol shares characteristics of both early dose finding trials as well as late pragmatic clinical studies. Several choices in the design of this trial are described and possible consequences for RA treatment and expected biosimilar introduction are discussed. Trial registration Dutch Trial Register, NTR6117 . Registered on 15 November 2016 (CMO NL57520.091.16 , 8 November 2016)
关键词：Rheumatoid arthritis ; Dose reduction ; Rituximab ; Low dose ; Retreatment ; Randomised controlled trial ; Non-inferiority ; Design ; Decremental cost-effectiveness ratio (DCER)