Martin Naomi H, Ibrahim Fowzia, Tom Brian, Galloway James, Wailoo Allan, Tosh Jonathan, Lempp Heidi, Prothero Louise, Georgopoulou Sofia, Sturt Jackie, Scott David L
Academic Department of Rheumatology, King's College London, Weston Education Centre, Cutcombe Road, Denmark Hill, London, SE5 9RJ, UK.
MRC Biostatistics Unit, Institute of Public Health, University Forvie Site, Robinson Way, Cambridge, CB2 0SR, UK.
Trials. 2017 Dec 8;18(1):591. doi: 10.1186/s13063-017-2330-8.
Uncontrolled active rheumatoid arthritis can lead to increasing disability and reduced quality of life over time. 'Treating to target' has been shown to be effective in active established disease and also in early disease. However, there is a lack of nationally agreed treatment protocols for patients with established rheumatoid arthritis who have intermediate disease activity. This trial is designed to investigate whether intensive management of disease leads to a greater number of remissions at 12 months. Levels of disability and quality of life, and acceptability and cost-effectiveness of the intervention will also be examined.
The trial is a 12-month, pragmatic, randomised, open-label, two-arm, parallel-group, multicentre trial undertaken at specialist rheumatology centres across England. Three hundred and ninety-eight patients with established rheumatoid arthritis will be recruited. They will currently have intermediate disease activity (disease activity score for 28 joints assessed using an erythrocyte sedimentation rate of 3.2 to 5.1 with at least three active joints) and will be taking at least one disease-modifying anti-rheumatic drug. Participants will be randomly selected to receive intensive management or standard care. Intensive management will involve monthly clinical reviews with a specialist health practitioner, where drug treatment will be optimised and an individualised treatment support programme delivered based on several principles of motivational interviewing to address identified problem areas, such as pain, fatigue and adherence. Standard care will follow standard local pathways and will be in line with current English guidelines from the National Institute for Health and Clinical Excellence. Patients will be assessed initially and at 6 and 12 months through self-completed questionnaires and clinical evaluation.
The trial will establish whether the known benefits of intensive treatment strategies in active rheumatoid arthritis are also seen in patients with established rheumatoid arthritis who have moderately active disease. It will evaluate both the clinical and cost-effectiveness of intensive treatment.
Current Controlled Trials, ID: ISRCTN70160382 . Registered on 16 January 2014.
未得到控制的活动性类风湿关节炎会随着时间推移导致残疾加剧和生活质量下降。“达标治疗”已被证明在活动性确诊疾病以及早期疾病中均有效。然而，对于确诊的类风湿关节炎且疾病活动处于中等程度的患者，缺乏全国统一认可的治疗方案。本试验旨在研究强化疾病管理是否会在12个月时带来更多的病情缓解。还将检查残疾水平和生活质量，以及干预措施的可接受性和成本效益。
该试验是一项为期12个月的务实、随机、开放标签、双臂、平行组、多中心试验，在英格兰各地的专科风湿病中心进行。将招募398例确诊的类风湿关节炎患者。他们目前疾病活动处于中等程度（使用红细胞沉降率评估的28个关节疾病活动评分在3.2至5.1之间，且至少有三个活动关节），并且正在服用至少一种改善病情抗风湿药物。参与者将被随机选择接受强化管理或标准护理。强化管理将包括每月由专科医生进行临床复查，在此过程中优化药物治疗，并根据动机性访谈的若干原则提供个性化治疗支持计划，以解决已确定的问题领域，如疼痛、疲劳和依从性。标准护理将遵循标准的当地流程，并符合英国国家卫生与临床优化研究所当前的英国指南。患者将通过自行填写问卷和临床评估在初始阶段以及6个月和12个月时进行评估。
该试验将确定强化治疗策略在活动性类风湿关节炎中已知的益处是否也见于确诊的类风湿关节炎且疾病活动处于中等程度的患者。它将评估强化治疗的临床效果和成本效益。
当前受控试验，编号：ISRCTN70160382。于2014年1月16日注册。
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