Between 29 December 2017 and 5 January 2022, in a multicentre, open-label, biomarker-stratified, interventional clinical trial (PROFILE), 386 adult patients with newly diagnosed active Crohn’s disease were randomly assigned to two groups: top-down (early combined immunosuppression with infliximab (a TNF monoclonal antibody) and an immunomodulator) or accelerated step-up (conventional) treatment.

The patients (46% women and 54% men) were stratified by a putative prognostic blood-based biomarker derived from T cell transcriptional signatures and severity and location of inflammation via endoscopy (mild, moderate or severe, and colonic or other, respectively).

2017年12月29日至2022年1月5日期间，在一项多中心、开放标签、生物标志物分层、介入性临床试验（PROFILE）中，386名新诊断的活动性克罗恩病成年患者被随机分为两组：自上而下（早期联合使用英夫利昔单抗（一种 TNF 单克隆抗体）和免疫调节剂进行免疫抑制或加速升级（传统）治疗。

患者（46% 女性和 54% 男性）根据推定的基于血液的预后生物标志物进行分层，该生物标志物源自 T 细胞转录特征以及通过内窥镜检查炎症的严重程度和位置（分别为轻度、中度或重度，以及结肠或其他）。