PDF(Pubmed)
Abstract：
BACKGROUND: The absence of reliable prognostic markers poses a challenge to the management of inflammatory bowel disease (IBD). Patients with aggressive disease may not receive sufficient treatment with conventional \'step-up\' therapy, whereas a top-down approach may expose patients with indolent disease to unnecessary treatment-related toxicity. The objective of the Nordic IBD treatment strategy trial (NORDTREAT) is to assess the feasibility of personalised therapy by stratifying patients according to a prognostic serum protein signature at diagnosis.
METHODS: NORDTREAT is a multicentre, biomarker-strategy design, open-label controlled trial. After screening consent, eligible patients are randomised (1:1) into one of two groups: a group with access to the protein signature and a group without access. In the access to protein signature group, patients displaying a protein signature suggestive of an increased risk of an aggressive disease course will be treated in line with a top-down treatment algorithm (anti-tumour necrosis factor agent with/without an immunomodulator). In contrast, those with a protein signature indicative of indolent disease will be excluded from the trial. Patients not in the access group receive treatment based on clinical management. This traditional management involves a stepwise escalation of treatment as determined by the investigator after failure of first-line treatment. After 52 weeks, outcomes are assessed in the subgroup of patients with a protein profile indicating a potentially severe disease trajectory. The primary endpoint is a composite of the proportion of patients with corticosteroid-free clinical and endoscopic remission at week 52. Surgical intervention due to IBD during follow-up will be defined as treatment failure.
BACKGROUND: Ethical approval has been obtained, and recruitment is underway at sites in four participating Nordic countries (Denmark, Iceland, Norway and Sweden). Following trial completion and data analysis, the trial results will be submitted for publication in peer-reviewed journals and presented at international conferences.
BACKGROUND: NCT05180175; Pre-results. EudraCT number: 2019-002942-19.
METHODS: NORDTREAT is a multicentre, biomarker-strategy design, open-label controlled trial. After screening consent, eligible patients are randomised (1:1) into one of two groups: a group with access to the protein signature and a group without access. In the access to protein signature group, patients displaying a protein signature suggestive of an increased risk of an aggressive disease course will be treated in line with a top-down treatment algorithm (anti-tumour necrosis factor agent with/without an immunomodulator). In contrast, those with a protein signature indicative of indolent disease will be excluded from the trial. Patients not in the access group receive treatment based on clinical management. This traditional management involves a stepwise escalation of treatment as determined by the investigator after failure of first-line treatment. After 52 weeks, outcomes are assessed in the subgroup of patients with a protein profile indicating a potentially severe disease trajectory. The primary endpoint is a composite of the proportion of patients with corticosteroid-free clinical and endoscopic remission at week 52. Surgical intervention due to IBD during follow-up will be defined as treatment failure.
BACKGROUND: Ethical approval has been obtained, and recruitment is underway at sites in four participating Nordic countries (Denmark, Iceland, Norway and Sweden). Following trial completion and data analysis, the trial results will be submitted for publication in peer-reviewed journals and presented at international conferences.
BACKGROUND: NCT05180175; Pre-results. EudraCT number: 2019-002942-19.
摘要：
背景：缺乏可靠的预后标志物对炎症性肠病（IBD）的治疗提出了挑战。患有侵袭性疾病的患者可能无法接受常规“逐步升级”疗法的充分治疗，而自上而下的方法可能会使患有惰性疾病的患者面临不必要的治疗相关毒性。北欧IBD治疗策略试验（NORDTREAT）的目的是通过根据诊断时的预后血清蛋白特征对患者进行分层来评估个性化治疗的可行性。
方法：NORDTREAT是一个多中心，生物标志物策略设计，开放标签对照试验。经过筛选同意，符合条件的患者被随机(1:1)分为两组:获得蛋白质标签的组和未获得蛋白质标签的组.在获得蛋白质签名组中，显示提示侵袭性疾病病程风险增加的蛋白质特征的患者将按照自上而下的治疗算法(抗肿瘤坏死因子剂有/无免疫调节剂)进行治疗.相比之下,那些具有表明无痛性疾病的蛋白质特征的患者将被排除在试验之外.非接入组的患者接受基于临床管理的治疗。这种传统管理涉及一线治疗失败后研究者确定的逐步升级治疗。52周后,在具有表明潜在严重疾病轨迹的蛋白质谱的患者亚组中评估结局.主要终点是52周时无皮质类固醇临床和内镜缓解的患者比例的复合。在随访期间由于IBD引起的手术干预将被定义为治疗失败。
背景：已获得伦理批准，正在四个参与的北欧国家(丹麦，冰岛,挪威和瑞典)。在试验完成和数据分析之后，试验结果将提交给同行评审期刊发表,并在国际会议上发表.
背景：NCT05180175；预结果。EudraCT编号：2019-002942-19。
方法：NORDTREAT是一个多中心，生物标志物策略设计，开放标签对照试验。经过筛选同意，符合条件的患者被随机(1:1)分为两组:获得蛋白质标签的组和未获得蛋白质标签的组.在获得蛋白质签名组中，显示提示侵袭性疾病病程风险增加的蛋白质特征的患者将按照自上而下的治疗算法(抗肿瘤坏死因子剂有/无免疫调节剂)进行治疗.相比之下,那些具有表明无痛性疾病的蛋白质特征的患者将被排除在试验之外.非接入组的患者接受基于临床管理的治疗。这种传统管理涉及一线治疗失败后研究者确定的逐步升级治疗。52周后,在具有表明潜在严重疾病轨迹的蛋白质谱的患者亚组中评估结局.主要终点是52周时无皮质类固醇临床和内镜缓解的患者比例的复合。在随访期间由于IBD引起的手术干预将被定义为治疗失败。
背景：已获得伦理批准，正在四个参与的北欧国家(丹麦，冰岛,挪威和瑞典)。在试验完成和数据分析之后，试验结果将提交给同行评审期刊发表,并在国际会议上发表.
背景：NCT05180175；预结果。EudraCT编号：2019-002942-19。
