PDF(Pubmed)
Abstract：
BACKGROUND: Filgotinib was approved in Germany for treating patients with moderate to severe active ulcerative colitis in November 2021. It represents a preferential Janus kinase 1 inhibitor. The FilgoColitis study began recruiting immediately after approval and aims to assess filgotinib effectiveness under real-world conditions with a particular focus on patient-reported outcomes (PROs). The novelty of the study design is the optional inclusion of 2 innovative wearables, which could provide a new layer of patient-derived data.
OBJECTIVE: The study investigates quality of life (QoL) and psychosocial well-being of patients with active ulcerative colitis during long-term exposure to filgotinib. PROs related to QoL and psychometric profiles (fatigue and depression) are collected alongside with disease activity symptom scores. We aim to evaluate physical activity patterns collected by wearables as an addition to traditional PROs, patient-reported health status, and QoL in different phases of disease activity.
METHODS: This is a prospective, single-arm, multicentric, noninterventional, observational study with a sample size of 250 patients. QoL is assessed with validated questionnaires: the Short Inflammatory Bowel Disease Questionnaire (sIBDQ) for the disease-specific QoL, the EQ-5D for the general QoL, and the fatigue questionnaire (Inflammatory Bowel Disease-Fatigue [IBD-F]). Physical activity data are collected from patients using wearables (SENS motion leg sensor [accelerometry] and smartwatch, GARMIN vívosmart 4).
RESULTS: The enrollment started in December 2021 and was still open at the date of submission. After 6 months of study initiation, 69 patients were enrolled. The study is expected to be completed in June 2026.
CONCLUSIONS: Real-world data for novel drugs are important to assess effectiveness outside of highly selected populations represented by randomized controlled trials. We examine whether patients\' QoL and other PROs can be supplemented with physical activity patterns measured objectively. Use of wearables with newly defined outcomes represents an additional observational tool for monitoring disease activity in patients with inflammatory bowel disease.
BACKGROUND: German Clinical Trials Register DRKS00027327; https://drks.de/search/en/trial/DRKS00027327.
UNASSIGNED: DERR1-10.2196/42574.
OBJECTIVE: The study investigates quality of life (QoL) and psychosocial well-being of patients with active ulcerative colitis during long-term exposure to filgotinib. PROs related to QoL and psychometric profiles (fatigue and depression) are collected alongside with disease activity symptom scores. We aim to evaluate physical activity patterns collected by wearables as an addition to traditional PROs, patient-reported health status, and QoL in different phases of disease activity.
METHODS: This is a prospective, single-arm, multicentric, noninterventional, observational study with a sample size of 250 patients. QoL is assessed with validated questionnaires: the Short Inflammatory Bowel Disease Questionnaire (sIBDQ) for the disease-specific QoL, the EQ-5D for the general QoL, and the fatigue questionnaire (Inflammatory Bowel Disease-Fatigue [IBD-F]). Physical activity data are collected from patients using wearables (SENS motion leg sensor [accelerometry] and smartwatch, GARMIN vívosmart 4).
RESULTS: The enrollment started in December 2021 and was still open at the date of submission. After 6 months of study initiation, 69 patients were enrolled. The study is expected to be completed in June 2026.
CONCLUSIONS: Real-world data for novel drugs are important to assess effectiveness outside of highly selected populations represented by randomized controlled trials. We examine whether patients\' QoL and other PROs can be supplemented with physical activity patterns measured objectively. Use of wearables with newly defined outcomes represents an additional observational tool for monitoring disease activity in patients with inflammatory bowel disease.
BACKGROUND: German Clinical Trials Register DRKS00027327; https://drks.de/search/en/trial/DRKS00027327.
UNASSIGNED: DERR1-10.2196/42574.
摘要：
背景：Filgotinib于2021年11月在德国被批准用于治疗中度至重度活动性溃疡性结肠炎患者。它代表优选的Janus激酶1抑制剂。FilgoColitis研究在批准后立即开始招募，旨在评估filgotinib在现实条件下的有效性，特别关注患者报告的结果（PRO）。研究设计的新颖之处在于可选包含2种创新的可穿戴设备，这可以提供一层新的患者衍生数据。
目的：该研究调查了长期暴露于菲尔戈替尼的活动性溃疡性结肠炎患者的生活质量（QoL）和社会心理健康。与QoL和心理测量特征（疲劳和抑郁）相关的PRO与疾病活动症状评分一起收集。我们的目标是评估可穿戴设备收集的身体活动模式，作为传统专业人员的补充，患者报告的健康状况，和QoL在疾病活动的不同阶段。
方法：这是一个前瞻性的，单臂,多中心,非干预性，观察性研究，样本量为250例患者。QoL通过经过验证的问卷进行评估：针对特定疾病的QoL的简短炎症性肠病问卷（sIBDQ），一般QoL的EQ-5D，和疲劳问卷（炎症性肠病-疲劳[IBD-F]）。使用可穿戴设备（SENS运动腿传感器[加速度计]和智能手表，GARMINVívosmart4）。
结果：注册于2021年12月开始，在提交之日仍然开放。研究开始6个月后，共纳入69例患者。该研究预计将于2026年6月完成。
结论：新药的真实世界数据对于评估以随机对照试验为代表的高度选择人群以外的有效性很重要。我们检查患者的QoL和其他PRO是否可以通过客观测量的身体活动模式来补充。使用具有新定义结果的可穿戴设备代表了监测炎症性肠病患者疾病活动的另一种观察工具。
背景：德国临床试验注册DRKS00027327;https://drks。de/search/en/trial/DRKS00027327.
■DERR1-10.2196/42574。
目的：该研究调查了长期暴露于菲尔戈替尼的活动性溃疡性结肠炎患者的生活质量（QoL）和社会心理健康。与QoL和心理测量特征（疲劳和抑郁）相关的PRO与疾病活动症状评分一起收集。我们的目标是评估可穿戴设备收集的身体活动模式，作为传统专业人员的补充，患者报告的健康状况，和QoL在疾病活动的不同阶段。
方法：这是一个前瞻性的，单臂,多中心,非干预性，观察性研究，样本量为250例患者。QoL通过经过验证的问卷进行评估：针对特定疾病的QoL的简短炎症性肠病问卷（sIBDQ），一般QoL的EQ-5D，和疲劳问卷（炎症性肠病-疲劳[IBD-F]）。使用可穿戴设备（SENS运动腿传感器[加速度计]和智能手表，GARMINVívosmart4）。
结果：注册于2021年12月开始，在提交之日仍然开放。研究开始6个月后，共纳入69例患者。该研究预计将于2026年6月完成。
结论：新药的真实世界数据对于评估以随机对照试验为代表的高度选择人群以外的有效性很重要。我们检查患者的QoL和其他PRO是否可以通过客观测量的身体活动模式来补充。使用具有新定义结果的可穿戴设备代表了监测炎症性肠病患者疾病活动的另一种观察工具。
背景：德国临床试验注册DRKS00027327;https://drks。de/search/en/trial/DRKS00027327.
■DERR1-10.2196/42574。
